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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05728294
• Other study ID #: 2018-01774
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: March 31, 2023

Study information

• Verified date: April 2023
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 31, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Femoral nerve block with ropivacaine 0.5%, 20 ml
Femoral nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml
• Sciatic nerve block with ropivacaine 0.5%, 20 ml
Sciatic nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml

Locations

Country	Name	City	State
Switzerland	University Hospital of Lausanne	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

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