Clinical trial NCT05480111
Conditions: Pain, Postoperative
Keywords: laparoscopy hysterectomy
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2022-09-07; Completion date: 2023-04-07
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare quality of recovery as well as peri-operative systemic opiates use and pain scores in patients undergoing laparoscopic or robotic hysterectomy when local anesthetic versus Quadratus Lumborum nerve block (QL-2) is added to the standard pain management.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Local anesthesia at incision site intervention 2: Sham QL intervention 3: Sham Local intervention 4: QL
Intervention descriptions: intervention 1: 20 ml of 0.25% Bupivacaine will be given at incision site intervention 2: 20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia intervention 3: 20 mls of normal saline given at incision site intervention 4: QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia

Protocol documents:
Prot_SAP_000.pdf: 
IRB NUMBER: HSC-MS-22-0158 
IRB APPROVAL DATE: 07/18/2022 
Page 1 of 19 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy: A 
Blinded, Randomized Controlled Trial 
 
NCT05480111 
 
Version Date: 07/18/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


IRB NUMBER: HSC-MS-22-0158 
IRB APPROVAL DATE: 07/18/2022 
Page 1 of 19 
 
Protocol Title: The Role of Regional Blocks Following Minimally Invasive 
Hysterectomy: A blinded Randomized Controlled Trial 
 
Principal investigator: Randa Jalloul, MD (Gynecology Faculty) 
 
Co-Investigators: Nadia Hernandez, MD (Anesthesia) 
Sara Guzman, MD (Anesthesia) 
 
Statistician: Claudia Pedroza 
 
Study coordinator: Sunbola Ashimi, PhD 
 
Research Assistant: Mason Hui 
 
Population: 76 female patients undergoing Minimally Invasive Hysterectomy 
 
Number of sites: One site MHH-TMC 
 
Study duration: 2 years 
 
Subject duration: 6 weeks 
 
 
General Information (PICO) 
This is a single center double blind randomized controlled trial assessing the efficacy of 
the addition of anesthetic blocks in reducing systemic opiates use (PO and IV) and 
lowering pain scores when added to a standardized ERAS (Enhanced Recovery After 
Surgery) protocol bundle, in patients undergoing minimally invasive hysterectomy at 
MMH-TMC. 
We seek to compare the efficacy of two interventions: 
• Local anesthesia with sham QL block. 
• Quadratus lumborum block (QL block) with sham local. 
Both types of anesthetics options (local anesthetics and QL blocks) are used as usual 
care and depend on surgeon preference without strong evidence of efficacy. 
Our main objective is to assess which intervention best improves the quality of recovery, 
reduces systemic opiates use (PO and IV) and lowers pain scores in patients 
undergoing minimally invasive hysterectomy at 24 hours. 
 
Background Information 
 
In 2017, the CDC reported 50,000 deaths related to Opioid overdose in the United 
States. Prescription opioids are involved in 40% of these deaths (1). Post-operative 
opioid prescriptions may contribute to this epidemic by increasing patients' risk of opioid 
dependency and overdose (2-7). Therefore, effective interventions are needed to 
address this problem, such as reducing opioid use intra-operatively and in the 
immediate postoperative period. 


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Page 2 of 19 
 
Several adjuvant regional analgesic blocks have shown to effectively provide analgesia 
for surgery-associated pain following abdominal surgery (8). 
 
However conflicting results have been found regarding their use in laparoscopy. Many 
clinical trials tested the TAP block (9-12) while others tested the QL block (13, 14). (15) 
 
QL blocks have been proven to be effective in reducing morphine consumption after 
cesarean sections(16, 17), however this was not noted after laparoscopic colorectal 
surgery (18). 
Conflicting results again have been demonstrated in a couple of RCTs after 
laparoscopic gynecologic surgery (19-25). 
Results of an RCT including 120 patients undergoing cholecystectomy, demonstrated 
that TAP and QL blocks similarly reduced postoperative pain scores and analgesia 
consumption, with high patient satisfaction. However, subcostal TAP block could be 
considered preferable to QL block because it can be applied easily and in a shorter time 
(22). 
 
