Clinical trial NCT04208516
Conditions: Postoperative Pain
Keywords: intravenous lidocaine erector spinae plane block quadratus lumborum block thoracic surgery abdominal surgery continuous peripheral nerve block
Sponsor: Jeremy Kearns
Start date: 2021-05-26; Completion date: 2022-08-18
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multimodal analgesic regimen including regional anesthesia is used at UPMC Shadyside for primary thoracic and major abdominal surgeries. The current standard-of-care regional anesthesia techniques include Erector Spinae Plane (ESP) block for video assisted thorascopic surgery (VATS) and Quadratus Lumborum (QL) block for major abdominal surgery. These blocks are routinely administered as a continuous catheter technique in order to extend the duration of postoperative analgesia. Although rare, continuous nerve block techniques carry risks and limitations, including catheter dislodgement, migration, kinking and leaking at the site, bleeding, and infection. They are also much more expensive to perform and maintain than single-injection nerve blocks at this institution. Perioperative intravenous (IV) lidocaine is one of the safest local anesthetics, and its use has been shown to provide analgesia and reduce opioid requirements. Furthermore, it has been hypothesized that part of the analgesic efficacy of continuous peripheral nerve blocks may be due to the systemic effects of the local anesthetic infused at the site. Therefore, it is possible that the combination of a single block followed by an infusion of IV lidocaine may provide the same benefits as a continuous nerve block at a lower cost. The purpose of this study is to show that a single block technique plus IV lidocaine is non-inferior to a continuous block technique. For the purpose of this study we chose two surgical models--VATS and major abdominal surgery--and ESP and QL blocks, respectively. The study will be conducted as a prospective, randomized (1:1), open-label, active-comparator, noninferiority trial. The study will prospectively investigate the efficacy of continuous block versus single block plus IV lidocaine infusion for postoperative pain management in patients undergoing primary unilateral VATS or primary major abdominal surgery.

Detailed description:
After obtaining a signed informed consent, participating patients will be randomized by computer generated random numbers to either the control group to receive continuous Erector Spinae Plane block (in the case of thoracic surgery) or continuous Quadratus Lumborum block (in the case of abdominal surgery), or the treatment group to receive single shot Erector Spinae Plane block (in the case of thoracic surgery) or single shot Quadratus Lumborum block (in the case of abdominal surgery) with postoperative intravenous lidocaine infusion. Subjects will be randomized in a 1:1 ratio. Randomization will take place via an opaque envelope containing the treatment group allocation that will be given to the anesthesiologist performing the block after informed consent is signed. Procedures will take place in the UPMC Shadyside pre-operative block area. The expected duration of nerve block procedures is 10-20 minutes.

If the patient is randomized to the continuous nerve block group and is undergoing thoracic surgery, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach:

Continuous ESP Block Approach: The patient will be positioned in seated position with side or sides to be blocked marked. The T5 spinous process will be identified by palpation starting with C7 and continuing caudad. C7 is the most prominent spinous process anatomically. The T5 spinous process will be marked with a marking pen. The block area will be cleaned using 2% chlorhexidine solution. The entire block procedure is performed under strict aseptic technique. An ultrasound probe covered in a sterile probe cover will be placed at the T5 spinous process in a cephalad to caudad orientation and moved lateral until the T5 transverse process is identified. 1-2ml of 1% lidocaine will be administered just above the ultrasound probe for local skin infiltration. An 18 gauge Tuohy needle will then be inserted in plane in a cephalad to caudad direction under ultrasound visualization until the tip of the needle touches the T5 transverse process. The T5 transverse process is the anatomical target for this block. 20ml of 0.5% ropivacaine will then be injected using slow fractionated injection, aspirating every 5ml to ensure the needle tip is not intravascular. Local anesthetic spread in the appropriate plane will be confirmed with ultrasound. Once injection is complete, a 20 gauge nonstimulating catheter will be inserted through the Tuohy needle. Catheter tip placement will be confirmed with ultrasound. If bilateral blocks are to be performed, the procedure will then be repeated on the contralateral side. Upon patient arrival to PACU, a continuous infusion of 0.25% lidocaine at 10ml/hr per side blocked via ESP catheter will be initiated and continued for 72 hours or until 12 hours prior to patient discharge.

If the patient is randomized to the continuous nerve block group and is undergoing abdominal surgery, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach:

Continuous QL Block Approach: The patient will be positioned in lateral decubitus position with the side to be blocked facing up and the side or sides to be blocked marked. The block area will be cleaned using 2% chlorhexidine solution. The entire block procedure is performed under strict aseptic technique. An ultrasound probe covered in a sterile probe cover will be placed transversally between the iliac crest and the costal margin at the level of the anterior axillary line and the three muscles of the anterolateral abdominal wall (external oblique, internal oblique and transversus abdominis) will be identified. The probe will then be moved posteriorly until the transversus abdominis muscle (TAM) tapers off into its aponeurosis approximately at the level of the posterior axillary line, and posteriorly to this the intersection of the transversalis fascia with the lateral side of the QL muscle will be identified. An 18 gauge Tuohy needle will then be inserted in plane in an anterior to posterior direction until the tip of the needle is visualized at the intersection of the transversalis fascia with the lateral side of the QL muscle. The intersection of the transversalis fascia with the lateral side of the QL muscle is the anatomical target for this block. Once the initial injection of local anesthetic is complete, a 20 gauge nonstimulating catheter will be inserted through the Tuohy needle. Catheter tip placement will be confirmed with ultrasound. If bilateral blocks are to be performed, the patient will be repositioned, the area to be blocked will be cleaned and prepared in a strict aseptic fashion as described above, and the procedure will then be repeated on the contralateral side. Upon patient arrival to PACU, a continuous infusion of 0.25% Lidocaine at 10ml/hr per side blocked via QLB catheter will be initiated and continued for 72 hours or until 12 hours prior to patient discharge.

If the patient is randomized to the single block plus IV lidocaine group and is undergoing thoracic surgery, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach:

Single Shot ESP Block with Postoperative IV Lidocaine Approach: The same technique described for the CESP will be used except that in this case a single ESP block will be performed. A 22 gauge Tuohy needle will be used to perform these blocks. After the proper positioning of the needle 20ml of 0.5% ropivacaine plus, 4mg dexamethasone, plus 30mcg dexmedetomidine will be deposited. In the recovery room an infusion of IV lidocaine at 50mg/hr for be initiated for 72 hours or until 12 hours prior to patient discharge.

If the patient is randomized to the single block plus IV lidocaine group and is undergoing abdominal surgery, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach:

Single Shot QL Block with Postoperative IV Lidocaine Approach: The same technique described for the CQL will be used except that a single QL block will be performed. A 22 gauge Tuohy needle will be used to perform these blocks. After the proper positioning of the needle 20ml of 0.5% ropivacaine plus, 4mg dexamethasone, plus 20mcg dexmedetomidine per injection site (30mcg if unilateral block only) will be deposited. Upon patient arrival to PACU, a continuous infusion of intravenous lidocaine at 50mg/hr will be initiated and continued for 72 hours or until 12 hours prior to patient discharge.

