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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Femoral nerve block with ropivacaine 0.5%, 20 ml; Procedure: Sciatic nerve block with ropivacaine 0.5%, 20 ml

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • University Hospital of Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Femoral nerve block; Femoral nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL	Procedure: Femoral nerve block with ropivacaine 0.5%, 20 ml; Femoral nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml
Experimental: Sciatic nerve block; Sciatic nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL	Procedure: Sciatic nerve block with ropivacaine 0.5%, 20 ml; Sciatic nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: February 11, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2018-01774

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No