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

NCT03698006 | Completed DMC

• 1 other identifier: CER 2018-01080
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption (mg)

  24 hours postoperatively

Secondary Outcomes (11)

• Total morphine consumption (mg)

  2 hours, 48 hours and 72 hours postoperatively

• Analgesic duration (minutes)

  Postoperative day 0

• Pain scores (numeric rating scale, 0-10) at rest and on movement

  2 hours, 24 hours, 48 hours and 72 hours postoperatively

• Rate of postoperative nausea and vomiting

  2 hours, 24 hours, 48 hours and 72 hours postoperatively

• Rate of prurit

  2 hours, 24 hours, 48 hours and 72 hours postoperatively

Study Arms (2)

Tibial nerve block

EXPERIMENTAL

Adductor canal and tibial nerve blocks performed by the anesthetist under ultrasound guidance before spinal block.

Drug: Ropivacaine 0.5% Injectable Solution

Local infiltration analgesia

ACTIVE COMPARATOR

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

Interventions

Ropivacaine 0.5% Injectable Solution DRUG

Tibial nerve block with 10ml of Ropivacaine 0.5%

Tibial nerve block

Ropivacaine 0.2% Injectable Solution DRUG

Infiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule

Local infiltration analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Eric Albrecht

Lausanne, English, 1004, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 22543069 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Osteoarthritis, Knee

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program director of regional anaesthesia

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 5, 2018
• Study Start: February 12, 2021
• Primary Completion: January 31, 2022
• Study Completion: June 30, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

CH (1)