Anesthetic Management: Both treatment groups will receive the standard anesthetic technique and multimodal analgesic technique at our institution, including preoperative gabapentin 300mg PO and acetaminophen 1000mg PO, intraoperative IV propofol infusion-based general anesthetic combined with sub-anesthetic dose IV ketamine infusion, IV dexmedetomidine infusion, IV acetaminophen, and avoidance of intraoperative opioids. Postoperative pain management will also follow standard protocol, using IV hydromorphone (0.2-0.3 mg) and PO oxycodone (5-10 mg) on request by the patient for moderate to severe pain (VAS \>5), scheduled ketamine 20-50mg PO q 8hrs for 48 hours, scheduled acetaminophen 1000mg IV or PO q 6hrs, scheduled gabapentin 100-300mg PO at bedtime, and dexmedetomidine infusion 0.2mcg/kg/hr IV for 24 hours if the patient is located in the Intensive Care Unit.

After surgery, the patient will be followed by the blinded research team for incidence of adverse events, as well as the collection of the primary and secondary outcome measures. Pain assessment will be done by nurses in the PACU and on the floor using Numeric Pain Rating Scale, with 0 meaning no pain and 10 meaning worst possible pain. Opioid medication consumption, pain scores, local anesthetic medication consumption, serum lidocaine levels, and adverse effects will be recorded on worksheets included in patient research folders, with each study participant having their own research folder identified only by randomly assigned patient study number.

The research coordinator responsible for data collection will remain blinded to the patient's group allocation, and will not become unblinded during the data collection process because data will be collected from the patient's medical record and will not involve physically observing the patient (which would otherwise result in unblinding since the presence or absence of a perineural catheter and patient pump status would make the group allocation obvious). However, this information will not be obtainable when collecting data from the medical record. It is not possible to blind nursing staff or the patient to the patient's group allocation because the presence or absence of a visible perineural catheter will make the group allocation obvious.

Arms: arm 1: A total of 30 subjects equally distributed to either continuous Erector Spinae Plane block for unilateral thoracic surgery , or continuous Quadratus Lumborum block for major abdominal surgery. Patients in this group will receive 20ml 0.5% ropivacaine per block performed after positioning of the needle followed by continuous perineural infusion of 0.25% lidocaine (10ml/hr) beginning in the post-anesthesia care unit (PACU) and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution. arm 2: A total of 30 subjects equally distributed to either Erector Spinae Plane block for unilateral thoracic surgery, or Quadratus Lumborum block for major abdominal surgery, will be included . Patients in this group will receive 20ml 0.5% ropivacaine, 4mg dexamethasone, and 20mcg dexmedetomidine (30mcg if only one block is performed) per block after proper positioning of the Tuohy needle. Upon patient arrival in the recovery room a continuous infusion of IV lidocaine 50 mg /hr will be started and continued for 72 hours or until 12 hours prior to patient discharge, whichever comes first, which is standard of care at this institution.
Interventions: intervention 1: Continuous Erector Spinae Plane Nerve Block intervention 2: Continuous Quadratus Lumborum Nerve Block intervention 3: Single Erector Spinae Plane Nerve Block intervention 4: Single Quadratus Lumborum Nerve Block intervention 5: Lidocaine IV intervention 6: Ropivacaine 0.5% Injectable Solution intervention 7: Dexamethasone intervention 8: Dexmedetomidine intervention 9: Lidocaine
Intervention descriptions: intervention 1: To be administered to subjects in the active comparator group receiving primary unilateral thoracic surgery. intervention 2: To be administered to subjects in the active comparator group receiving primary major abdominal surgery. intervention 3: To be administered to subjects in the experimental group receiving primary unilateral thoracic surgery. intervention 4: To be administered to subjects in the experimental group receiving primary major abdominal surgery. intervention 5: To be given postoperatively as a continuous infusion at a dose of 50 mg/hr in the experimental group. intervention 6: To be used in both treatment arms as nerve block initial bolus injection. intervention 7: To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution. intervention 8: To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution. intervention 9: To be used perineurally as a 0.25% solution in the active comparator group at a rate of 10 ml/hr per perineural catheter.

Protocol documents:
Prot_SAP_000.pdf: 
Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
Study Title: A Prospective, Randomized, Active-Comparator, Open-Label, Non-Inferiority Study 
of the Efficacy of Continuous Nerve Block vs. Single block plus intravenous Lidocaine for Post-
Operative Pain 
 
NCT04208516 
 
Principal Investigator: Jeremy Kearns, MD 
 
Source of Support: None 
 
Last Approval: December 07, 2021 
 
 
 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
 
Protocol Title: A Prospective, Randomized, Active-Comparator, Open-Label, Non-Inferiority 
study of the efficacy of Continuous nerve block vs Single block plus Intravenous Lidocaine for 
postoperative pain. 
 
Principal Investigator: Jeremy Kearns, MD 
 
Faculty Mentor:  
Jacques Chelly, MD, PhD, MBA 
 
Co-Investigators: 
David Bartlett, MD 
Bruce Ben-David, MD 
 
 
 
Mohammad Choudry, MD 
 
 
 
Neil Christie, MD 
 
 
 
Rajeev Dhupar, MD 
 
 
 
Matthew Holtzman, MD 
Sharad Khetarpal, MD 
Olugbenga Okusanya, MD 
James Pingpank, MD 
Carl Rest, MD 
Inderpal Sarkaria, MD 
Hung Tran, MD 
Anna Uskova, MD 
Gabriel Wilner, MD 
 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
 
Background 
A multimodal approach to perioperative pain including regional anesthesia is recommended for 
thoracic and abdominal surgeries(1, 5, 6, 8, 17, 18, 29, 35, 38, 39, 42, 47). Thoracic paravertebral blocks 
(TPVB) have been demonstrated to be effective for the management of perioperative pain 
following thoracic and abdominal surgery, but widespread adoption of this technique is limited 
by the requirement for advanced training(5, 8, 17, 38, 42, 47). In the last several years, various fascial 
plane blocks including the erector spinae plane (ESP) and quadratus lumborum (QL) block have 
emerged as an alternative to TPVB. These techniques have experienced a surge in popularity in 
clinical practice because they are technically easier and less prone to the serious complications 
of TPVB while retaining similar clinical efficacy(1, 8, 29, 40). In our institution, both ESP and QL 
blocks in combination with a multimodal approach have become the standard of care for 
perioperative pain management in patients undergoing thoracic and abdominal surgeries, 
respectively. 
 
The ESP block, originally described by Forero et al, involves injection of local anesthetic under 
ultrasound guidance in the plane between the erector spinae muscle and the thoracic 
transverse processes (1, 8, 24, 38, 39, 42). The proposed mechanism of action of the ESP block is 
spread of local anesthetic to the paravertebral space, blocking the ventral and dorsal rami of 
thoracic spinal and sympathetic nerves (1, 8, 18, 42). The ESP block has been reported to be an 
effective analgesic technique for a variety of surgical procedures including video-assisted 
thoracoscopic surgery (VATS) (1, 3, 8, 13, 17, 18, 29, 35, 42, 44). This literature includes a randomized 
controlled trial by Fang et al, who found no difference in pain scores between patients who 
received ESP and TPVB following thoracotomy(17). 
 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
The Quadratus Lumborum block (QLB) was first described by Blanco (2007) as a variant of the 
traditional Transversus Abdominis Plane block (TAP). The QLB involves injection of local 
anesthetic between the quadratus lumborum muscle and the thoracolumbar fascia (TLF), 
resulting in spread along the TLF to the paravertebral space and to the celiac ganglion or 
sympathetic trunk via splanchnic nerves (2, 9, 12,15, 41). QLB has been described as an effective 
alternative analgesic technique to TPVB for a wide variety of abdominal and urologic surgeries(2, 
3, 7, 10, 14, 19, 25, 26, 32, 33, 46, 48, 49). 
 
