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

NCT03801265 | Completed Phase 4 Results FDA Drug

• 1 other identifier: PRO18120275
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Osteoarthritis

Keywords

lumbar plexus block; quadratus lumborum block; total hip arthroplasty

Outcome Measures

Primary Outcomes (6)

• 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.

  6 hours after surgery

• 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.

  6 hours after surgery

• 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.

  12 hours after surgery

• 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.

  12 hours after surgery

• 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.

  24 hours after surgery

• 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.

  24 hours after surgery

Secondary Outcomes (13)

• Pain During Physical Therapy

  24 hours after surgery

• Total Opioid Consumption During 24 Hours After Surgery

  24 hours after surgery

• Postoperative Time to Accomplish Walking 100 Feet

  within 24 hours after surgery

• Block Procedure Duration

  during surgery

• Patients With Postoperative Quadriceps Weakness

  12 hours after surgery

Study Arms (2)

Lumbar Plexus block

ACTIVE COMPARATOR

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

Procedure: Lumbar plexus block; Drug: Ropivacaine injection

Quadratus Lumborum type 3 block

EXPERIMENTAL

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

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

Interventions

Lumbar plexus block PROCEDURE

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.

Lumbar Plexus block

Quadratus lumborum type 3 block PROCEDURE

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.

Quadratus Lumborum type 3 block

Ropivacaine injection DRUG

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

Lumbar Plexus block; Quadratus Lumborum type 3 block

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18-90 years old
• Primary unilateral total hip arthroplasty
• BMI 20 - 36
• Male and Female
• All races

You may not qualify if:

• Patient refusal
• ASA class \> or = 4
• Pregnancy
• Any condition precluding patient going home with in 24 hours of surgery
• Non-English speaking or inability to participate in the study
• Patients with coagulopathy or on therapeutic anticoagulation
• Chronic Steroid Use
• Narcotic Addiction

Sponsors & Collaborators

• Sharad Khetarpal: lead

Study Sites (1)

UPMC Presbyterian-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (9)

• 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.

  PMID: 18719448 BACKGROUND

• 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.

  PMID: 12552223 BACKGROUND

• 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.

  PMID: 20889937 BACKGROUND

• 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.

  PMID: 27513972 BACKGROUND

• 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.

  PMID: 28036319 BACKGROUND

• 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.

  PMID: 30386022 BACKGROUND

• 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.

  BACKGROUND

• Winnie AP, Ramamurthy S, Durrani Z, Radonjic R: Plexus blocks for lower extremity surgery: New answers to old problems. Anesth Review 1974; 1:11

  BACKGROUND

• 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.

  PMID: 33177220 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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.

Results Point of Contact

• Title: Sharad Khetarpal, MD
• Organization: University of Pittsburgh

khetarpalsk@upmc.edu

4126235020

Study Officials

• Sharad Khetarpal, MD

  Department of Anesthesiology, University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The person who perform the block will be unblinded. The participants and the outcomes assessor will be blinded to the treatment allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Lumbar plexus block vs Quadratus lumborum type 3 block

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 11, 2019
• Study Start: March 19, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: July 15, 2021
• Results First Posted: July 15, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)