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CompletedNCT03801265Updated Jul 15, 2021Results posted

Lumbar Plexus vs Quadratus Lumborum Block in Post-operative Pain Following Total Hip Replacement

A Phase 4 interventional study of Lumbar plexus block and Quadratus lumborum type 3 block in Hip Osteoarthritis, sponsored by Sharad Khetarpal. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-07-15.

Sponsored by Sharad Khetarpal · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hip Osteoarthritis

Keywords

  • lumbar plexus block
  • quadratus lumborum block
  • total hip arthroplasty
03

In context

Osteoarthritis, Hip

628 studies on the registry are indexed under Osteoarthritis, Hip; 121 are open to participants now.

This study's enrollment of 46 is below the median of 90 across 450 interventional studies indexed under Osteoarthritis, Hip.

Browse Osteoarthritis, Hip studies →

Lead sponsor

This is the only study on the registry with Sharad Khetarpal as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Active comparator
    Lumbar Plexus block

    0.5% ropivacaine 100 mg (20 ml) will be injected

    Procedure: Lumbar plexus block · Drug: Ropivacaine injection

  • Experimental
    Quadratus Lumborum type 3 block

    0.5% ropivacaine 100 mg (20 ml) will be injected

    Procedure: Quadratus lumborum type 3 block · Drug: Ropivacaine injection

Interventions

  • ProcedureLumbar plexus block

    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.

  • ProcedureQuadratus lumborum type 3 block

    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.

  • DrugRopivacaine injection

    0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.

06

What researchers measure

Primary outcomes

  1. Pain at Rest After Surgery

    Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.

    Time frame: 6 hours after surgery

  2. Pain With Movement After Surgery

    Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

    Time frame: 6 hours after surgery

  3. Pain at Rest After Surgery

    Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.

    Time frame: 12 hours after surgery

  4. Pain With Movement After Surgery

    Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

    Time frame: 12 hours after surgery

  5. Pain at Rest After Surgery

    Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.

    Time frame: 24 hours after surgery

  6. Pain With Movement After Surgery

    Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Pain During Physical Therapy

    Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

    Time frame: 24 hours after surgery

  2. Total Opioid Consumption During 24 Hours After Surgery

    Narcotics will be converted to oral morphine equivalents

    Time frame: 24 hours after surgery

  3. Postoperative Time to Accomplish Walking 100 Feet

    This measurement is from T0 being out of surgery room time to the point at which the participant was able to walk 100 feet during the first day post-surgery. Values were abstracted from the patient medical records.

    Time frame: within 24 hours after surgery

  4. Block Procedure Duration

    Duration that the patient underwent the block procedure during surgery in minutes

    Time frame: during surgery

  5. Patients With Postoperative Quadriceps Weakness

    patients who report having post-surgical quadriceps weakness.

    Time frame: 12 hours after surgery

  6. Total Acetaminophen Consumption During 24 Hours After Surgery

    Patient electronic medical records were reviewed for total acetaminophen consumption during 24 hours after surgery in milligrams (mg)

    Time frame: 24 hours after surgery

  7. Total Celecoxib Consumption During 24 Hours After Surgery

    Patient electronic medical records were reviewed for total celecoxib consumption during 24 hours after surgery in milligrams (mg)

    Time frame: 24 hours after surgery

  8. Total Ketorolac Consumption During 24 Hours After Surgery

    Patient electronic medical records were reviewed for total ketorolac consumption during 24 hours after surgery in milligrams (mg)

    Time frame: 24 hours after surgery

  9. Total Gabapentin Consumption During 24 Hours After Surgery

    Patient electronic medical records were reviewed for total gabapentin consumption during 24 hours after surgery in milligrams (mg)

    Time frame: 24 hours after surgery

  10. Total Oral Ketamine Consumption During 24 Hours After Surgery

    Patient electronic medical records were reviewed for total oral ketamine consumption during 24 hours after surgery in milligrams (mg)