Although significant improvements in postoperative analgesia have been reported with the use 
of single-injection ESP and QL fascial plane blocks, the relatively short lasting effects of these 
blocks have led to the placement of a perineural catheter to extend the duration of perioperative 
analgesia(9, 20, 21, 24, 34, 35, 37, 50). Although rare, continuous blocks carry their own set of risks and 
limitations, including catheter dislodgement, migration, kinking and leaking at the site, 
increased risk of bleeding, especially in case of concomitant use of anticoagulants, and 
infection(4, 20, 23, 31, 36). Lastly, from a cost point of view, the use of continuous nerve blocks is 
overall more expensive compared to single block, especially in our institution where the pump 
used to continuously infuse the local anesthetic mixture requires disposal and much more 
expensive cartridges ($48 vs $15). 
 
Perioperative intravenous (IV) lidocaine is considered one of the safest local anesthetics and its 
use has been shown to provide analgesia and reduce opioid requirements, and to shorten the 
time to return of bowel function and decrease hospital length of stay following colorectal 
surgery(11, 27, 28, 30, 43, 45). Furthermore, it has been hypothesized that part of the analgesic efficacy 
of continuous peripheral nerve blocks may be due to the systemic effects of the local anesthetic 
infused at the site(27, 43). Therefore, it is possible that the combination of a single block followed 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
by an infusion of IV lidocaine may provide the same benefits as a continuous nerve block at a 
significantly lower cost. Thus, our database review indicated that both techniques produced 
similar postoperative analgesia. Since no prospective, randomized study has been conducted to 
compare these two techniques, the purpose of this study is to compare a single-shot fascial 
plane block technique plus IV lidocaine to a continuous nerve block technique. For the purpose 
of this study we chose two surgical models--VATS and major abdominal surgery--and ESP and 
QL blocks, respectively. 
Specific Aims 
This study will prospectively investigate the efficacy of continuous Erector Spinae Plane block 
(ESP) or Quadratus Lumborum block (QLB) versus the combination of single shot ESP or QLB 
plus postoperative intravenous (IV) lidocaine infusion for postoperative pain management in 
patients undergoing VATS and major abdominal surgery. The primary outcome measure will be 
total opioid medication consumption at 24 hr following the surgery, reported as total Morphine 
PO  equivalent in 24 hours after surgery. Secondary outcomes include opioid consumption at 48 
and 72 hours after surgery, pain scores at 6, 12, 24, 48, and 72 hours after surgery, total dose 
of local anesthetic administered at 12, 24, 48, and 72 hours after surgery - reported in (mg), 
serum lidocaine levels at 24, 48, and 72 hours postoperatively, total hospital length of stay from 
admission to discharge, patient satisfaction, and incidence of adverse events. Lastly, the cost of 
each technique will be assessed. 
 
