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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Femoral nerve block with ropivacaine 0.5%, 20 ml
Sciatic nerve block with ropivacaine 0.5%, 20 ml
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University Hospital of Lausanne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Femoral nerve block

Sciatic nerve block

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intravenous morphine consumption
Intravenous morphine consumption (mg)

Secondary Outcome Measures

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

Full Information

First Posted
January 19, 2023
Last Updated
April 20, 2023
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT05728294
Brief Title
Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy
Official Title
Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: femoral nerve block or sciatic nerve block with ropivacaine
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femoral nerve block
Arm Type
Active Comparator
Arm Description
Femoral nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL
Arm Title
Sciatic nerve block
Arm Type
Experimental
Arm Description
Sciatic nerve block performed under ultrasound guidance with ropivacaine 0.5%, 20mL
Intervention Type
Procedure
Intervention Name(s)
Femoral nerve block with ropivacaine 0.5%, 20 ml
Intervention Description
Femoral nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml
Intervention Type
Procedure
Intervention Name(s)
Sciatic nerve block with ropivacaine 0.5%, 20 ml
Intervention Description
Sciatic nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml
Primary Outcome Measure Information:
Title
Intravenous morphine consumption
Description
Intravenous morphine consumption (mg)
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Intravenous morphine consumption
Description
Intravenous morphine consumption (mg)
Time Frame
2 hours after surgery
Title
Intravenous morphine consumption
Description
Intravenous morphine consumption (mg)
Time Frame
48 hours after surgery
Title
rest pain score
Description
pain score at rest (visual analogue scale, 0-10)
Time Frame
2 hours after surgery
Title
rest pain score
Description
pain score at rest (visual analogue scale, 0-10)
Time Frame
24 hours after surgery
Title
rest pain score
Description
pain score at rest (visual analogue scale, 0-10)
Time Frame
48 hours after surgery
Title
dynamic pain score
Description
pain score on movement (visual analogue scale, 0-10)
Time Frame
2 hours after surgery
Title
dynamic pain score
Description
pain score on movement (visual analogue scale, 0-10)
Time Frame
24 hours after surgery
Title
dynamic pain score
Description
pain score on movement (visual analogue scale, 0-10)
Time Frame
48 hours after surgery
Title
Rate of postoperative nausea and vomiting
Description
number of events/total number of patients
Time Frame
2 hours after surgery
Title
Rate of postoperative nausea and vomiting
Description
number of events/total number of patients
Time Frame
24 hours after surgery
Title
Rate of postoperative nausea and vomiting
Description
number of events/total number of patients
Time Frame
48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
University Hospital of Lausanne
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

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

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