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

NCT ID: NCT05728294

Last Updated: 2023-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups: femoral nerve block or sciatic nerve block with ropivacaine
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Femoral nerve block

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

Group Type ACTIVE_COMPARATOR

Femoral nerve block with ropivacaine 0.5%, 20 ml

Intervention Type PROCEDURE

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

Sciatic nerve block

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

Group Type EXPERIMENTAL

Sciatic nerve block with ropivacaine 0.5%, 20 ml

Intervention Type PROCEDURE

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

Interventions

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Femoral nerve block with ropivacaine 0.5%, 20 ml

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

Intervention Type PROCEDURE

Sciatic nerve block with ropivacaine 0.5%, 20 ml

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* proximal tibial osteotomy

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Eric Albrecht

Program Director, regional anaesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital of Lausanne

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 38134484 (View on PubMed)

Other Identifiers

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2018-01774

Identifier Type: -

Identifier Source: org_study_id

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