Morphine equivalents will be calculated using ClinCalc - Equianalgesic dosage conversion 
calculator (22). Pain scores will be reported using the Numeric Pain Rating Scale, with 0 meaning 
no pain and 10 meaning worst possible pain (16). 
 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
All variables including opioid consumption, non-opioid analgesics, pain scores, local anesthetic 
medication consumption, serum lidocaine levels, and adverse events will be recorded on a case 
report form. 
Hypothesis 
There will be no difference in efficacy between the two groups. 
Study Design 
The study will be conducted as a prospective, randomized, open-label, non-inferiority, active-
comparator trial at the University of Pittsburgh Medical Center (UPMC) Shadyside Hospital. 
Institutional review board approval will be obtained before eligible patients are recruited and 
consented. The trial will be registered at www.clinicaltrials.gov before beginning recruitment. 
Recruitment 
Potential subjects will be recruited in the preoperative area of Shadyside hospital on the day of 
their scheduled thoracic or abdominal surgery. Patients who agree to participate in the trial will 
sign an IRB approved Informed Consent Form. Sixty patients are expected to be enrolled in this 
trial, with thirty in each group (group 1= continuous nerve block and group 2 = single block + IV 
infusion of lidocaine). Within each group, half of the patients will be scheduled for a unilateral 
VATS and half for major abdominal surgery. 
Randomization Process 
After obtaining a signed informed consent, participating patients will be randomized by computer 
generated random numbers to either the control group to receive continuous Erector Spinae 
Plane block (in the case of thoracic surgery) or continuous Quadratus Lumborum block (in the 
case of abdominal surgery), or the treatment group to receive single shot Erector Spinae Plane 
block (in the case of thoracic surgery) or single shot Quadratus Lumborum block (in the case of 
abdominal surgery) with postoperative intravenous lidocaine infusion. 
 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
Inclusion Criteria 
1. 18-90 years old 
2. Primary unilateral VATS or major abdominal surgery 
3. !"#$%&'()*$+,-./0$1$2&3. 
Exclusion Criteria 
1. Patient refusal 
2. Inpatient status at the time of surgery 
3. ASA class 4 or greater 
4. Pregnancy 
5. Non-English speaking or inability to participate in the study 
6. Patients with coagulopathy or on therapeutic anticoagulation 
7. Chronic steroid use 
8. Opioid use disorder 
9. Contraindication to performing any of the proposed blocks - active infection at the block site, 
systemic infection, allergy to local anesthetic medications 
10. Patients undergoing second surgery or urgent/emergent surgery 
11. Patients weighing < 50kg 
12. History of chronic pain and/or opioid tolerant 
13. Anticipated requirement for patient-controlled analgesia (PCA) 
14. Allergy or intolerance to any medication specified in the study protocol or postoperative pain 
management regimen 
15. Liver disease 
Treatment Groups 
Group 1, Continuous nerve blocks: A total of 30 subjects equally distributed to either  CESP 
for VATS , or CQL for major abdominal surgery. Patients in this group will receive 20ml 0.5% 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
ropivacaine per block performed after positioning of the needle followed by continuous 
perineural infusion of 0.25% lidocaine (10ml/hr) beginning in the post-anesthesia care unit 
(PACU) and continued for 72 hours or until 12 hours prior to patient discharge, whichever 
comes first, which is standard of care at this institution. 
Group 2, single nerve blocks plus IV lidocaine infusion: A total of 30 subjects equally 
distributed to either ESP for VATS, or QL for major abdominal surgery, will be included . 
Patients in this group will receive 20ml 0.5% ropivacaine per block after proper positioning of the 
Tuohy needle. Upon patient arrival in the recovery room a continuous infusion of IV lidocaine 50 
mg /hr  will be started and continued for 72 hours or until 12 hours prior to patient discharge, 
whichever comes first, which is standard of care at this institution. 
Block techniques 
I. 
Group 1= Continuous nerve blocks. 
A total of 30 subjects equally distributed to either CESP for VATS , or CQL for major 
abdominal surgery will be enrolled. 
A. Continuous ESP Block Approach: The patient will be positioned in seated position 
with side or sides to be blocked marked. The T5 spinous process will be identified by 
palpation starting with C7 and continuing caudad. C7 is the most prominent spinous 
process anatomically. The T5 spinous process will be marked with a marking pen. The 
block area will be cleaned using 2% chlorhexidine solution. The entire block procedure is 
performed under strict aseptic technique. An ultrasound probe covered in a sterile probe 
cover will be placed at the T5 spinous process in a cephalad to caudad orientation and 
moved lateral until the T5 transverse process is identified. 1-2ml of 1% lidocaine will be 
administered just above the ultrasound probe for local skin infiltration. An 18 gauge 
Tuohy needle will then be inserted in plane in a cephalad to caudad direction under 
ultrasound visualization until the tip of the needle touches the T5 transverse process. 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
The T5 transverse process is the anatomical target for this block. 20ml of 0.5% 
ropivacaine will then be injected using slow fractionated injection, aspirating every 5ml to 
ensure the needle tip is not intravascular. Local anesthetic spread in the appropriate 
plane will be confirmed with ultrasound. Once injection is complete, a 20 gauge 
nonstimulating catheter will be inserted through the Tuohy needle. Catheter tip 
placement will be confirmed with ultrasound. If bilateral blocks are to be performed, the 
procedure will then be repeated on the contralateral side.  
B. Continuous QL Block Approach: The patient will be positioned in lateral decubitus 
position with the side to be blocked facing up and the side or sides to be blocked 
marked. The block area will be cleaned using 2% chlorhexidine solution. The entire 
block procedure is performed under strict aseptic technique. An ultrasound probe 
covered in a sterile probe cover will be placed transversally between the iliac crest and 
the costal margin at the level of the anterior axillary line and the three muscles of the 
anterolateral abdominal wall (external oblique, internal oblique and transversus 
abdominis) will be identified. The probe will then be moved posteriorly until the 
transversus abdominis muscle (TAM) tapers off into its aponeurosis approximately at the 
level of the posterior axillary line, and posteriorly to this the intersection of the 
transversalis fascia with the lateral side of the QL muscle will be identified. An 18 gauge 
Tuohy needle will then be inserted in plane in an anterior to posterior direction until the 
tip of the needle is visualized at the intersection of the transversalis fascia with the lateral 
side of the QL muscle. The intersection of the transversalis fascia with the lateral side of 
the QL muscle is the anatomical target for this block. Once the initial injection of local 
anesthetic is complete, a 20 gauge nonstimulating catheter will be inserted through the 
Tuohy needle. Catheter tip placement will be confirmed with ultrasound. If bilateral 
blocks are to be performed, the patient will be repositioned, the area to be blocked will 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
be cleaned and prepared in a strict aseptic fashion as described above, and the 
procedure will then be repeated on the contralateral side.  
2. Group 2, Single shot nerve blocks with IV lidocaine: A total of 30 subjects equally 
distributed to either single-shot ESP for VATS , or single-shot QL for major abdominal surgery 
will be enrolled. A 22 gauge Tuohy needle will be used to perform these blocks. After the proper 
positioning of the needle 20ml of 0.5% ropivacaine plus, 4mg dexamethasone, plus 20mcg 
dexmedetomidine per injection site (30mcg if unilateral block only) will be deposited. In the 
recovery room an infusion of IV lidocaine at 50mg/hr for be initiated for 72 hours or until 12 
hours prior to patient discharge. 
A. 
Single Shot ESP Block with Postoperative IV Lidocaine Approach: The 
same technique described for the CESP will be used except that in this case a single 
ESP block will be used. 
B. 
Single Shot QL Block with Postoperative IV Lidocaine Approach: The same 
technique described for the CQL will be used except that a single QL block will be used. 
After the proper positioning of the 22 gauge Tuohy needle, 20ml of 0.5% ropivacaine, 4mg 
dexamethasone, and 30mcg dexmedetomidine (20mcg if bilateral blocks are to be performed) 
will then be injected using slow fractionated injection, aspirating every 5ml to ensure needle tip 
is not intravascular.  
Anesthetic Management 
Both treatment groups will receive the standard anesthetic technique and multimodal analgesic 
technique at our institution, including preoperative gabapentin 300mg PO and acetaminophen 
1000mg PO, intraoperative IV propofol infusion-based general anesthetic combined with sub-
anesthetic dose IV ketamine infusion, IV dexmedetomidine infusion, IV acetaminophen, and 
avoidance of intraoperative opioids. Postoperative pain management will also follow standard 
protocol, using IV hydromorphone (0.2-0.3 mg) and PO oxycodone (5-10 mg) on request by the 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
patient for moderate to severe pain (VAS >5), scheduled ketamine 20-50mg PO q 8hrs for 48 
hours, scheduled acetaminophen 1000mg IV or PO q 6hrs, scheduled gabapentin 100-300mg 
PO at bedtime, and dexmedetomidine infusion 0.2mcg/kg/hr IV for 24 hours if the patient is 
located in the Intensive Care Unit. 
Data Collection and Outcome Measures 
Once the patient has signed the informed consent document, they will be randomized to receive 
CESP or CQLB, or SESP or SQLB with postoperative IV lidocaine infusion. The person 
administering the block and the patient will be unblinded. The outcome assessors will be blinded 
to the treatment group allocation. The primary outcome measure is total opioid medication 
consumption, reported as total Morphine equivalent in 24 hours after surgery. Secondary 
outcomes include opioid consumption at 48 and 72 hours after surgery, pain scores at 6, 12, 24, 
48, and 72 hours after surgery, total dose of local anesthetic administered at 12, 24, 48, and 72 
hours after surgery - reported in (mg), serum lidocaine levels at 24, 48, and 72 hours 
postoperatively, total hospital length of stay from admission to discharge, and incidence of 
adverse events - nausea and vomiting requiring treatment, hypotension, and bradycardia or 
tachycardia. Opioid medication consumption, pain scores, local anesthetic medication 
consumption, serum lidocaine levels, and adverse effects will be recorded on worksheets 
included in patient research folders, with each study participant having their own research folder 
identified only by randomly assigned patient study number. 
Statistics 
Demographics will be presented as mean ± SD. Pain and opioid consumption data will be 
presented as median (75% confidence interval). This study is designed as a non-inferiority trial. 
All continuous variables will be compared between the two groups by Wilcoxon rank sum test 
and dichomatous variables will be compared by Chi-square test. P < 0.05 will be considered 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
statistically significant. SPSS 12.0 software will be utilized for statistical analysis. Intention to 
treat analysis will be utilized for this study. 
 
