Selective Tibial Nerve Block vs Local Infiltration Analgesia After Prothetic Knee Surgery

Not Applicable

Completed

• Conditions: Postoperative Pain; Knee Osteoarthritis
• Interventions: Drug: Ropivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.2% Injectable Solution

• Registration Number: NCT03698006
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral or saphenous nerves. Indeed, the posterior part of the knee is innervated by the sciatic nerve. This nerve is not routinely blocked as clinicians fear to produce a motor block of the leg that might impair the postoperative assessment. An analgesic alternative is the infiltration of the knee with local anesthetics performed by the surgeon. Recently a trial(1) demonstrated that a selective tibial nerve block provides an effective analgesia without a motor blockage when compared with a sciatic nerve block. The objective of this randomized controlled double-blinded trial is to assess whether a tibial nerve block is more effective for the postoperative pain than local infiltration analgesia when there are combined with an adductor canal block, without decreasing the functional parameters.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-05
• Study Start: 2021-02-12
• Primary Completion: 2022-01-31
• Study Completion: 2022-06-30
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-07
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient scheduled for a total knee arthroplasty under spinal block.
• Patient with a weight above 40kg.

Exclusion Criteria

• Patient with ASA IV status.
• Contraindication to spinal block, or peripheral nerve blocks.
• Neurological deficit of the lower limb.
• Patient with renal dysfunction.
• Patient with chronic pain, opioid consumption or alcohol consumption.
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tibial nerve block	Ropivacaine 0.5% Injectable Solution	Adductor canal and tibial nerve blocks performed by the anesthetist under ultrasound guidance before spinal block.
Local infiltration analgesia	Ropivacaine 0.2% Injectable Solution	Adductor canal block by the anesthetist under ultrasound guidance before spinal block. Infiltration of the knee by the surgeon with local anesthetic at the end of the surgery.

Primary Outcome Measures

Name	Time	Method
Total morphine consumption (mg)	24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Rate of postoperative nausea and vomiting	2 hours, 24 hours, 48 hours and 72 hours postoperatively	Yes/No
Quadriceps muscle strength (numeric scale, 1-5)	24hours, 48hours and 72hours postoperatively	1=no contraction, 5=normal strength
Analgesic duration (minutes)	Postoperative day 0	Time from the block to the first analgesic request
Complication of tibial nerve block	up to 1 week	Intravascular injection/hematoma/infection/Common peroneal nerve block
Total morphine consumption (mg)	2 hours, 48 hours and 72 hours postoperatively
Pain scores (numeric rating scale, 0-10) at rest and on movement	2 hours, 24 hours, 48 hours and 72 hours postoperatively	0= no pain, 10=the worst pain imaginable
Rate of prurit	2 hours, 24 hours, 48 hours and 72 hours postoperatively	Yes/No
Active flexion	24hours, 48hours and 72hours postoperatively	Flexion of the knee by the patient measured in degrees
Passive flexion	24hours, 48hours and 72hours postoperatively	Flexion of the knee by physiotherapist measured in degrees
Distance walked (meters)	24hours, 48hours and 72hours postoperatively
Length of stay in hospital	up to 14 days	Days

Trial Locations

Locations (1)

Eric Albrecht; 🇨🇭 Lausanne, English, Switzerland