The UT faculty at MHH usually offer QL blocks to patients presenting for minimally 
invasive hysterectomy while counseling about possible benefit in reducing pain during 
recovery. If a patient is not offered a QL blovk or declines, the surgeon will give local 
anesthetic at the port site. 
 
While local anesthetic at the port site is given by the gynecologist, (QL) blocks are given 
by the regional anesthesia team. QL blocks are done under ultrasound guidance to 
improve efficacy and reduce complications. 
 
Local anesthesia is given as per usual care: Each trocar site is infiltrated with 3 mL of 
the 0.25% marcaine in a diamond-shape pattern below and above the fascia. 
 
The quadratus lumborum block (QL 2) is the newest modality, involves injection of 
local anesthesia in a fascial place formed partly by the posterior surface of the 
quadratus lumborum muscle. 
 
It is described to cover many dermatomes (range from T4 to L1) with cephalad and 
posterior spread to provide both visceral and somatic analgesia likely due to 
paravertebral and possibly epidural spread and can last up to 24 hours (19-21). It is 
speculated that the use of QL block will reduce the use of systemic opiates within at 
least the first 24-36 hours. 
 
 
 
 
Figure 1 


IRB NUMBER: HSC-MS-22-0158 
IRB APPROVAL DATE: 07/18/2022 
Page 3 of 19 
 
 
 
Figure 2 
 
 
QL blocks however can take up operating room time, have to be performed by regional 
anesthesiologist and can add to the cost of the procedure. Evaluating the efficacy of 
these blocks in laparoscopy could change clinical practice in our institution. 
Objectives 
This study aims to compare quality of recovery as well as peri-operative systemic 
opiates use and pain scores in patients undergoing laparoscopic or robotic 
hysterectomy when local anesthetic versus Quadratus Lumborum nerve block (QL-2) is 
added to the standard pain management. 


IRB NUMBER: HSC-MS-22-0158 
IRB APPROVAL DATE: 07/18/2022 
Page 4 of 19 
 
Primary Outcome measure: 
For the primary outcome, we plan to Compare the Quality of Recovery (QOR-40) 
validated questionnaire scores between different arms 
a. At 24 hours 
The Quality of Recovery-40 (QoR-40) questionnaire measures the quality of 
recovery from anesthesia through five dimensions: physical comfort, physical 
independence, emotional state, psychological support, and pain. The validity, 
reliability, ease of use, responsiveness, and cross-cultural adaptation of QoR-40 
have been previously confirmed and this questionnaire has been used 
successfully in several clinical trials. (27). (Appendix 1). This questionnaire takes 
6.3 min to complete and will be filled by the research assistant. 
 
Secondary Outcome measures: 
 
1. Compare pain score (rest and dynamic as coughing or moving from lying down to 
sitting up) between the interventions at several time points: Patients will be 
instructed to use the visual analog scale (NRS), 0 corresponding to no pain at all 
and 10 corresponding to worst imaginable pain) at different time points, 
a. PACU immediately postoperatively 
b. At the time of first opiate administration, 
c. At the time of discharge (most patients are discharged the same day) 
d. On day 1 (24+/=4 hours), 
e. On day 14 
f. At 6 weeks 
2. To collect these pain scores, the EHR will be used to extract the VAS scores 
documented by the RN while the patient is in the PACU and until the patient is 
discharged from the hospital. 
3. A telephone call will be done at 24 hours (+/-4 hours) by the research assistant 
blinded to the procedure and the patient will be seen by the physician in the 
office at the 2 and 6 weeks mark as per usual care. 
4. Compare time to administration of first pain medication in the hospital. 
5. Estimate PONV scores (Worst score) before discharge across different 
interventions. Scale: (none, mild, moderate severe). 
6. Compare the time needed to administer the intervention QL Block. 
7. Compare opiate use in the postoperative period measured in oral morphine 
equivalent (OME) 
a. In the first 24 hours after the surgery (which is the duration of the block). 
b. 2 weeks post-surgery. 
c. 6 weeks post-surgery 
8. We will use the oral morphine conversion table to convert any opiate use to OME 
for each patient (26). 
9. Assess possible complications with each intervention (expected to be low). 


