QL vs LP Blocks for Analgesia Following THA

NCT04402437 | Completed DMC

• 1 other identifier: Pro00098482
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Evaluate difference in postoperative opioid consumption when subjects receive a quadratus lumborum (QL) or lumbar plexus (LP) block preoperatively for total hip arthroplasty (THA). Hypothesis: Preoperative QL and LP blocks will result in similar postoperative opioid consumption following hip arthroplasty.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Opioid consumption including intraoperative consumption

  12 hours

Secondary Outcomes (1)

• Opioid consumption 8 hours postoperative

  8 hours

Study Arms (2)

Receives LP Block

ACTIVE COMPARATOR

Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement.

Procedure: LP Block

Receives QL Block

ACTIVE COMPARATOR

Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine skin wheal that will be placed after ultrasound identification of external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement. Local anesthetic injection will also be observed with real time ultrasound guidance.

Procedure: QL Block

Interventions

LP Block PROCEDURE

Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement.

Receives LP Block

QL Block PROCEDURE

Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine skin wheal that will be placed after ultrasound identification of external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement. Local anesthetic injection will also be observed with real time ultrasound guidance.

Receives QL Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years-old
• Undergoing elective hip arthroplasty.

You may not qualify if:

• Local anesthetic allergy
• Chlorhexidine allergy
• Subjects with a weight less than 40kg
• Subjects that are unable or choose not to give informed consent
• Emergency surgery
• Known preoperative substance abuse
• Allergy to all opioids

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (19)

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  PMID: 15118039 BACKGROUND

• Singh JA, Lewallen D. Predictors of pain and use of pain medications following primary Total Hip Arthroplasty (THA): 5,707 THAs at 2-years and 3,289 THAs at 5-years. BMC Musculoskelet Disord. 2010 May 13;11:90. doi: 10.1186/1471-2474-11-90.

  PMID: 20462458 BACKGROUND

• Becchi C, Al Malyan M, Coppini R, Campolo M, Magherini M, Boncinelli S. Opioid-free analgesia by continuous psoas compartment block after total hip arthroplasty. A randomized study. Eur J Anaesthesiol. 2008 May;25(5):418-23. doi: 10.1017/S026502150700302X. Epub 2007 Nov 21.

  PMID: 18028577 BACKGROUND

• Biboulet P, Morau D, Aubas P, Bringuier-Branchereau S, Capdevila X. Postoperative analgesia after total-hip arthroplasty: Comparison of intravenous patient-controlled analgesia with morphine and single injection of femoral nerve or psoas compartment block. a prospective, randomized, double-blind study. Reg Anesth Pain Med. 2004 Mar-Apr;29(2):102-9. doi: 10.1016/j.rapm.2003.11.006.

  PMID: 15029544 BACKGROUND

• Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anaesthesia improve outcome after total hip arthroplasty? A systematic review. Br J Anaesth. 2009 Sep;103(3):335-45. doi: 10.1093/bja/aep208. Epub 2009 Jul 23.

  PMID: 19628483 BACKGROUND

• Stevens RD, Van Gessel E, Flory N, Fournier R, Gamulin Z. Lumbar plexus block reduces pain and blood loss associated with total hip arthroplasty. Anesthesiology. 2000 Jul;93(1):115-21. doi: 10.1097/00000542-200007000-00021.

  PMID: 10861154 BACKGROUND

• Harvey NR, Wolf BJ, Bolin ED, Wilson SH. Comparison of analgaesia with lumbar epidurals and lumbar plexus nerve blocks in patients receiving multimodal analgaesics following primary total hip arthroplasty: a retrospective analysis. Int Orthop. 2017 Nov;41(11):2229-2235. doi: 10.1007/s00264-017-3465-7. Epub 2017 Apr 11.

  PMID: 28396932 BACKGROUND

• Wilson SH, Wolf BJ, Algendy AA, Sealy C, Demos HA, McSwain JR. Comparison of Lumbar Epidurals and Lumbar Plexus Nerve Blocks for Analgesia Following Primary Total Hip Arthroplasty: A Retrospective Analysis. J Arthroplasty. 2017 Feb;32(2):635-640. doi: 10.1016/j.arth.2016.07.042. Epub 2016 Aug 10.

