Lumbar Plexus and Suprainguinal Fascia Iliaca Blocks For Total Hip Replacement

NCT03744065 | Completed

• 1 other identifier: OAIC1001/18
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The nerves from lumbar plexus (LP) are the current target to achieve analgesia after a total hip arthroplasty (THA). Lumbar plexus block (LPB) is an alternative that provides optimal postoperative analgesia. However, many adverse effects and complications have been reported due to its proximity to vital structures. Because of these shortcomings, an alternative to block the LP nerves is required. In a recent trial suprainguinal Fascia Iliaca Block (SFIB) was reported to provide reliable analgesia in THA. SFIB may carry a lower risk profile, however, no study has compared the efficacy of LPB and SFIB in this setting. Thus, this randomized trial is set out to compare US guided LPB and SFIB for analgesia after THA. The hypothesis is that both blocks would result in similar postoperative opioid (morphine) consumption at 24 hours and, therefore, designed the study as an equivalence trial.

Conditions

Hip Osteoarthritis; Pain, Acute; Pain, Postoperative; Opioid Use

Keywords

nerve block; fascia iliaca; hip replacement; lumbar plexus

Outcome Measures

Primary Outcomes (1)

• Morphine consumption over 24 hours

  Total morphine consumption over 24 hours post block

  24 hours post block

Secondary Outcomes (22)

• Performance time

  2 hours after surgery

• Number of needle passes

  2 hours after surgery

• Postoperative static pain at 3 hours after block

  3 hours after the block

• Postoperative static pain at 6 hours after block

  6 hours after the block

• Postoperative static pain at 12 hours after block

  12 hours after the block

Study Arms (2)

Lumbar plexus block

ACTIVE COMPARATOR

Patients randomized to receive an ultrasound-guided lumbar plexus block

Procedure: lumbar plexus block

Suprainguinal fascia iliaca block

EXPERIMENTAL

Patients randomized to receive an ultrasound-guided suprainguinal fascia iliaca block

Procedure: suprainguinal fascia iliaca block

Interventions

lumbar plexus block PROCEDURE

Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, in the posteromedial quadrant of psoas muscle

Lumbar plexus block

suprainguinal fascia iliaca block PROCEDURE

Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, underneath the fascia iliaca at the suprainguinal level

Suprainguinal fascia iliaca block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 80 years
• American Society of Anesthesiologists classification 1-3
• Body mass index between 20 and 35 (kg/m2)

You may not qualify if:

• Adults who are unable to give their own consent
• Pre-existing neuropathy (assessed by history and physical examination)
• Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
• Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
• Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
• Allergy to local anesthetics (LAs) or morphine
• Pregnancy
• Prior surgery in the corresponding side of the lumbar o suprainguinal area
• Chronic pain syndromes requiring opioid intake at home

Sponsors & Collaborators

• University of Chile: lead

Study Sites (1)

Hospital Clínico Universidad de Chile

Santiago, Santiago Metropolitan, 8380456, Chile

Location

Related Publications (18)

• Siddiqui ZI, Cepeda MS, Denman W, Schumann R, Carr DB. Continuous lumbar plexus block provides improved analgesia with fewer side effects compared with systemic opioids after hip arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):393-8. doi: 10.1016/j.rapm.2007.04.008.

  PMID: 17961837 BACKGROUND

• Klein SM, D'Ercole F, Greengrass RA, Warner DS. Enoxaparin associated with psoas hematoma and lumbar plexopathy after lumbar plexus block. Anesthesiology. 1997 Dec;87(6):1576-9. doi: 10.1097/00000542-199712000-00040. No abstract available.

  PMID: 9416746 BACKGROUND

• Aida S, Takahashi H, Shimoji K. Renal subcapsular hematoma after lumbar plexus block. Anesthesiology. 1996 Feb;84(2):452-5. doi: 10.1097/00000542-199602000-00027. No abstract available.