    Time frame: 24 hours after surgery

  11. Opioid Consumption During 0-6 Hours After Surgery

    Narcotics will be converted to oral morphine equivalents

    Time frame: 6 hours after surgery

  12. Opioid Consumption During 6-12 Hours After Surgery

    Narcotics will be converted to oral morphine equivalents

    Time frame: 6-12 hours after surgery

  13. Opioid Consumption During 12-24 Hours After Surgery

    Narcotics will be converted to oral morphine equivalents

    Time frame: 12-24 hours after surgery

07

Results

Posted Jul 15, 2021
Limitations and caveats
The study was conducted at a single-center, potentially confounding external validity. Though the desired statistical power was achieved, our sample was still small. More non-inferiority studies are needed to confirm our results.

Participant flow

Participant flow — Overall Study
MilestoneLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Started2323
Completed2323
Not completed00

Outcome measures

PrimaryPain at Rest After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.

Time frame:
6 hours after surgery
Reported as:
Mean · score on a scale
Pain at Rest After Surgery
score on a scaleLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Pain at Rest After Surgery3.4 ± 3.03.6 ± 1.9
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .770
PrimaryPain With Movement After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Time frame:
6 hours after surgery
Reported as:
Mean · score on a scale
Pain With Movement After Surgery
score on a scaleLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Pain With Movement After Surgery4.9 ± 3.24.7 ± 2.0
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .826
PrimaryPain at Rest After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.

Time frame:
12 hours after surgery
Reported as:
Mean · score on a scale
Pain at Rest After Surgery
score on a scaleLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Pain at Rest After Surgery3.0 ± 2.92.8 ± 2.0
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .859
PrimaryPain With Movement After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Time frame:
12 hours after surgery
Reported as:
Mean · score on a scale
Pain With Movement After Surgery
score on a scaleLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Pain With Movement After Surgery4.5 ± 2.84.6 ± 2.1
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .904
PrimaryPain at Rest After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain at rest. A higher score means worse outcomes.

Time frame:
24 hours after surgery
Reported as:
Median · score on a scale
Pain at Rest After Surgery
score on a scaleLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Pain at Rest After Surgery2.8 ± 2.61.8 ± 1.5
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .122
PrimaryPain With Movement After Surgery

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Time frame:
24 hours after surgery
Reported as:
Median · score on a scale
Pain With Movement After Surgery
score on a scaleLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Pain With Movement After Surgery4.9 ± 2.84.3 ± 1.8
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .379
SecondaryPain During Physical Therapy

Visual Analog Scale (VAS) score (0-10, 0 means no pain, 10 means the worst pain) of pain with movement. A higher score means worse outcomes.

Time frame:
24 hours after surgery
Reported as:
Mean · score on a scale
Pain During Physical Therapy
score on a scaleLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Pain During Physical Therapy4.3 ± 2.54.2 ± 1.3
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .881
SecondaryTotal Opioid Consumption During 24 Hours After Surgery

Narcotics will be converted to oral morphine equivalents

Time frame:
24 hours after surgery
Reported as:
Mean · mg oral morphine equivalents
Total Opioid Consumption During 24 Hours After Surgery
mg oral morphine equivalentsLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Total Opioid Consumption During 24 Hours After Surgery14.0 ± 9.314.7 ± 10.7
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .818
SecondaryPostoperative Time to Accomplish Walking 100 Feet

This measurement is from T0 being out of surgery room time to the point at which the participant was able to walk 100 feet during the first day post-surgery. Values were abstracted from the patient medical records.

Time frame:
within 24 hours after surgery
Reported as:
Mean · minutes
Postoperative Time to Accomplish Walking 100 Feet
minutesLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Postoperative Time to Accomplish Walking 100 Feet1449.1 ± 760.71358.3 ± 715.5
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .678
SecondaryBlock Procedure Duration

Duration that the patient underwent the block procedure during surgery in minutes

Time frame:
during surgery
Reported as:
Mean · minutes
Block Procedure Duration
minutesLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Block Procedure Duration11.7 ± 6.16.6 ± 4.7
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .002
SecondaryPatients With Postoperative Quadriceps Weakness

patients who report having post-surgical quadriceps weakness.

Time frame:
12 hours after surgery
Reported as:
Count of participants · Participants
Patients With Postoperative Quadriceps Weakness
ParticipantsLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Patients With Postoperative Quadriceps Weakness156
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Chi-squared · p = .007
SecondaryTotal Acetaminophen Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total acetaminophen consumption during 24 hours after surgery in milligrams (mg)

Time frame:
24 hours after surgery
Reported as:
Mean · milligrams (mg)
Total Acetaminophen Consumption During 24 Hours After Surgery
milligrams (mg)Lumbar Plexus BlockQuadratus Lumborum Type 3 Block
Total Acetaminophen Consumption During 24 Hours After Surgery2782.6 ± 902.33087.0 ± 949.3
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .271
SecondaryTotal Celecoxib Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total celecoxib consumption during 24 hours after surgery in milligrams (mg)

Time frame:
24 hours after surgery
Reported as:
Mean · milligrams (mg)
Total Celecoxib Consumption During 24 Hours After Surgery
milligrams (mg)Lumbar Plexus BlockQuadratus Lumborum Type 3 Block
Total Celecoxib Consumption During 24 Hours After Surgery191.3 ± 185.7178.3 ± 180.8
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .810
SecondaryTotal Ketorolac Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total ketorolac consumption during 24 hours after surgery in milligrams (mg)

Time frame:
24 hours after surgery
Reported as:
Mean · milligrams (mg)
Total Ketorolac Consumption During 24 Hours After Surgery
milligrams (mg)Lumbar Plexus BlockQuadratus Lumborum Type 3 Block
Total Ketorolac Consumption During 24 Hours After Surgery9.8 ± 17.312.4 ± 24.2
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .676
SecondaryTotal Gabapentin Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total gabapentin consumption during 24 hours after surgery in milligrams (mg)

Time frame:
24 hours after surgery
Reported as:
Mean · milligrams (mg)
Total Gabapentin Consumption During 24 Hours After Surgery
milligrams (mg)Lumbar Plexus BlockQuadratus Lumborum Type 3 Block
Total Gabapentin Consumption During 24 Hours After Surgery382.6 ± 238.7395.7 ± 481.9
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .908
SecondaryTotal Oral Ketamine Consumption During 24 Hours After Surgery

Patient electronic medical records were reviewed for total oral ketamine consumption during 24 hours after surgery in milligrams (mg)

Time frame:
24 hours after surgery
Reported as:
Mean · milligrams (mg)
Total Oral Ketamine Consumption During 24 Hours After Surgery
milligrams (mg)Lumbar Plexus BlockQuadratus Lumborum Type 3 Block
Total Oral Ketamine Consumption During 24 Hours After Surgery7.4 ± 12.513.5 ± 22.9
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .270
SecondaryOpioid Consumption During 0-6 Hours After Surgery

Narcotics will be converted to oral morphine equivalents

Time frame:
6 hours after surgery
Reported as:
Mean · mg oral morphine equivalents
Opioid Consumption During 0-6 Hours After Surgery
mg oral morphine equivalentsLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Opioid Consumption During 0-6 Hours After Surgery3.4 ± 3.26.3 ± 4.5
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .015
SecondaryOpioid Consumption During 6-12 Hours After Surgery

Narcotics will be converted to oral morphine equivalents

Time frame:
6-12 hours after surgery
Reported as:
Mean · mg oral morphine equivalents
Opioid Consumption During 6-12 Hours After Surgery
mg oral morphine equivalentsLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Opioid Consumption During 6-12 Hours After Surgery5.0 ± 4.23.4 ± 4.0
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .203
SecondaryOpioid Consumption During 12-24 Hours After Surgery

Narcotics will be converted to oral morphine equivalents

Time frame:
12-24 hours after surgery
Reported as:
Mean · mg oral morphine equivalents
Opioid Consumption During 12-24 Hours After Surgery
mg oral morphine equivalentsLumbar Plexus BlockQuadratus Lumborum Type 3 Block
Opioid Consumption During 12-24 Hours After Surgery5.7 ± 4.65.0 ± 5.9
Statistical analysis
  • Lumbar Plexus Block vs Quadratus Lumborum Type 3 Block · Wilcoxon (Mann-Whitney) · p = .672