 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
 
References 
 
1. Adhikary SD, Pruett A, Forero M et al. Erector spinae plane block as an alternative to 
epidural analgesia for post-operative analgesia following video-assisted thoracoscopic 
surgery: A case study and a literature review on the spread of local anaesthetic in the erector 
spinae plane. Indian J Anaesth. 2018 Jan;62(1):75-78.  
2. Akerman M, Pejčić N, Veličković I. A Review of the Quadratus Lumborum Block and ERAS. 
Front Med (Lausanne). 2018;5:44. 
3. Aksu C, Şen MC, Akay MA, Baydemir C, Gürkan Y. Erector Spinae Plane Block vs 
Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, 
prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. 
4. Antony S, Gurnaney H, Ganesh A. Pediatric Ambulatory Continuous Peripheral Nerve 
Blocks. Anesthesiol Clin. 2018 Sep;36(3):455-465. 
5. Baidya DK, Khanna P, Maitra S. Analgesic efficacy and safety of thoracic paravertebral and 
epidural analgesia for thoracic surgery: a systematic review and meta-analysis. Interact 
Cardiovasc Thorac Surg. 2014 May;18(5):626-35.  
6. Bang S, Chung K, Chung J et al. The erector spinae plane block for effective analgesia after 
lung lobectomy: Three cases report. Medicine (Baltimore). 2019 Jul;98(29):e16262.  
7. Bjelland TW, Yates TGR, Fagerland MW, Frøyen JK, Lysebråten KR, Spreng UJ. Quadratus 
lumborum block for postoperative analgesia after full abdominoplasty: a randomized 
controlled trial. Scand J Pain. 2019 May 21;. 
8. Chin KJ. Thoracic wall blocks: From paravertebral to retrolaminar to serratus to erector 
spinae and back again - A review of evidence. Best Pract Res Clin Anaesthsiol. 2019 
Mar;33(1):67-77.  
9. Chutkowski R, Wódarski B, Krzęczko P, Malec-Milewska M. Continuous Quadratus 
Lumborum Block (QLB) for postoperative recurrent and chronic pain. Series of case reports. 
Anaesthesiol Intensive Ther. 2018;50(4):319-320. 
10. Dam M, Hansen CK, Poulsen TD, Azawi NH, Wolmarans M, Chan V, Laier GH, Bendtsen 
TF, Børglum J. Transmuscular quadratus lumborum block for percutaneous nephrolithotomy 
reduces opioid consumption and speeds ambulation and discharge from hospital: a single 
centre randomised controlled trial. Br J Anaesth. 2019 Aug;123(2):e350-e358. 
11. Dewinter G, Coppens S, Van de Velde M, D'Hoore A, Wolthuis A, Cuypers E, Rex S. 
Quadratus Lumborum Block Versus Perioperative Intravenous Lidocaine for Postoperative 
Pain Control in Patients Undergoing Laparoscopic Colorectal Surgery: A Prospective, 
Randomized, Double-blind Controlled Clinical Trial. Ann Surg. 2018 Nov;268(5):769-775. 
12. El-Boghdadly K, Elsharkawy H, Short A, Chin KJ. Quadratus Lumborum Block 
Nomenclature and Anatomical Considerations. Reg Anesth Pain Med. 2016 Jul-
Aug;41(4):548-9. 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
13. Eldemrdash AM, Abdelzaam EM. By Ultrasonic-Guided Erector Spinae Block, Thoracic 
Paravertebral Block versus Serratus Anterior Plane Block by Articaine with Adrenaline 
during Breast Surgery with General Anesthesia: A Comparative Study of Analgesic Effect 
Post-Operatively: Double Blind Randomized, Controlled Trial. Open J Anesthesiol. 2019, 
9:68-82.  
14. Elsharkawy H, Ahuja S, DeGrande S, Maheshwari K, Chan V. Subcostal approach to 
anterior quadratus lumborum block for pain control following open urological procedures. J 
Anesth. 2019 Feb;33(1):148-154. 
15. Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical 
Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. 
16. Equivalent Opioid Calculator – Equianalgesic dosage conversion calculator. ClinCalc, 
ClinCalc LLC 2019, https://clincalc.com/Opioids/.  
17. Fang B, Wang Z, Huang X. Ultrasound-guided preoperative single-dose erector spinae 
plane block provides comparable analgesia to thoracic paravertebral block following 
thoracotomy: a single center randomized controlled double-blind study. Ann Transl Med. 
2019 Apr;7(8):174.  
18. Forero M, Adhikary SD, Lopez H et al. The Erector Spinae Plane Block: A Novel Analgesic 
Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7.  
19. Fujimoto H, Irie T, Mihara T, Mizuno Y, Nomura T, Goto T. Effect of posterior quadratus 
lumborum blockade on the quality of recovery after major gynaecological laparoscopic 
surgery: A randomized controlled trial. Anaesth Intensive Care. 2019 Mar;47(2):146-151. 
20. Goldberg SF, Pozek JJ, Schwenk ES, Baratta JL, Beausang DH, Wong AK. Practical 
Management of a Regional Anesthesia-Driven Acute Pain Service. Adv Anesth. 
2017;35(1):191-211. 
21. Gómez-Ríos MÁ, Gómez-Ríos D. Continuous bilateral quadratus lumborum block after 
abdominal surgery. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun;33(2):261-262. 
22. Haefeli M, Elfering A. Pain assessment. Eur Spine J (2006) 15: S17–S24.  
23. Ilfeld BM. Continuous Peripheral Nerve Blocks: An Update of the Published Evidence and 
Comparison With Novel, Alternative Analgesic Modalities. Anesth Analg. 2017 
Jan;124(1):308-335. 
24. Kelava M, Anthony D, Elsharkawy H. Continuous Erector Spinae Block for Postoperative 
Analgesia After Thoracotomy in a Lung Transplant Recipient. J Cardiothorac Vasc Anesth. 
2018 Oct;32(5):e9-e11. 
25. Kumar GD, Gnanasekar N, Kurhekar P, Prasad TK. A Comparative Study of Transversus 
Abdominis Plane Block versus Quadratus Lumborum Block for Postoperative Analgesia 
following Lower Abdominal Surgeries: A Prospective Double-blinded Study. Anesth Essays 
Res. 2018 Oct-Dec;12(4):919-923. 
26. Lee AJ, Yabes JG, Hale N, Hrebinko RL, Gingrich JR, Maranchie JK, Fam MM, Turner I I 
RM, Davies BJ, Ben-David B, Jacobs BL. The comparative effectiveness of quadratus 


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
lumborum blocks and paravertebral blocks in radical cystectomy patients. Can J Urol. 2018 
Apr;25(2):9255-9261. 
27. MacFater WS, Rahiri JL, Lauti M, Su'a B, Hill AG. Intravenous lignocaine in colorectal 
surgery: a systematic review. ANZ J Surg. 2017 Nov;87(11):879-885. 
28. Masic D, Liang E, Long C, Sterk EJ, Barbas B, Rech MA. Intravenous Lidocaine for Acute 
Pain: A Systematic Review. Pharmacotherapy. 2018 Dec;38(12):1250-1259. 
29. Munoz F, Cubillos J, Bonilla AJ et al. Erector spinae plane block for postoperative analgesia 
in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882.  
30. Nguyen NL, Kome AM, Lowe DK, Coyne P, Hawks KG. Intravenous Lidocaine as an 
Adjuvant for Pain Associated with Sickle Cell Disease. J Pain Palliat Care Pharmacother. 
2015;29(4):359-64. 
31. Njathi CW, Johnson RL, Laughlin RS, Schroeder DR, Jacob AK, Kopp SL. Complications 
After Continuous Posterior Lumbar Plexus Blockade for Total Hip Arthroplasty: A 
Retrospective Cohort Study. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):446-450. 
32. Ökmen K, Ökmen BM. Ultrasound-guided anterior quadratus lumborum block for 
postoperative pain after percutaneous nephrolithotomy: randomized controlled trial. Korean 
J Anesthesiol. 2019 Sep 2;. 
33. Öksüz G, Bilal B, Gürkan Y, Urfalioğlu A, Arslan M, Gişi G, Öksüz H. Quadratus Lumborum 
Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal 
Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-
679. 
34. Rao Kadam V, Ludbrook G, van Wijk RM, Hewett PJ, Moran JL, Thiruvenkatarajan V, 
Williams PJ. Comparison of ultrasound-guided transmuscular quadratus lumborum block 
catheter technique with surgical pre-peritoneal catheter for postoperative analgesia in 
abdominal surgery: a randomised controlled trial. Anaesthesia. 2019 Aug 11;. 
35. Restrepo-Garces CE, Chin KJ, Suarez P et al. Bilateral Continuous Erector Spinae Plane 
Block Contributes to Effective Postoperative Analgesia After Major Open Abdominal 
Surgery: A Case Report. A A Case Rep. 2017 Dec 1;9(11):319-321.  
36. Saporito A, Anselmi L, Sturini E, Borgeat A, Aguirre JA. Is outpatient continuous regional 
analgesia more effective and equally safe than single-shot peripheral nerve blocks after 
ambulatory orthopedic surgery?. Minerva Anestesiol. 2017 Sep;83(9):972-981. 
37. Shaaban M, Esa WA, Maheshwari K, Elsharkawy H, Soliman LM. Bilateral Continuous 
Quadratus Lumborum Block for Acute Postoperative Abdominal Pain as a Rescue After 
Opioid-Induced Respiratory Depression. A A Case Rep. 2015 Oct 1;5(7):107-11. 
38. Shanthanna H, Moisuik P, O’Hare T et al. Survey of Postoperative Regional Analgesia for 
Thoracoscopic Surgeries in Canada. J Cardiothorac Vasc Anesth. 2018 Aug;32(4):1750-
1755.  
39. Short HL, Kamalanathan K. Has analgesia changed for lung resection surgery? 
Anaesthesia. 2018 Apr;73(4):412-416.  


