Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy

NCT05728294 | Completed

• 1 other identifier: 2018-01774
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Proximal tibial osteotomy is associated with moderate to severe postoperative pain. The proximal part of the tibia is innervated by branches from the femoral nerve anteriorly and the sciatic nerve posteriorly. Little is known on the type of peripheral nerve block to perform so that optimal postoperative analgesia is provided with minimum impact on the motor function. This randomised controlled double-blinded trial tested the hypothesis that a femoral nerve block provides superior analgesia than a sciatic nerve block after proximal tibial osteotomy.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Intravenous morphine consumption

  Intravenous morphine consumption (mg)

  24 hours after surgery

Secondary Outcomes (11)

• Intravenous morphine consumption

  2 hours after surgery

• Intravenous morphine consumption

  48 hours after surgery

• rest pain score

  2 hours after surgery

• rest pain score

  24 hours after surgery

• rest pain score

  48 hours after surgery

Study Arms (2)

Femoral nerve block

ACTIVE COMPARATOR

Femoral nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL

Procedure: Femoral nerve block with ropivacaine 0.5%, 20 ml

Sciatic nerve block

EXPERIMENTAL

Sciatic nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL

Procedure: Sciatic nerve block with ropivacaine 0.5%, 20 ml

Interventions

Femoral nerve block with ropivacaine 0.5%, 20 ml PROCEDURE

Femoral nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml

Femoral nerve block

Sciatic nerve block with ropivacaine 0.5%, 20 ml PROCEDURE

Sciatic nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml

Sciatic nerve block

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• proximal tibial osteotomy

You may not qualify if:

• femoral or sciatic nerve deficit,
• pre-existing peripheral neuropathy,
• chronic pain diagnosis,
• pregnancy,
• identified contraindications to peripheral nerve block (e.g., local anesthetic allergy, coagulopathy, or infection at the block site).

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

University Hospital of Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• Kull C, Martin R, Rossel JB, Nguyen A, Albrecht E. Femoral vs sciatic nerve block to provide analgesia after medial open wedge high tibial osteotomy in the setting of multimodal analgesia: A randomized, controlled, single-blinded trial. J Clin Anesth. 2024 May;93:111355. doi: 10.1016/j.jclinane.2023.111355. Epub 2023 Dec 21.

  PMID: 38134484 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director, regional anaesthesia

Model Details: Two groups: femoral nerve block or sciatic nerve block with ropivacaine

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 15, 2023
• Study Start: February 1, 2019
• Primary Completion: October 31, 2022
• Study Completion: March 31, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

CH (1)