Clinical trial NCT03801265
Conditions: Hip Osteoarthritis
Keywords: lumbar plexus block quadratus lumborum block total hip arthroplasty
Sponsor: Sharad Khetarpal
Start date: 2019-03-19; Completion date: 2020-05-30
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Lumbar Plexus (LP) block is currently used as the standard-of-care regional anesthesia technique to provide postoperative pain management after primary hip replacement surgery at UPMC Shadyside Hospital. However, the LP technique is complex and can be associated with potentially serious side effects, including nerve injury, major bleeding, retroperitoneal hematoma, and intrathecal injection of local anesthetic. In rare instances the LP block can also lead to motor blockade, interfering with early ambulation. There are several case reports of Quadratus Lumborum inter-fascial block (QL3) giving equally adequate pain relief after total hip replacement surgery, and this QL3 block is performed routinely at this institution. The benefits to inter-fascial administration of local anesthetic include the avoidance of theoretical nerve injury, bleeding and intrathecal anesthetic administration associated with the direct interaction between the nerve and the nerve block needle. The purpose of this study is to show that QL3 block is non-inferior to the standard-of-care lumbar plexus block and should be used more regularly in hip replacement surgery. The study will be conducted as a prospective, randomized (1:1), double-blind, non-inferiority, active-comparator trial. The investigators plan to enroll 40 subjects, 20 in each treatment group. This study will prospectively investigate the efficacy of QL3 versus Classic LP block for post-operative pain management in subjects undergoing primary, unilateral hip replacement surgery and prospectively compare QL3 versus Classic LP block in time to mobilization and physical therapy response. Primary outcome measures include pain at rest and with movement at 6, 12 and 24 hours after surgery. Secondary outcomes will be time for first request for pain medication, total pain medications (narcotics and non-narcotic analgesics) given in 24 hours and the time of participant's ability to walk 100 feet as recorded by a physical therapist.

Detailed description:
Eligible patients will be approached for the study by the PI or Sub-I in the pre-operative area on their day of surgery. The anesthesiology investigator will speak with the patient about the study behind a closed drape and the patient will have adequate time to consider the consent and ask questions regarding risk factors associated with each type of block. Once consented, the patient will be randomized by computer generated random number to one of the two treatment groups. Once assigned the treatment allocation, only the clinician administering the block will be unblinded to the randomization outcome. If randomized to the LP block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 1 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.If randomized to the QL3 block, an anesthesiologist on the Acute Interventional Perioperative Pain Service (AIPPS) will administer the block with this approach:Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. For both treatment groups, the local anesthetic used will be 100 mg 0.5% ropivacaine. 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 outcome measures. These include pain at rest and with movement at 6, 12 and 24 hours after surgery, time for first request for pain medication, total pain medications (narcotics and non-narcotic analgesics) given in 24 hours and the time of participant's ability to walk 100 feet as recorded by physical therapist. This information will be captured from the patient's electronic medical record.

Minor changes were made to the outcome measures after the original approval of this submission. This was only to clarify the specific measures from the more general descriptions in the original.

Arms: arm 1: 0.5% ropivacaine 100 mg (20 ml) will be injected arm 2: 0.5% ropivacaine 100 mg (20 ml) will be injected
Interventions: intervention 1: Lumbar plexus block intervention 2: Quadratus lumborum type 3 block intervention 3: Ropivacaine injection
Intervention descriptions: intervention 1: Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes. intervention 2: Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited. intervention 3: 0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

Protocol documents:
Prot_000.pdf: 
Quadratus Lumborum block (QL 3) versus Classic  
 
Sharad Khetarpal, MD 
Lumbar Plexus block in Total Primary, Unilateral Hip  
Replacement Surgery: A Prospective, Randomized, Double-Blind,  
Active Comparator Trial 
Page 1 of 7 
 
 
Official Title: A Prospective, Randomized, Double-Blind, Active-Comparator, Non-Inferiority 
study to observe relative efficacy of Ultrasound-Guided Supra-iliac Transmuscular Quadratus 
Lumborum block (QL 3) vs. classic Lumbar Plexus block in managing post-operative pain 
following total hip replacement surgery. 
ClinicalTrials.gov ID (NCT number): NCT03801265 
Document Date: June 5th, 2019 
 