Evaluating the efficacy of continuous nerve block vs combination of single-injection block plus 
intravenous lidocaine for postoperative pain. 
 
40. Singh S, Chowdhary NK. Erector spinae plane block an effective block for post-operative 
analgesia in modified radical mastectomy. Indian J Anaesth. 2018 Feb; 62(2): 148–150. 
41. Tamura T, Yokota S, Ito S, Shibata Y, Nishiwaki K. Local anesthetic spread into the 
paravertebral space with two types of quadratus lumborum blocks: a crossover volunteer 
study. J Anesth. 2019 Feb;33(1):26-32. 
42. Tsui BCH, Fonseca A, Munshey F. The erector spinae plane (ESP) block: A pooled review 
of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. 
43. van der Wal SE, van den Heuvel SA, Radema SA, van Berkum BF, Vaneker M, Steegers 
MA, Scheffer GJ, Vissers KC. The in vitro mechanisms and in vivo efficacy of intravenous 
lidocaine on the neuroinflammatory response in acute and chronic pain. Eur J Pain. 2016 
May;20(5):655-74. 
44. Wang HJ, Liu Y, Ge WW et al. Comparison of ultrasound-guided serratus anterior plane 
block and erector spinae plane blockperioperatively in radical mastectomy. Zhonghua Yi 
Xue Za Zhi. 2019 Jun 18;99(23):1809-1813. 
45. Weibel S, Jelting Y, Pace NL, Helf A, Eberhart LH, Hahnenkamp K, Hollmann MW, 
Poepping DM, Schnabel A, Kranke P. Continuous intravenous perioperative lidocaine 
infusion for postoperative pain and recovery in adults. Cochrane Database Syst Rev. 2018 
Jun 4;6:CD009642. 
46. Yayik AM, Ahiskalioglu A, Alici HA, Celik EC, Cesur S, Ahiskalioglu EO, Demirdogen SO, 
Karaca O, Adanur S. Less painful ESWL with ultrasound-guided quadratus lumborum block: 
a prospective randomized controlled study. Scand J Urol. 2019 Sep 9;:1-6. 
47. Yeung JH, Gates S, Naidu BV et al. Paravertebral block versus thoracic epidural for patients 
undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2:CD009121. 
48. Yousef NK. Quadratus Lumborum Block versus Transversus Abdominis Plane Block in 
Patients Undergoing Total Abdominal Hysterectomy: A Randomized Prospective Controlled 
Trial. Anesth Essays Res. 2018 Jul-Sep;12(3):742-747. 
49. Zhu M, Qi Y, He H, Lou J, Pei Q, Mei Y. Analgesic effect of the ultrasound-guided subcostal 
approach to transmuscular quadratus lumborum block in patients undergoing laparoscopic 
nephrectomy: a randomized controlled trial. BMC Anesthesiol. 2019 Aug 14;19(1):154. 
50. Zhu Q, Li L, Yang Z, Shen J, Zhu R, Wen Y, Cai W, Liu L. Ultrasound guided continuous 
Quadratus Lumborum block hastened recovery in patients undergoing open liver resection: 
a randomized controlled, open-label trial. BMC Anesthesiol. 2019 Feb 18;19(1):23. 
 

ICF_001.pdf: 
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Department of Anesthesiology
CONSENT TO ACT AS A PARTICIPANT IN A RESEARCH STUDY
TITLE: A Prospective, Randomized, Open-Label, Active-Comparator, Non-
Inferiority study of the efficacy of Continuous nerve block vs Single block plus 
Intravenous Lidocaine for postoperative pain.
PRINCIPAL INVESTIGATOR:
Jeremy Kearns, MD
UPMC Shadyside
5230 Centre Avenue
Pittsburgh, Pennsylvania 15232
412.623.6904
FACULTY MENTOR: 
Jacques E. Chelly, MD, PhD, MBA
UPMC Shadyside
5230 Centre Avenue
Pittsburgh, Pennsylvania 15232
412.623.6904
CO-INVESTIGATORS:
David Bartlett, MD
Bruce Ben-David, MD     
Mohammad Choudry, MD
Neil Christie, MD
Rajeev Dhupar, MD
Matthew Holtzman, MD
Sharad Khetarpal, MD     
Olugbenga Okusanya, MD
James Pingpank, MD
Carl Rest, MD
Inderpal Sarkaria, MD
Hung Tran, MD
Anna Uskova, MD
Gabriel Wilner, MD
Zahraa Majeed, M.B.Ch.B, MBA, MS
SOURCE of SUPPORT:
None


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Why is this research being done?
We recommend a multimodal approach to pain management for primary abdominal 
surgeries that includes regional anesthesia (nerve blocks). In this institution, we 
routinely use a type of nerve block called the Quadratus Lumborum block) as standard-
of-care. This block has been shown to give effective pain relief after theis type of 
surgery. It is easy to perform and low risk, as the local anesthetic is injected far away 
from sensitive structures such as the spinal cord and the lung. It is also common 
practice at this hospital to perform a continuous nerve block, where a small catheter is 
left at the nerve block site in order to give an infusion of local anesthetic and extend the 
block length after surgery. However, continuous blocks have some rare risks and 
limitations, including catheter dislodgement, movement, kinking and leaking at the site, 
increased risk of bleeding, especially when using blood thinning medications, and 
infection. They are also quite a bit more expensive than single nerve blocks due to 
higher supply and disposal costs. 
The multimodal pain medication regimen that is used as standard-of-care at this 
hospital, and that everyone in this study will receive, includes the following medicines: 
gabapentin (100-300mg by mouth nightly), acetaminophen (1000mg by mouth every six 
hours), IV ketamine (5 mg/h, with escalation up to 10 mg/h if needed, for up to 48 
hours), and (only if you are in the Intensive Care Unit) dexmedetomidine (0.2mg/kg/hour 
IV for 24 hours). Oral and IV opioids (oxycodone 5-10mg by mouth, hydromorphone 
0.2-0.3mg IV) will be available on request for moderate to severe pain (pain level > 
5/10).
Intravenous (IV) lidocaine (local anesthetic) is another medication that is very safe and 
has been shown to provide pain relief after surgery. It is thought that doing a single 
nerve block followed by an intravenous lidocaine infusion after surgery may provide the 
same benefits of a continuous nerve block while avoiding their risks and increased 
costs. However, there are no prospective studies comparing these two techniques 
directly. Therefore, the purpose of this study is to show that a single injection nerve 
block together with postoperative IV lidocaine is not worse than the standard-of-care 
continuous nerve block for primary thoracic and abdominal surgeries.
Who is being asked to take part in this research study?
You are being invited to participate in this research study because you will undergo 
primary one-sided thoracic or major abdominal surgery. People being invited to 
participate must be over 18 years of age.
What procedures will be performed for research purposes?
Screening Procedures:
There are no specific screening tests or procedures for this research study. Your 
medical records will be examined by your anesthesiologist to determine your eligibility 
for the study. 
Procedures:
If you qualify to take part in this research study, you will undergo the procedures listed 


