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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Eric Albrecht，Centre Hospitalier Universitaire Vaudois

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

November 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Total morphine consumption (mg)[ Time Frame: 24 hours postoperatively ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Optimal Pain Control After Prothetic Knee Surgery Either by Selective Tibial Nerve Block Versus Local Infiltration Analgesia

Brief Summary

Patient suffer from moderate posterior knee pain after TKA despite injection of local anesthetic around the femoral nerve (femoral nerve block). 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 a femoral nerve block, without decreasing the functional parameters.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: Ropivacaine 0.5% Injectable Solution
Tibial nerve block with 10ml of Ropivacaine 0.5%
Drug: Ropivacaine 0.2% Injectable Solution
Infiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule

Study Arms

Experimental: Tibial nerve block
Femoral nerve and tibial nerve blocks performed by the anesthetist under ultrasound guidance before spinal block.
Active Comparator: Local infiltration analgesia
Femoral nerve 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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 1, 2021

Estimated Primary Completion Date

November 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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, femoral nerve block or tibial nerve block. - Neurological deficit of the lower limb. - Patient with renal dysfunction. - Patient with chronic pain, opioid consumption or alcohol consumption. - Pregnancy.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Eric Albrecht，Centre Hospitalier Universitaire Vaudois

Study Sponsor ^ICMJE

Centre Hospitalier Universitaire Vaudois

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Centre Hospitalier Universitaire Vaudois

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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