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

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Knee Osteoarthritis
• Intervention / Treatment: Drug: Ropivacaine 0.5% Injectable Solution; Drug: Ropivacaine 0.2% Injectable Solution

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • English
    • Lausanne, English, Switzerland, 1004
      • Eric Albrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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
Experimental: Tibial nerve block; Adductor canal and tibial nerve blocks performed by the anesthetist under ultrasound guidance before spinal block.	Drug: Ropivacaine 0.5% Injectable Solution; Tibial nerve block with 10ml of Ropivacaine 0.5%
Active Comparator: Local infiltration analgesia; 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.	Drug: Ropivacaine 0.2% Injectable Solution; Infiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total morphine consumption (mg)	24 hours postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois

Publications and helpful links

General Publications

• Sinha SK, Abrams JH, Arumugam S, D'Alessio J, Freitas DG, Barnett JT, Weller RS. Femoral nerve block with selective tibial nerve block provides effective analgesia without foot drop after total knee arthroplasty: a prospective, randomized, observer-blinded study. Anesth Analg. 2012 Jul;115(1):202-6. doi: 10.1213/ANE.0b013e3182536193. Epub 2012 Apr 27.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 5, 2018

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine
• Other Study ID Numbers: CER 2018-01080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No