  PMID: 27597428 BACKGROUND

• Wilson SH, Auroux AS, Eloy JD, Merman RB, Chelly JE. Ropivacaine 0.1% versus 0.2% for continuous lumbar plexus nerve block infusions following total hip arthroplasty: a randomized, double blinded study. Pain Med. 2014 Mar;15(3):465-72. doi: 10.1111/pme.12309. Epub 2013 Dec 11.

  PMID: 24330381 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

• Johnston DF, Sondekoppam RV. Continuous quadratus lumborum block analgesia for total hip arthroplasty revision. J Clin Anesth. 2016 Dec;35:235-237. doi: 10.1016/j.jclinane.2016.08.002. Epub 2016 Sep 26. No abstract available.

  PMID: 27871532 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

• La Colla L, Uskova A, Ben-David B. Single-shot Quadratus Lumborum Block for Postoperative Analgesia After Minimally Invasive Hip Arthroplasty: A New Alternative to Continuous Lumbar Plexus Block? Reg Anesth Pain Med. 2017 Jan/Feb;42(1):125-126. doi: 10.1097/AAP.0000000000000523. No abstract available.

  PMID: 27997495 BACKGROUND

• Ueshima H, Yoshiyama S, Otake H. RETRACTED: The ultrasound-guided continuous transmuscular quadratus lumborum block is an effective analgesia for total hip arthroplasty. J Clin Anesth. 2016 Jun;31:35. doi: 10.1016/j.jclinane.2015.12.033. Epub 2016 Mar 22.

  PMID: 27185672 BACKGROUND

• Hansen CK, Dam M, Bendtsen TF, Borglum J. Ultrasound-Guided Quadratus Lumborum Blocks: Definition of the Clinical Relevant Endpoint of Injection and the Safest Approach. A A Case Rep. 2016 Jan 15;6(2):39. doi: 10.1213/XAA.0000000000000270. No abstract available.

  PMID: 26771297 BACKGROUND

• Capdevila X, Macaire P, Dadure C, Choquet O, Biboulet P, Ryckwaert Y, D'Athis F. Continuous psoas compartment block for postoperative analgesia after total hip arthroplasty: new landmarks, technical guidelines, and clinical evaluation. Anesth Analg. 2002 Jun;94(6):1606-13, table of contents. doi: 10.1097/00000539-200206000-00045.

  PMID: 12032037 BACKGROUND

• Kelly T, Wolla CD, Wolf BJ, Hay E, Babb S, Wilson SH. Comparison of lateral quadratus lumborum and lumbar plexus blocks for postoperative analgesia following total hip arthroplasty: a randomized clinical trial. Reg Anesth Pain Med. 2022 Sep;47(9):541-546. doi: 10.1136/rapm-2022-103598. Epub 2022 Jun 10.

  PMID: 35688515 DERIVED

Study Officials

• Sylvia H Wilson, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: All subjects will be positioned, prepped and sedated for the randomized regional anesthesia procedure in the preoperative holding area. The subject will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the subject will receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in their nerve block regardless of randomization. The relevant anatomy will then be identified using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum block). Surface anatomy will be marked with a marking pen for both groups to keep the intraoperative and surgical team blinded. The skin will be cleaned with chlorhexidine. Subject, surgeon, intraoperative anesthesia team and data collectors would all be blinded to the allocated group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The subject will be positioned in the lateral decubitus position with the operative side up and pulse oximetry and blood pressure cuff placed for monitoring. As part of routine care, the subject will receive sedation for their comfort. All subjects would receive 20 ml of 0.5% ropivacaine in their nerve block regardless of randomization. The relevant anatomy will then be identified using either surface landmarks (lumbar plexus block) or an ultrasound (quadratus lumborum block). Surface anatomy will be marked with a marking pen for both groups to keep the intraoperative and surgical team blinded. The skin will be cleaned with chlorhexidine.

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: July 23, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: August 2, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)