IRB NUMBER: HSC-MS-22-0158 
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Page 5 of 19 
 
 
 
 
Study Population 
− All female patients undergoing laparoscopic or robotic hysterectomy at MHH and will 
be recruited and consented for enrollment by the research team in the preoperative 
area. 
Inclusion Criteria: 
• 
English or Spanish speaking 
• 
American Society of Anesthesiologists (ASA) physical status 1-3, 
• 
Age greater than or equal to 18 years 
• 
Planned laparoscopic or robotic hysterectomy 
 
Exclusion Criteria: 
• 
History of chronic pain requiring preoperative opioids, Known alcoholism disorder 
• 
Congenital coagulopathy, 
• 
Localized soft tissue infection, 
• 
Use of anticoagulants, 
• 
Dementia, inability or refusal to provide consent for the surgery 
• 
Morbid obesity (BMI > 50), due to expected technical difficulty to achieve the block. 
− Usual pain management will continue regardless of which arm of the study patients 
are in and measurements of pain scores, narcotic usage and abdominal numbness 
will be assessed in the post-operative period. 
 
 
Study Design and Procedures 
 
The study will be reported according to the CONSORT (Consolidated Standards of 
Reporting Trials) guidelines (28). 
 
All medications and procedures used in this study (0.25% bupivacaine, dexamethasone, 
acetaminophen, ibuprofen, QL blocks) are FDA approved and have been determined to 
be usual care in the coverage analysis. 
1- Recruitment and consents: 
Patients undergoing laparoscopic or robotic hysterectomy at MHH will be recruited and 
consented for enrollment and block randomized to one of 2 arms: Local anesthesia and 
QL block. The regional anesthesia nurse would consent the patients. 
Spanish consents are available for Spanish speaking patients. 
Patients will not be told if they will be receiving the drug or the control. 


IRB NUMBER: HSC-MS-22-0158 
IRB APPROVAL DATE: 07/18/2022 
Page 6 of 19 
 
Blinding is done by the nurse anesthetist preparing the medication, to assure 
anesthesiologist and research personnel are blinded to the drug used since each 
patient will receive the two modalities, with only one containing the active drug. 
 
Three regional anesthesia nurses will be trained to obtain consents. They are the usual 
medical personel that currently mix and prepare the medication and they have been 
doing so for years. They will be drawing the active or the placebo drug in a sterile 
manner and give the syringes to the “regional” anesthesiologist and the scrub nurse, 
assuring safety of administration. We have discussed this procedure with DeAnn 
Kelly-Williams the Nurse in charge for the Gyn Surgical Services and she is argeable 
with the procedures (Email: Deanna.kelly-williams@memorialhermann,org) 
The procedure is done after the patient is placed under general anesthesia assuring 
blinding for the patient as well as the research assistant who has no access to 
Care4. Regional anesthesiologist and surgeon are also blinded as they will be 
handed the medication sterile in a syringe in both cases. 
 