 
 
 
 
 
 
 
 
 
 
 


Quadratus Lumborum block (QL 3) versus Classic  
 
Sharad Khetarpal, MD 
Lumbar Plexus block in Total Primary, Unilateral Hip  
Replacement Surgery: A Prospective, Randomized, Double-Blind,  
Active Comparator Trial 
Page 2 of 7 
 
 
Background 
The Lumbar Plexus (LP) block is a well-established and widely studied regional analgesia procedure 
proven to provide postoperative pain management after primary hip replacement surgery (1).  However, 
the technique of LP block is considered by those with limited experience as complex and associated with 
potentially serious side effects, including nerve injury, major bleeding, retroperitoneal hematoma, and 
intrathecal injection of local anesthetic (2). Also, the LP block, when preformed with a concentrated 
local anesthetic solution, may lead to motor blockade, interfering with early ambulation and delaying 
initiation of physical therapy before transferring the patient to floor from PACU (3).  Despite this, the 
very skilled Acute and Interventional Perioperative Pain Service (AIPPS) has safely administered over 
10,000 LP blocks in this institution, and therefore the LP block is considered the standard of care for hip 
replacement surgery at Shadyside Hospital. The LP block is currently a part of an approved Enhanced 
Recovery After Surgery protocol (ERAS) which uses multimodal analgesia, restricted goal directed fluids 
in intraoperative period, and minimal invasive surgical technique, which are all directed towards getting 
patient ready for successful outcome and early discharge.  
In the past few years, consideration has been given to inter-facial administration of local anesthetic to 
avoid theoretical nerve injury, bleeding and intrathecal anesthetic administration associated with the 
direct interaction between the nerve and the nerve block needle.  Thus, the use of inter-fascial blocks 
represents an attractive alternative to traditional peripheral nerve blocks to provide regional analgesia 
utilizing local anesthetics as part of multimodal analgesic protocol. There are several case reports of 
Quadratus Lumborum inter-fascial block giving adequate pain relief after total hip replacement surgery 
and this QL3 block is preformed routinely in this institution 4-6. Several of early case reports were 
published in many peer review journals from our own institution, although randomized control studies 


Quadratus Lumborum block (QL 3) versus Classic  
 
Sharad Khetarpal, MD 
Lumbar Plexus block in Total Primary, Unilateral Hip  
Replacement Surgery: A Prospective, Randomized, Double-Blind,  
Active Comparator Trial 
Page 3 of 7 
 
are yet to be conducted. The inter-facial block is theoretically easier to preform and presents less risk to 
the patient, as the local anesthetic is deposited further away from the nerve plexus. The purpose of this 
study is to show that inter-facial block is non-inferior to the standard-of-care lumbar plexus block, and 
should be used more regularly in hip replacement surgery.  
Specific Aims 
1. 
This study will prospectively investigate the efficacy of Quadratus Lumborum block (QL 3) versus 
Classic Lumbar Plexus block for post-operative pain management in subjects undergoing primary, 
unilateral hip replacement surgery. Primary outcome measures include pain with movement and total 
narcotic consumption in 24 or until discharge.  
2. 
To prospectively compare Quadratus Lumborum block (QL 3) versus Classic Lumbar Plexus block 
in time to mobilization and physical therapy response 
Hypothesis 
There will be no difference in efficacy between 2 groups.  
Study Design 
The study will be conducted as a prospective, randomized, double-blind, 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. Trial will be 
registered at www.clinicaltrial.gov before beginning recruitment. 
Recruitment 
Potential subjects will be recruited in the pre-operative area of Shadyside hospital on the day of their 
scheduled hip replacement surgery. Patients who agree to participate in the trial will sign an IRB 