  PMID: 8602680 BACKGROUND

• Aveline C, Bonnet F. Delayed retroperitoneal haematoma after failed lumbar plexus block. Br J Anaesth. 2004 Oct;93(4):589-91. doi: 10.1093/bja/aeh242. Epub 2004 Aug 20.

  PMID: 15321930 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

• Gentili M, Aveline C, Bonnet F. [Total spinal anesthesia after posterior lumbar plexus block]. Ann Fr Anesth Reanim. 1998;17(7):740-2. doi: 10.1016/s0750-7658(98)80112-3. French.

  PMID: 9750813 BACKGROUND

• Pousman RM, Mansoor Z, Sciard D. Total spinal anesthetic after continuous posterior lumbar plexus block. Anesthesiology. 2003 May;98(5):1281-2. doi: 10.1097/00000542-200305000-00034. No abstract available.

  PMID: 12717153 BACKGROUND

• Duarte LT, Saraiva RA. [Total spinal block after posterior lumbar plexus blockade: case report.]. Rev Bras Anestesiol. 2006 Oct;56(5):518-23. doi: 10.1590/s0034-70942006000500010. Portuguese.

  PMID: 19468598 BACKGROUND

• Dogan Z, Bakan M, Idin K, Esen A, Uslu FB, Ozturk E. Total spinal block after lumbar plexus block: a case report. Braz J Anesthesiol. 2014 Mar-Apr;64(2):121-3. doi: 10.1016/j.bjane.2013.03.002. Epub 2013 Oct 11.

  PMID: 24794455 BACKGROUND

• Gadsden JC, Lindenmuth DM, Hadzic A, Xu D, Somasundarum L, Flisinski KA. Lumbar plexus block using high-pressure injection leads to contralateral and epidural spread. Anesthesiology. 2008 Oct;109(4):683-8. doi: 10.1097/ALN.0b013e31818631a7.

  PMID: 18813048 BACKGROUND

• Auroy Y, Benhamou D, Bargues L, Ecoffey C, Falissard B, Mercier FJ, Bouaziz H, Samii K. Major complications of regional anesthesia in France: The SOS Regional Anesthesia Hotline Service. Anesthesiology. 2002 Nov;97(5):1274-80. doi: 10.1097/00000542-200211000-00034.

  PMID: 12411815 BACKGROUND

• Dalens B, Vanneuville G, Tanguy A. Comparison of the fascia iliaca compartment block with the 3-in-1 block in children. Anesth Analg. 1989 Dec;69(6):705-13.

  PMID: 2589650 BACKGROUND

• Dolan J, Williams A, Murney E, Smith M, Kenny GN. Ultrasound guided fascia iliaca block: a comparison with the loss of resistance technique. Reg Anesth Pain Med. 2008 Nov-Dec;33(6):526-31. doi: 10.1016/j.rapm.2008.03.008.

  PMID: 19258967 BACKGROUND

• Kumar K, Pandey RK, Bhalla AP, Kashyap L, Garg R, Darlong V, Malhotra R, Yadav CS. Comparison of conventional infrainguinal versus modified proximal suprainguinal approach of Fascia Iliaca Compartment Block for postoperative analgesia in Total Hip Arthroplasty. A prospective randomized study. Acta Anaesthesiol Belg. 2015;66(3):95-100.

  PMID: 26767235 BACKGROUND

• Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.

  PMID: 21401544 BACKGROUND

• Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.

  PMID: 28059869 BACKGROUND

• Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.

  PMID: 26426575 BACKGROUND

• Arnuntasupakul V, Chalachewa T, Leurcharusmee P, Tiyaprasertkul W, Finlayson RJ, Tran DQ. Ultrasound with neurostimulation compared with ultrasound guidance alone for lumbar plexus block: A randomised single blinded equivalence trial. Eur J Anaesthesiol. 2018 Mar;35(3):224-230. doi: 10.1097/EJA.0000000000000736.

  PMID: 29135692 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Acute Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Daniela Bravo, MD

  University of Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 16, 2018
• Study Start: November 19, 2018
• Primary Completion: January 22, 2020
• Study Completion: January 23, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)