Adverse events

Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Lumbar Plexus Block0/23 (0%)0/23 (0%)0/23 (0%)
Quadratus Lumborum Type 3 Block0/23 (0%)0/23 (0%)0/23 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Lumbar Plexus BlockQuadratus Lumborum Type 3 BlockTotal
Mean65.7 ± 9.868.6 ± 11.867.1 ± 10.7
Sex: Female, Male
Sex: Female, Male(Participants)Lumbar Plexus BlockQuadratus Lumborum Type 3 BlockTotal
Female111324
Male121022
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Lumbar Plexus BlockQuadratus Lumborum Type 3 BlockTotal
Caucasian161935
African American7411
Region of Enrollment
Region of Enrollment(Participants)Lumbar Plexus BlockQuadratus Lumborum Type 3 BlockTotal
United States232346
08

Study locations

1 site
  • UPMC Presbyterian-Shadyside Hospital
    Pittsburgh, Pennsylvania 15232, United States
09

References and documents

Publications

  • Ilfeld BM, Ball ST, Gearen PF, Le LT, Mariano ER, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Meyer RS. Ambulatory continuous posterior lumbar plexus nerve blocks after hip arthroplasty: a dual-center, randomized, triple-masked, placebo-controlled trial. Anesthesiology. 2008 Sep;109(3):491-501. doi: 10.1097/ALN.0b013e318182a4a3. PubMed 18719448 ↗
  • Weller RS, Gerancher JC, Crews JC, Wade KL. Extensive retroperitoneal hematoma without neurologic deficit in two patients who underwent lumbar plexus block and were later anticoagulated. Anesthesiology. 2003 Feb;98(2):581-5. doi: 10.1097/00000542-200302000-00044. No abstract available. PubMed 12552223 ↗
  • Ilfeld BM, Duke KB, Donohue MC. The association between lower extremity continuous peripheral nerve blocks and patient falls after knee and hip arthroplasty. Anesth Analg. 2010 Dec;111(6):1552-4. doi: 10.1213/ANE.0b013e3181fb9507. Epub 2010 Oct 1. PubMed 20889937 ↗
  • Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363. PubMed 27513972 ↗
  • La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406. PubMed 28036319 ↗
  • Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17. PubMed 30386022 ↗
  • Børglum J, Moriggl B, Jensen K, Lønnqvist P, Christensen AF, Sauter A, Bendtsen TF. Ultrasound-guided transmuscular quadratus lumborum blockade. British Journal of Anaesthesia 111:eLetters Supplement, 2013.
  • Winnie AP, Ramamurthy S, Durrani Z, Radonjic R: Plexus blocks for lower extremity surgery: New answers to old problems. Anesth Review 1974; 1:11
  • Polania Gutierrez JJ, Ben-David B, Rest C, Grajales MT, Khetarpal SK. Quadratus lumborum block type 3 versus lumbar plexus block in hip replacement surgery: a randomized, prospective, non-inferiority study. Reg Anesth Pain Med. 2021 Feb;46(2):111-117. doi: 10.1136/rapm-2020-101915. Epub 2020 Nov 11. PubMed 33177220 ↗

Study documents

  • Study protocol · Jun 5, 2019
  • Statistical analysis plan · Jun 5, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03801265
Lead sponsor
Sharad Khetarpal
Responsible party
Sharad Khetarpal (Clinical Assistant Professor, University of Pittsburgh) — Sponsor-investigator
First posted
Jan 11, 2019
Start date
Mar 19, 2019
Primary completion
May 30, 2020
Completion
May 30, 2020
Results posted
Jul 15, 2021
Last update
Jul 15, 2021

Study contacts

Sharad Khetarpal, MD
principal investigator · Department of Anesthesiology, University of Pittsburgh Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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