Quadratus Lumborum block (QL 3) versus Classic  
 
Sharad Khetarpal, MD 
Lumbar Plexus block in Total Primary, Unilateral Hip  
Replacement Surgery: A Prospective, Randomized, Double-Blind,  
Active Comparator Trial 
Page 4 of 7 
 
approved Informed Consent Form. Forty patients are expected be enrolled in this trial, with twenty in 
each group.  
Randomization Process 
Participating patients will be randomized by computer generated random numbers to either the 
Quadratus Lumborum block (QL 3) or the Classic Lumbar Plexus group, which is the standard of car in 
this institution for hip replacement surgery. 
Inclusion Criteria: 
1. Patients 18-90 years old 
2. Primary unilateral total hip arthroplasty 
3. BMI 20 – 36 
4. Male and Female 
5. All races 
Exclusion Criteria: 
1. 
Patient refusal 
2. 
ASA class< or = 4 
3. 
Pregnancy 
4. 
Any condition precluding patient going home with in 24 hours of surgery 
5. 
Non-English speaking or inability to participate in the study 
6. 
Patients with coagulopathy or on therapeutic anticoagulation 
7. 
Chronic Steroid Use 
8. 
Narcotic Addiction 
Treatment Groups 
Group 1:  20 Subjects randomized to Group 1 will have a classic lumbar plexus block with 20mg 0.5% 
ropivacaine, which is standard of care.  


Quadratus Lumborum block (QL 3) versus Classic  
 
Sharad Khetarpal, MD 
Lumbar Plexus block in Total Primary, Unilateral Hip  
Replacement Surgery: A Prospective, Randomized, Double-Blind,  
Active Comparator Trial 
Page 5 of 7 
 
LP Block Approach: Patient will be positioned in lateral decubitus position with side to be blocked facing 
upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn 
connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. 
The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated 
needle will be used and advanced until it contacted the transverse process. Needle will then be 
redirected cephalad or causdad and advanced 1 cm, until the quadriceps femoris twitch is obtained as 
described by Winnie et al. 8 Local anesthetic will then be injected after confirming a motor response 
between 0.3-0.5 milli amperes. 
Group 2: 20 subjects randomized to Group 2 will have a Quadratus Lumborum block (QL 3) using 20mg 
of 0.5% ropivacaine  
QL3 Approach: Patient will be placed in a lateral position with the side to be blocked facing up. A low 
frequency transducer will be used to identify three layers of abdominal musculature, probe will be then 
moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then 
identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to 
visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified 
lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and 
advanced intramuscularly through the QL to interfacial plane between QL and psoas major as described 
by Børglum, Jens, et al 7 and local anesthetic is deposited. 
Anesthetic Management  
Participants in both treatment groups will receive standard ERAS multi-modal analgesics pre-operatively 
(Celebrex 200 mg PO and Acetaminophen 1000 mg PO) and will receive the standard ERAS anesthetic 
technique intraoperatively (Spinal neuraxial block with hyperbaric bupivacaine in standard doses (1.4 – 


Quadratus Lumborum block (QL 3) versus Classic  
 
Sharad Khetarpal, MD 
Lumbar Plexus block in Total Primary, Unilateral Hip  
Replacement Surgery: A Prospective, Randomized, Double-Blind,  
Active Comparator Trial 
Page 6 of 7 
 
1.6 mg), intraoperative propofol infusion (50-100 mcg/kg/min), intravenous dexmetetomidine (12-20 
mcg) infusion, and intravenous Ketamine (20 mg)). Participants will also follow ERAS protocol for fluid 
management intraoperatively. Post-operative pain management will also follow standard ERAS protocol, 
using IV hydromorphone (0.2 mg) and PO oxycodone ( 5-10 mg) on request by patient for moderate to 
severe pain (VAS >5).  
 
Data Collection and Outcome Measures 
Once the patient has signed the informed consent document they will be randomized to receive with 
the LP block or the QL3 block. Only the person administering the block will be unblinded, both the 
patient and the outcome assessors will be blinded to the treatment group allocation. Primary outcome 
measures include pain with movement at 6 hours after surgery, time for 1st request for pain medication, 
total pain medications (narcotics and non-narcotic analgesics) given in 24 hours or till time to discharge.  
If patient is discharged within 24 hours, the time of participant’s ability to walk 100 feet as recorded by 
physical therapist will be collected.  
References 
1.Ilfeld, Brian M., et al. "Ambulatory Continuous Posterior Lumbar Plexus Nerve Blocks after Hip 
ArthroplastyA Dual-center, Randomized, Triple-masked, Placebo-controlled Trial." Anesthesiology: The 
Journal of the American Society of Anesthesiologists 109.3 (2008): 491-501. 
 
