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

Study Overview
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Femoral nerve block with ropivacaine 0.5%, 20 ml
* Procedure: Sciatic nerve block with ropivacaine 0.5%, 20 ml


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups: femoral nerve block or sciatic nerve block with ropivacaine
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Femoral nerve block<br>Femoral nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL | Procedure: Femoral nerve block with ropivacaine 0.5%, 20 ml<br>* Femoral nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml<br>|
| Experimental: Sciatic nerve block<br>Sciatic nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL | Procedure: Sciatic nerve block with ropivacaine 0.5%, 20 ml<br>* Sciatic nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravenous morphine consumption | Intravenous morphine consumption (mg) | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravenous morphine consumption | Intravenous morphine consumption (mg) | 2 hours after surgery | 
| Intravenous morphine consumption | Intravenous morphine consumption (mg) | 48 hours after surgery | 
| rest pain score | pain score at rest (visual analogue scale, 0-10) | 2 hours after surgery | 
| rest pain score | pain score at rest (visual analogue scale, 0-10) | 24 hours after surgery | 
| rest pain score | pain score at rest (visual analogue scale, 0-10) | 48 hours after surgery | 
| dynamic pain score | pain score on movement (visual analogue scale, 0-10) | 2 hours after surgery | 
| dynamic pain score | pain score on movement (visual analogue scale, 0-10) | 24 hours after surgery | 
| dynamic pain score | pain score on movement (visual analogue scale, 0-10) | 48 hours after surgery | 
| Rate of postoperative nausea and vomiting | number of events/total number of patients | 2 hours after surgery | 
| Rate of postoperative nausea and vomiting | number of events/total number of patients | 24 hours after surgery | 
| Rate of postoperative nausea and vomiting | number of events/total number of patients | 48 hours after surgery |