 
2- Randomization: 
It is done in preoperative unit at the time of obtaining consent via redcap set up by the 
statistician. 
The Nurse anesthetist will then prepare the 20 mls syringes and label them (all drugs 
are visually identical to normal saline) according to the allocation specified by the 
randomization. See figure 3: 
 
Figure 3: 


IRB NUMBER: HSC-MS-22-0158 
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Page 7 of 19 
 
Randomization at 
MHTMC preOp 
area 
 
 
 
 
 
 
 
 
Nurse 
anesthesist 
consents 
patients 
prepares 
syringes, for 
Local, and for 
Block 
 
 
Laparoscopic 
surgery 
 
 
 
 
 
Robotic surgery 
Local 
anesthesia, 
sham QL 
 
Sham local, QL 
 
Local 
anesthesia, 
sham QL 
 
Sham local, QL 
 
 
 
 
 
 
 
 
3- Intervention: 
− The intervention: is performed by the gynecologist for the local anesthetic, and by 
the regional anesthesia team for the blocks (only attendings, fellows (under 
supervision) will be performing the block) under ultrasound guidance. 
− As per current procedures, the nurse anesthetist will fill the syringes and give them 
to the regional anesthesiologist for the QL block and the scrub nurse for the local 
anesthetic. 
− For the placebo QL block, the nurse will draw saline and for the study drug she will 
draw 19 mls of 0.25% bupivacaine and 4 mg of Decadron. Bupivacine and Decadron 
are mixed per the same procedure that is currently done, assuring patient safety. 
− For the Local anesthetic and to blind the surgeon, the nurse anesthesist will draw 
the saline 20 mls for the placebo and the 20 mls of 0.25% bupivacaine for the actual 
local and give it to the scrub nurse via syringe into a sterile cup . 
 
Arm N1- local drug, Sham QL 
Arm N2- Sham local, QL drug 


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IRB APPROVAL DATE: 07/18/2022 
Page 8 of 19 
 
Study 
drug 
Formulation in each syringe 
Arm 
N1 
Local 
0.25% Bupivacine X 20 mls 
Sham 
QL 
20 mls of normal saline 
Arm 
N2 
Sham 
Local 
normal saline 20 mls 
QL 
19 mls of the 0.25% bupivacaine + 1 mls (4 mg of 
Decadron), totaling 20 mls. 
 
Doses of bupivacaine are calculated to stay below the 3mg/kg total dose, and diluted to 
provide the volume effect of the block (as per usual care). 
 
Block procedures: 
The nerve blocks will be placed after the patients are placed under general anesthesia, 
as is usual. 
 
Skin is prepared twice with application of chlorhexidine 0.5% in ethanol 82%. The block 
procedure is performed under ultrasound guidance with a curvilinear transducer 
covered by a sterile transparent plastic sheath. 
 
 The QL block will be administered on both the right and left sides. The transducer is 
placed transverse immediately cranial to the iliac crest and at the level of the 
posterior axillary line. The needle is then inserted inplane from the lateral edge of the 
transducer and advanced through the quadratus lumborum (QL) muscle until the 
needle tip penetrated the epimysium of the anterior part of the QL muscle. The 
anesthetic is injected after repeated negative aspiration tests for blood in the fascial 
interspace between the QL and psoas major (PM) muscles posterior to the 
transversalis fascia (30-32). 
 
Successful injectate spread is confirmed by turning the transducer 90 degrees into the 
longitudinal sagittal plane to see separation of the muscle planes in each type of block. 
 
Subjects are monitored with three-lead electrocardiogaphy, pulse oximetry, and 
noninvasive BP and have two IV lines. 
 
The dermatomal segments of the QL block will be assessed using ice by staff after 1 h 
in the recovery area, and the rest of the study duration does not involve dermatomal 
assessment. 
 
The standard ERAS protocol will followed in all patients: 


 
 
 
 
NON-Diabetics 
Carbohydrate load 
Gatorade 8 oz 2 
hours before 
procedure 
 
Clear liquids up to 
2 hours prior to 
surgery 
 
Tylenol 1gm PO 
 
Celecoxib 200mg 
PO 
 
Gabapentin 300- 
600mg PO 
 
Robaxin 750mg 
PO 
 
Scopolamine 
unless 
contraindicated 
(Avoid in males 
with prostate 
issues) 
 
Reglan-AVOID 
with bowel 
obstructions 
Intra-Op 
Standard 
Induction 
• Reduction/eliminati 
on of narcotics 
beyond induction. 
 