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below:
After you sign an informed consent form, you will be enrolled into the study. You will be 
randomized, or randomly assigned, in a 1:1 ratio (similar to flipping a coin) via a 
computer-generated number system, into either the control or intervention group. The 
control group will receive the hospital’s standard of care intervention as indicated by the 
accepted protocol for major abdominal surgery, which consists of a multimodal pain 
management regimen, including continuous Quadratus Lumborum block. The 
intervention group will receive single injection Quadratus Lumborum block plus 
postoperative IV Lidocaine infusion, and will also receive a multimodal pain 
management regimen. Nerve block procedures will take approximately 10-20 minutes to 
complete. All nerve block procedures will be performed under strict aseptic (clean) 
technique using sterile equipment and gloves.
For the Quadratus Lumborum block, you will be positioned on the side with the side to 
be blocked facing up, and this side will be marked. An ultrasound probe will be used to 
identify the muscle layers on the side of the trunk just above the hip bone. After cleaning 
the area with sterile solution and numbing the skin, a needle will be placed between the 
appropriate muscle and tissue layers under real-time ultrasound visualization, and once 
correct placement is confirmed the local anesthetic medication will be injected.
If you receive a continuous nerve block, once the initial injection is complete a small 
catheter (about the size of fishing line) will be inserted at the site and confirmed to be in 
the correct place using ultrasound. It will then be taped to the skin underneath a sterile 
dressing. If you receive a single block, the procedure will be complete once the injection 
is finished--there will be no catheter placement.
You, as well as your doctors and nurses, will know which group you are in.  However, 
the research team will not know which group you are participating in while on study.
Monitoring/Follow-up Procedures
Pain Level: Pain level will be measured at 6, 12, 24, 48, and 72 hours after surgery. 
Pain level will be measured on a scale of 0 to 10, with 0 meaning no pain and 10 
meaning the worst pain imaginable.
Pain Medications Consumption: total opioid pain medications given in 24, 48, and 72 
hours after surgery will be collected. Total amount of local anesthetic medicine given in 
24, 48, and 72 hours after surgery and how it was administered (IV or via nerve block) 
will be collected. 
Serum Lidocaine Levels: the amount of lidocaine (local anesthetic) in your blood will be 
measured at 24, 48, and 72 hours after surgery. Each measurement will involve a blood 
draw of one teaspoon or less that will be performed by properly credentialed nurses or 
phlebotomy staff at UPMC Shadyside.
Length of Hospital Stay – Total length of hospital stay will be collected.


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 Adverse effects – any incidence of adverse effects like nausea, vomiting, low blood 
pressure, and slow or fast heart rate will be collected.
What are the possible risks, side effects, and discomforts of this research study?
There are risks associated with your surgery, anesthesia, and hospitalization. These 
risks will be discussed with you by your surgeon and anesthesiologist and are 
independent of your participation in this research study. 
Risks associated with Quadratus Lumborum block:
1.
Pain or bruising at site of nerve block
2.
Bleeding
3.
Infection
4.
Nerve damage resulting in persistent numbness, tingling, muscle weakness or 
paralysis
5.
Local Anesthetic Toxicity
Risks associated with Intravenous Lidocaine infusion:
1.
General fatigue, dizziness, or headache
2.
Local Anesthetic Toxicity
Risks associated with randomization:
Since the treatments will be assigned randomly, the process of randomization will 
necessarily carry the associated risks and benefits of the specific type of treatment to be 
used here.  
Risks associated with the multimodal pain management regimen will be discussed when 
you receive
anesthesia consent for the standard of care surgery procedure.
Your medical record will be accessed by the study team. Some of the information 
reviewed in the medical record include medical history, surgical and anesthesia record, 
medication record, and pain scores.  All of your medical record and study-related 
information will be considered protected health information and will be kept confidential 
per HIPAA privacy act. There is, however, a possibility of breach of confidentiality. That 
is, in very rare cases, people not associated with this research study may inadvertently 
see your identifiable research results. We will do everything in our power to prevent this 
from happening by keeping all research records in locked files and identify all 
specimens and medical information by a research record number, rather than by your 
name or social security number. The codebook containing your name and number will 
be kept secure by the Study Team.
A description of this clinical trial will be available on http://www.clinicaltrials.gov, as 
required by US Law. This website will not include information that can identify you. At 
most, the website will include a summary of the results. You can search this website at 
any time.


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You can speak with your anesthesiologist if you have any questions or concerns 
regarding the implications and frequencies of each risk.
What are possible benefits from taking part in this study?
You will not directly benefit from participating in this study.
What treatments or procedures are available if I decide not to take part in this 
research study?
If you decide not to take part in this research study, you will receive the standard of care 
anesthesia and post-operative care dictated by this institution. 
If I agree to take part in this research study, will I be told of any new risks that may be 
found during the course of the study?
You will be promptly notified if, during the conduct of this research study, any new 
information develops which may cause you to change your mind about continuing to 
participate.
Will my insurance provider or I be charged for the costs of any procedures performed as 
part of this research study?
Some of the services you will receive during this study are considered to be “routine 
clinical services” that you would have even if you were not in the study. These include 
surgery, standard of care anesthesia, which may include a nerve block, and multimodal 
pain management. These services will be billed to your health insurance company or 
you, if you do not have health insurance. You will not be charged for study activities that 
are not part of “routine clinical services” such as serum lidocaine level measurement.
You will be responsible for paying any deductibles, co-payments or co-insurance that 
are a normal part of your health insurance plan. 
You may want to get more detailed information about what “routine clinical services” 
your health insurance is likely to pay for.  Talk to a member of the study staff and/or a 
UPMC financial counselor to get more information.  
Alternative treatments 
If you do not participate in this study, you will likely still participate in the standard 
protocol of post-operative care at UPMC facilities and will receive a nerve block 
according to your anesthesiologist’s preference.
Will I be paid if I take part in this research study?
You will not receive any payment for participating in this research study.
Who will pay if I am injured as a result of taking part in this study?
University of Pittsburgh researchers and their associates who provide services at UPMC 
(UPMC) recognize the importance of your voluntary participation in their research 
studies.  These individuals and their staffs will make reasonable efforts to minimize, 
control, and treat any injuries that may arise as a result of this research.  If you believe 
that you are injured as a result of the research procedures being performed, please 
contact immediately the Principal Investigator listed on the first page of this form. 
Emergency medical treatment for injuries solely and directly related to your participation 
in this research study will be provided to you by the hospitals of UPMC.  It is possible 