2. Weller, Robert S., et al. "Extensive retroperitoneal hematoma without neurologic deficit in two patients 
who underwent lumbar plexus block and were later anticoagulated." Anesthesiology: The Journal of the 
American Society of Anesthesiologists 98.2 (2003): 581-585.  
 
3. Ilfeld, Brian M., Kimberly B. Duke, and Michael C. Donohue. "The association between lower extremity 
continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty." Anesthesia and 
analgesia 111.6 (2010): 1552. 
 
4. Hockett, Margaret M., Sheena Hembrador, and Alex Lee. "Continuous quadratus lumborum block for 
postoperative pain in total hip arthroplasty: a case report." A&A Practice 7.6 (2016): 129-131.  
 


Quadratus Lumborum block (QL 3) versus Classic  
 
Sharad Khetarpal, MD 
Lumbar Plexus block in Total Primary, Unilateral Hip  
Replacement Surgery: A Prospective, Randomized, Double-Blind,  
Active Comparator Trial 
Page 7 of 7 
 
5. La Colla, Luca, Bruce Ben-David, and Rita Merman. "Quadratus lumborum block as an alternative to 
lumbar plexus block for hip surgery: a report of 2 cases." A&A Practice 8.1 (2017): 4-6.  
 
6. Adhikary, Sanjib D., et al. "Transmuscular quadratus lumborum versus lumbar plexus block for total hip 
arthroplasty: A retrospective propensity score matched cohort study." Journal of anaesthesiology, clinical 
pharmacology 34.3 (2018): 372. 
 
7. Børglum, Jens, et al. "Ultrasound-guided transmuscular quadratus lumborum blockade." BJA: British 
Journal of Anaesthesia 111.eLetters Supplement (2013). 
 
8. Winnie AP, Ramamurthy S, Durrani Z, Radonjic R: Plexus blocks for lower extremity surgery: New 
answers to old problems. Anesth Review 1974; 1:11 
 

SAP_001.pdf: 
Quadratus Lumborum block (QL 3) versus Classic  
 
Sharad Khetarpal, MD 
Lumbar Plexus block in Total Primary, Unilateral Hip  
Replacement Surgery: A Prospective, Randomized, Double-Blind,  
Active Comparator Trial 
Page 1 of 2 
 
 
Official Title: A Prospective, Randomized, Double-Blind, Active-Comparator, Non-Inferiority 
study to observe relative efficacy of Ultrasound-Guided Supra-iliac Transmuscular Quadratus 
Lumborum block (QL 3) vs. classic Lumbar Plexus block in managing post-operative pain 
following total hip replacement surgery. 
ClinicalTrials.gov ID (NCT number): NCT03801265 
Document Date: June 5th, 2019 
 
 
 
 
 
 
 
 
 
 
 
 


Quadratus Lumborum block (QL 3) versus Classic  
 
Sharad Khetarpal, MD 
Lumbar Plexus block in Total Primary, Unilateral Hip  
Replacement Surgery: A Prospective, Randomized, Double-Blind,  
Active Comparator Trial 
Page 2 of 2 
 
 
Statistical Analysis Plan 
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 statistically 
significant. SPSS 12.0 software will be utilized for statistical analysis. Intention to treat analysis will also 
be utilized for this study.  
Sample size and power analysis. Sample sizes of 20 in the LP block group and 20 in the QL3 block group 
achieve ≥ 90% power to detect non-inferiority using a one-sided Mann-Whitney test assuming the actual 
distribution is normal. The margin of non-inferiority is 0.5. The true difference between the means is 
assumed to be -0.2. The significance level (alpha) of the test is 0.05. The data are drawn from 
populations with standard deviations of 0.7 and 0.3 (PASS 15 Power Analysis and Sample Size Software 
(2017). NCSS, LLC. Kaysville, Utah, USA, ncss.com/software/pass).