Decadron 4mg (in non 
diabetics) 
 
Infusions 
• Propofol (50-150 
mcg/kg/min) 
• +/- 
Dexmedetomidine 
(200mg/50ccNS) 
0.25-0.5mg/kg IV 
bolus post- 
induction, then 
infusion at 0.1- 
0.3mg/kg/hr 
*Consideration: 
Start at 
0.4mcg/kg/hr then 
decrease after 1 
hour to 
0.2mcg/kg/hr. 
During closing, 
decrease to 0 .1 
mcg/kg/hr 
• Ketamine 10mg/hr 
or 0.25mg/kg/hr. If 
not given per 
infusion, bolus 
patient with 50mg 
prior to incision and 
1 hour prior to close. 
Consider 
0.125mg/kg 
injections q30mins 
IVP if unable to start 
an infusion. 
• +/- Inhalation 
agents (<0.5 MAC 
if used) 
• Acetazolamide (TBD) 
• Max Fentanyl 150 mcg 
(consider baseline HR and 
BP) 
Intra-Op 
 
Last hour of case 
• Terminate 
Ketamine 
infusion 
• Zofran 4mg 
Closing (fascial) 
• Propofol to 
1mcg/kg/hr 
(bolus as needed) 
• Dexmedetomidi 
ne Decrease to 
0.1 mcg/kg/hr 
• Pressure Support 
ventilation 
• 60 % FiO2 
Pointer 
s 
Goal directed fluid 
administration ~3- 
5cc/kg/hr of 
isotonic fluids 
(Avoid Normal 
Saline) 
Minimal Use of 
invasive lines, 
NGTs, drains, 
foleys, and tubes 
Glycemic control 
Blood sugar less 
than 200 (Glucose 
checks q hour) 
Maintenance of 
core temperature 
>36 Optimal 37 
Prevention/Contro 
l of nausea and 
vomiting 
Lung protective 
ventilation. 
Decreased TVs; 
Increased PEEP (6- 
8ml/kg IBW PEEP 
6-10) 
 
 
- Acetaminophen 
650mg by mouth 
every 4 hours- 
- Celecoxib 200mg 
by mouth every 12 
hours 
- Gabapentin 
300mg by mouth 
every 8 hour 
 
- Tramadol 50- 
100mg by mouth 
every 6 hours as 
needed for 
breakthrough pain 
(pending phone 
call) 
 
- If tramadol is 
ineffective at 
controlling 
breakthrough 
pain, the pain 
medication will be 
escalated to 
scheduled 
tramadol 100mg 
every 6 hours with 
oxycodone 5- 
10mg every 4 
hours as needed 
for breakthrough 
pain dependent 
upon pain score. 
Can consider 
Nucynta 
Ondansetron 4mg 
IV every 6 hours 
scheduled 
Promethazine 
12.5mg IM every 6 
hours as needed 
for nausea and/or 
vomiting 
etc. 
 
 
 
 
 
Page 9 of 19 
IRB NUMBER: HSC-MS-22-0158 
IRB APPROVAL DATE: 07/18/2022 
Post-Op 
Pre-Op 


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Page 10 of 19 
 
All patients will receive the same post-operative pain medication regimen (this regimen 
is obtained via consensus from anesthesiologists and surgeons performing 
minimally invasive hysterectomy). 
We will give the patients a Gabapentin, Tramadol prescription (50 mg X15 tablets as the 
only opiate) in addition to the Ibuprofen and Tylenol (See the ERAS protocol for 
details). 
• Tylenol total 30 tab 
• Ibuprofen 600 mg q6hr total 30 tab 
• Gabapentin300 mg total 20 tab 
Tramadol 50 mg total 15 tab 
 
