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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Femoral nerve block with ropivacaine 0.5%, 20 ml; Procedure: Sciatic nerve block with ropivacaine 0.5%, 20 ml

• Registration Number: NCT05728294
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2022-10-31
• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-02-11
• Study First Posted: 2023-02-15
• Study Completion: 2023-03-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-20
• Last Update Posted: 2023-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral nerve block	Femoral nerve block with ropivacaine 0.5%, 20 ml	Femoral nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL
Sciatic nerve block	Sciatic nerve block with ropivacaine 0.5%, 20 ml	Sciatic nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL

Primary Outcome Measures

Name	Time	Method
Intravenous morphine consumption	24 hours after surgery	Intravenous morphine consumption (mg)

Secondary Outcome Measures

Name	Time	Method
Intravenous morphine consumption	48 hours after surgery	Intravenous morphine consumption (mg)
rest pain score	48 hours after surgery	pain score at rest (visual analogue scale, 0-10)
dynamic pain score	48 hours after surgery	pain score on movement (visual analogue scale, 0-10)
Rate of postoperative nausea and vomiting	48 hours after surgery	number of events/total number of patients

Trial Locations

Locations (1)

University Hospital of Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland