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

Sponsor
Centre Hospitalier Universitaire Vaudois (Other)
Overall Status
Recruiting
CT.gov ID
NCT03698006
Collaborator
(none)
60
1
2
23.6
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ropivacaine 0.5% Injectable Solution
  • Drug: Ropivacaine 0.2% Injectable Solution
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Optimal Pain Control After Prothetic Knee Surgery Either by Selective Tibial Nerve Block Versus Local Infiltration Analgesia
Actual Study Start Date :
Feb 12, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Total morphine consumption (mg) [24 hours postoperatively]

Secondary Outcome Measures

  1. Total morphine consumption (mg) [2 hours, 48 hours and 72 hours postoperatively]

  2. Analgesic duration (minutes) [Postoperative day 0]

    Time from the block to the first analgesic request

  3. 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

  4. Rate of postoperative nausea and vomiting [2 hours, 24 hours, 48 hours and 72 hours postoperatively]

    Yes/No

  5. Rate of prurit [2 hours, 24 hours, 48 hours and 72 hours postoperatively]

    Yes/No

  6. Active flexion [24hours, 48hours and 72hours postoperatively]

    Flexion of the knee by the patient measured in degrees

  7. Passive flexion [24hours, 48hours and 72hours postoperatively]

    Flexion of the knee by physiotherapist measured in degrees

  8. Quadriceps muscle strength (numeric scale, 1-5) [24hours, 48hours and 72hours postoperatively]

    1=no contraction, 5=normal strength

  9. Distance walked (meters) [24hours, 48hours and 72hours postoperatively]

  10. Complication of tibial nerve block [up to 1 week]

    Intravascular injection/hematoma/infection/Common peroneal nerve block

  11. Length of stay in hospital [up to 14 days]

    Days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eric Albrecht Lausanne English Switzerland 1004

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Vaudois

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Eric Albrecht, Program director of regional anaesthesia, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT03698006
Other Study ID Numbers:
  • CER 2018-01080
First Posted:
Oct 5, 2018
Last Update Posted:
Mar 31, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 31, 2022