 
5- Comparison: 
The following variables will be recorded to compare the different interventions in the 
following timeline: 
− In PACU: (Registered nurse, performs usual care) data is collected retrospectively 
by research staff 
o Collect pain score rest and dynamic using the Visual analog scale (VAS) 
 Immediately upon arrival 
 At the time of first opiate use 
 Worst pain score 
 At time of discharge 
o Postoperative nausea and vomiting (PONV) score (worst and at the time of 
discharge) 
o Time elapsed to first opiate use (in minutes) 
o Cumulative opiate use in OME in PACU 
o patient satisfaction will be measured on a Likert scale (5 points) 
o The incidence of postoperative adverse events such as nausea, vomiting, 
dizziness, headache, urinary retention, local anesthesia-induced side effects 
(paresthesia, hearing disturbance, visual disturbance, and dysarthria) 
− At 24 hours (+/- 4 hours) telephone call by research assistant blinded to procedure 
o Filled Tramadol (Yes/no) 
o Cumulative opiate use in OME if any (How many Tramadol pills used). 
o QOR-40 (6.3 min validated questionnaire) 
o Dynamic pain score on VAS 
o Patient satisfaction will be measured on a Likert scale (5 points) 
− Day 14: (clinic visit, usual care) 
o Filled Tramadol (Yes/no) 
o Cumulative opiate use in OME if any. (Via number of Tramadol pills left) 
o Dynamic pain score on VAS 
o Clinic visit on day 14 (per usual care) 
o Cumulative opiate use in OME if any (Check number of pills of Tramadol left. 
Versus need for refills). 
o Dynamic pain score on (VAS). 
− 6 weeks clinic visit (per usual care) 
o Complications 


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o Cumulative OME use if any 
o Refill on pain meds, yes/no and which medications. 
During the telephone encounters or the clinical visits, patients will be asked if they filled 
their prescription for Tramadol/narcotic and how many pills they have left). If the patient 
is not seen at the 2 weeks mark for any reason, a telephone call will be done to collect 
that information by the surgeon. 
6- Expected duration of study and subject participation. 
We currently perform at the minimum 5 hysterectomies per week and Memorial 
Hermann Hospital (Laparoscopic and Robotic) and expect to randomize half of the 
patients, to complete the study within up to 2 years after IRB approval. 
 
Sample Size and Power 
 
• 
Based on previous studies, the mean standard deviation of QOR-40 after 
gynecologic laparoscopy are 150-170 and 10-15, respectively. 
• 
A clinically significant difference would be 10-15. 
• 
A sample size of 31 patients per group is needed to detect the difference of 20 
points in the global QOR-40 score, a SD 25, with a Type 1 error of 5% and a 
power of 90%. 
• 
76 patients will be included to allow for a dropout rate of approximately 18%. Lost 
to follow up is expected to be low. 
 
For pain scores in the VAS: Meaningful clinical difference in VAS scores is 30% 
− 
Analysis Plan/Statistics 
 
• 
For baseline patient characteristics, continuous variables will be reported as 
medians with 25th and 75th percentiles (interquartile range [IQR]), and 
categorical variables as counts and percentages. 
• 
To compare across groups, Kruskal-Wallis tests will be performed for continuous 
variables and Chi-square tests for categorical variables. 
 
• 
CONSORT diagram will be performed 
• 
Intention to treat analysis will be performed 
• 
All unadjusted outcomes will be reported descriptively (mean SD/ median IQR) 
• 
For all outcomes, we will conduct intent-to-treat Bayesian analysis to calculate 
probabilities of intervention benefits and harms. We will use neutral priors and exclude 
large treatment effects. We will report posterior medians of group differences, their 
corresponding 95% credible intervals, and probability of treatment benefit. 
 
Primary outcome as QOR will be analyzed with a negative binomial regression model to 
account for expected skewness. The model will include group (local, QL), and type of 
surgery as covariates. We will account for surgery type (Robotic versus laparoscopic 
hysterectomy) simply because of the difference in port placement and port size between 
both approaches. 