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that UPMC may bill your insurance provider for the costs of this emergency treatment, 
but none of these costs will be charged directly to you.  If your research-related injury 
requires medical care beyond this emergency treatment, you will be responsible for the 
costs of this follow-up care unless otherwise specifically stated below.  There is no plan 
for monetary compensation. You do not, however, waive any legal rights by signing this 
form.
Who will know about my participation in this research study?
Any information about you obtained from this research will be kept as confidential 
(private) as possible.  All records related to your involvement in this research study will 
be stored in a locked file cabinet. Your identity on these records will be indicated by a 
case number rather than by your name. The information linking these case numbers 
with your identity will be kept separate from the research records. You will not be 
identified by name in any publication of the research results. We will attempt to preserve 
your medical record and participation in this study as confidentially as possible, but 
breach of confidentiality is a risk of participation. 
In the future, the investigators may decide to share data with other investigators 
both within and outside of this institution. If that were to occur, we would de-
identify all of the information prior to sharing any data in this way.
Will this research study involve the use or disclosure of my identifiable medical 
information?
This research study will involve the recording of past, current and/or future identifiable 
(pertaining to only you) medical information from your hospital and/or other health care 
provider (e.g. physician office) records.  This information that will be recorded will be 
limited to diagnostic information, lab results, medications, and medical history.  The 
information will be used to determine your eligibility for this study and to follow your care 
once you are enrolled in the study.
This research study will result in identifiable information that will be placed into your 
medical records held at UPMC and the UPMC Cancer Centers.  The nature of the 
identifiable information resulting from your participation in this research study that will be 
recorded in your medical record includes response to study treatment including adverse 
events (side effects).
Who will have access to identifiable information related to my participation in this 
research study?
In addition to the investigators listed on the first page of this authorization (consent) 
form and their research staff, the following individuals will or may have access to 
identifiable information (which may include your identifiable medical information) related 
to your participation in this research study: 
Authorized representatives of the University of Pittsburgh Office of Research 
Protections may review your identifiable research information (which may include 
your identifiable medical information) for the purpose of monitoring the 
appropriate conduct of this research study. 
Authorized representatives of the study team, who are also part of the 


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Department of Anesthesiology and the Acute Interventional Perioperative Pain 
Service, will review and/or obtain identifiable information (which may include your 
identifiable medical information) related to your participation in this research 
study for the purpose of monitoring the accuracy and completeness of the 
research data and for performing required scientific analyses of the research 
data. 
Authorized representatives of the UPMC hospitals or other affiliated health care 
providers may have access to identifiable information (which may include your 
identifiable medical information) related to your participation in this research 
study for the purpose of (1) fulfilling orders, made by the investigators, for 
hospital and health care services (e.g., laboratory tests, diagnostic procedures) 
associated with research study participation; (2) addressing correct payment for 
tests and procedures ordered by the investigators; and/or (3) for internal hospital 
operations (i.e. quality assurance).
In unusual cases, the investigators may be required to release identifiable 
information (which may include your identifiable medical information) related to 
your participation in this research study in response to an order from a court of 
law.  If the investigators learn that you or someone with whom you are involved is 
in serious danger or potential harm, they will need to inform, as required by 
Pennsylvania law, the appropriate agencies.
For how long will the investigators be permitted to use and disclose identifiable 
information related to my participation in this research study?
The investigators may continue to use and disclose, for the purposes described above, 
identifiable information (which may include your identifiable medical information) related 
to your participation in this research study for an indefinite period of time. Per University 
of Pittsburgh policy all research records must be maintained for at least 7 years following 
final reporting or publication of a project.
May I have access to my medical information that results from my participation in 
this research study?
In accordance with the UPMC Notices of Privacy Practices document that you have 
been provided, you are permitted access to information (including information resulting 
from your participation in this research study) contained within your medical records 
filed with your health care provider.
Is my participation in this research study voluntary?
Your participation in this research study is completely voluntary. Whether or not you 
provide your consent for participation in this research study will have no effect on your 
current or future relationship with the University of Pittsburgh.  Whether or not you 
provide your consent for participation in this research study will have no effect on your 
current or future medical care at a UPMC hospital or affiliated health care provider or 
your current or future relationship with a health care insurance provider.
Your anesthesiologist is involved as an investigator in this research study.  As both your 
doctor and a research investigator, s/he is interested both in your medical care and the 
conduct of this research study.  Before agreeing to participate in this research study, or 
at any time during your study participation, you may discuss your care with another 


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doctor who is not associated with this research study.  You are not under any obligation 
to participate in any research study offered by your anesthesiologist.
May I withdraw, at a future date, my consent for participation in this research 
study?
You may withdraw, at any time, your consent for participation in this research study. 
Any identifiable research or medical information recorded for, or resulting from, your 
participation in this research study prior to the date that you formally withdrew your 
consent may continue to be used and disclosed by the investigators for the purposes 
described above.
To formally withdraw your consent for participation in this research study you should 
provide a written and dated notice of this decision to the principal investigator of this 
research study at the address listed on the first page of this form.
Your decision to withdraw your consent for participation in this research study will have 
no effect on your current or future relationship with the University of Pittsburgh.  Your 
decision to withdraw your consent for participation in this research study will have no 
effect on your current or future medical care at a UPMC hospital or affiliated health care 
provider or your current or future relationship with a health care insurance provider.
If you decide to withdraw from study participation after you have received the study 
drug, no study assessments will be done after your withdrawal.
If I agree to take part in this research study, can I be removed from the study 
without my consent?
It is possible that you may be removed from the research study by the researchers if, for 
example, you have an unexpected change, complication in your anesthesia or surgery or 
serious adverse reaction. If you are withdrawn from participation in this research study, 
you will still be treated for your post-surgical pain. Please consult your surgeon or 
anesthesiologist if you have any further concerns. 


University of Pittsburgh STUDY19100057    Effective: 12/7/2021    Expires: 12/6/2022
                                                                          Page 9 of 10                                          
VOLUNTARY CONSENT
The above information has been explained to me and all of my current questions have 
been answered. I understand that I am encouraged to ask questions about any aspect of 
this research study during the course of this study, and that such future questions will be 
answered by a qualified individual or by the principal investigator listed on the first page 
of this consent document at the telephone number given. I understand that I may always 
request that my questions, concerns or complaints be addressed by a listed investigator.  
I understand that I may contact the Human Subjects Protection Advocate of the IRB 
Office, University of Pittsburgh (1-866-212-2668) to discuss problems, concerns, and 
questions; obtain information; offer input; or discuss situations in the event that the 
research team is unavailable.  
By signing this form, I agree to participate in this research study and to authorize Dr. 
Kearns and the members of his research team to access my medical records and extract 
research data from them, as described in this document. Dr. Gabriel Wilner or a qualified 
member of his research team will sign this consent and a copy of this consent form will 
be given to me. Also, I further certify that no research component of this protocol was 
begun until after the consent form was signed.
____________________________________
            
Participant’s Signature
 ____________________________________
____________
Printed Name of Participant
Date


University of Pittsburgh STUDY19100057    Effective: 12/7/2021    Expires: 12/6/2022
                                                                          Page 10 of 10                                          
CERTIFICATION of INFORMED CONSENT
I certify that I have explained the nature and purpose of this research study to the above-
named individual(s), and I have discussed the potential benefits and possible risks of 
study participation. Any questions the individual(s) have about this study have been 
answered, and we will always be available to address future questions as they arise.  I 
further certify that no research component of this protocol was begun until after this 
consent form was signed.
___________________________________
________________________
Printed Name of Person Obtaining Consent
Role in Research Study
__________________________________
____________
Signature of Person Obtaining Consent
Date