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− We will report risk ratios and 95% confidence intervals comparing local to QL block. 
We will assess the normality of the data and robustness of the conclusion using the 
appropriate tests. 
− As the pain scores are repeated over time, a linear mixed model analysis (patient as 
random intercept, patient-time as random slope, unstructured covariance) will be 
undertaken to identify any treatment differences across time. 
− Arrival to PACU is defined as time 0. 
All opioid or pain medications are registered in the subject’s electronic file and are 
tallied to form the total postoperative opioid consumption. 
 
FUNDINGS: 
 
There is no funding for the study, this is PI initiated. 
The cost will be that of the catheters for the blocks which will be donated to the 
anesthesiologist and no charges are incured to the patient or the hospital. 
The anesthesia research team will waive billing for the QL procedure for the study 
patients. Local anesthesia is bundled with the surgery and does not constitute a 
separate charge. Local anesthesia is bundled with the surgery and does not constitute a 
separate charge. The placebo is just 20 mls of saline solution. 
 
OVERSIGHT RESPONSIBILITIES 
 
Oversight of the trial is provided by the Principal Investigator (PI), Dr. Randa Jalloul and 
Co-investigators Drs Nadia Hernandez and Sara Guzman who will be actively involved 
in the conduct of the study. 
MONITORING PROCEDURES 
 
Dr. Jalloul assures that informed consent is obtained prior to performing any research 
procedures, that all subjects meet eligibility criteria, and that the study is conducted 
according to the IRB-approved research plan. 
Study data are accessible at all times for the PI and co-investigators to review. Dr 
Jalloul and Dr Hernandez will review study conduct: accrual, drop-outs, protocol 
deviations on a quarterly basis. The PI, CO-PIs will review AEs individually real-time 
and in aggregate on a quarterly basis. They will also review serious adverse events 
(SAEs), including anesthetic allergy, local anesthetic toxicity, as well risk of infection in 
real-time. The PI ensures all protocol deviations, AEs, and SAEs are reported to the 
IRB according to the applicable regulatory requirements. 
COLLECTION AND REPORTING OF SAEs AND AEs 
 
For this study, the following standard AE definitions are used: 
 
Adverse event: Any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom or disease temporally associated with the use of a 


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Page 13 of 19 
 
medical treatment or procedure, regardless of whether it is considered related to the 
medical treatment or procedure. 
Serious Adverse Event: Any AE that results in any of the following outcomes: 
 
• 
Death 
• 
Life-threatening 
• 
Event requiring inpatient hospitalization or prolongation of existing 
hospitalization 
• 
Persistent or significant disability/incapacity 
AEs are graded according to the following scale: 
Mild: An experience that is transient, & requires no special treatment or 
intervention. The experience does not generally interfere with usual daily 
activities. This includes transient laboratory test alterations. 
Moderate: An experience that is alleviated with simple therapeutic treatments. 
The experience impacts usual daily activities. Includes laboratory test alterations 
indicating injury, but without long-term risk. 
Severe: An experience that requires therapeutic intervention. The experience 
interrupts usual daily activities. If hospitalization (or prolongation of 
hospitalization) is required for treatment it becomes an SAE. 
The study uses the following AE attribution scale 
 
Not related: The AE is clearly not related to the study procedures (i.e., another 
cause of the event is most plausible and/or a clinically plausible temporal 
sequence is inconsistent with the onset of the event). 
Possibly related: An event that follows a reasonable temporal sequence from 
the initiation of study procedures, but that could readily have been produced by a 
number of other factors. 
Related:  The AE is clearly related to the study procedures. 
 
AEs are identified: during hospital admission when potential AEs are assessed through 
a review of the hospital chart on a daily basis and a physical examination of the subject. 
After discharge, AEs are assessed at time of study follow-up visits. 
SAEs and specific procedure-associated AEs are reported to Dr Jalloul and Dr 
Hernandez within 24 hours. In addition, all AEs are reported according to the UT IRB, 
AE reporting guidelines. 


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PLAN FOR DATA MANAGEMENT 
 
Compliance of regulatory documents and study data accuracy and completeness will be 
maintained through an internal study team quality assurance process. 
Confidentiality throughout the trial is maintained by the use of Redcap. 
 
 
Assessment of safety: Safety of the procedure will be ensured by following ASA 
guidelines for regional anesthesia, as well as using ultrasound for placement of the 
nerve blockade as is standard of care. We will also ensure that post-operative 
medications are not prescribed to patients who may have an allergy to one of the 
medications, as well as adjusting the doses prescribed to patients who may have renal 
or hepatic dysfunction. The study will not incur more than minimal risk for the 
intervention and the placebo group. 
 
 
Ethics 
− IRB approval will be sought for this study. 
− Patients will undergo standard consent for regional anesthesia and for participation 
in this study. 
− The study was conducted in accordance with the Consolidated Standards of 
Reporting Trials (CONSORT) statement, the Helsinki Declaration, and monitored by 
the Good Clinical Practice Unit 
− Will register the trial once the IRB is approved. 
 
Data handling and record keeping 
− Narcotic consumption, pain score patient data will be maintained in a secure file by 
the PI using Redcap to protect patient data. 
− All nurses pre-operatively and post-operatively will be educated regarding the study 
and appropriate documentation of pain scores and medication requirements. 
 
Publication Plan 
− Plan to publish in the JMIG 
− Results are not returned to subjects 


IRB NUMBER: HSC-MS-22-0158 
IRB APPROVAL DATE: 07/18/2022 
Page 15 of 19 
 
Characteristic 
N1 
N2 
Age 
Race 
Height 
Abdominal circumference 
Weight 
BMI 
Smoking 
Diabetes status 
Parity 
Hospital system 
Planned procedure 
Actual procedure 
Number of trocars used 
Largest trocar size (if single site used size of 
fascia incision) 
Largest trocar location 
Uterine size in grams 
Duration of surgery from cut to close 
Total anesthesia time 
Intraoperative complications 
Length of Hospital stay 
 
 
Incidence of adverse 
events 
N1 
N2 
Nausea 
Vomiting 
Dizziness 
Headache 
Urinary retention 
Needle-insertion-site 
pain 
Hematoma 
 
 
Outcomes 
N1 
N2 
Opiate use: yes/no 
Total number of Tramadol pills used, or other 
medications if any 
QOR-40 (6.3 min validated questionnaire) 
At 24 hours (+/- 4 hours): tel call by research nurse 
Cumulative Opiate use in (OME) 


IRB NUMBER: HSC-MS-22-0158 
IRB APPROVAL DATE: 07/18/2022 
Page 16 of 19 
 
OME in PACU 
OME At 24 hours (20-28 hours): tel call by research 
nurse 
OME at Day 14, Clinic visit 
OME at 6 weeks clinic visit (per usual care) 
Pain scores at rest 
PACU arrival 
PACU At the time of first opiate use 
PACU Worst pain score 
PACU At time of discharge 
At 36 hours (28-44 hours): tel call by research nurse 
Day 14, Clinic visit 
6 weeks clinic visit (per usual care) 
Dynamic pain score 
PACU arrival 
PACU At the time of first opiate use 
PACU Worst pain score 
PACU At time of discharge 
At 36 hours (28-44 hours): tel call by research nurse 
Day 14, Clinic visit 
6 weeks clinic visit (per usual care) 
Time elapsed to first opiate use (in min) 
 
Duration of surgery, intraop opiates use and complications within 6 weeks, capturing 
unscheduled visits, ER visits etc.. 
 
 
 
References: 
 
 
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Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA 
Surg. 2017;152(6):e170504. 


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