Local Infiltration Analgesia vs Adductor Canal Block for Analgesia After Anterior Cruciate Ligament Reconstruction

Overview

Early rehabilitation after anterior cruciate ligament reconstruction is of paramount importance and requires optimal pain control based on a multimodal concept, including injection of local anaesthetics. Regarding this latter, different options have emerged recently such as the adductor canal block, performed before the surgery by the anaesthesiologist or the infiltration of the articulation performed by the surgeon at the of the intervention. No trial has compared these two approaches. As practice of medicine should be based on evidence, we decided to undertake this randomised controlled trial where we compared the adductor canal block with the local infiltration analgesia technique in terms of pain and functional outcomes

Full Title of Study: “Postoperative Analgesic Efficacy of Local Infiltration Analgesia Versus Adductor Canal Block After Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Double-blinded Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: March 2018

Detailed Description

Patients scheduled to undergo anterior cruciate ligament reconstruction under general anaesthesia will be randomly allocated to two groups: local infiltration analgesia or adductor canal block. The local infiltration analgesia will be performed by the surgeon at the end of surgery with 20 mLs of ropivacaine 0.5%. The adductor canal block will be performed by the anaesthesiologist under ultrasound guidance after the surgery, before awaking the patient, using the same solution (20 mLs ropivacaine 0.5%) Postoperative analgesia will include intravenous patient-controlled analgesia of morphine (settings 1 mg/ml, 2 ml/10 minutes, 40 mg/4 hours), ibuprofen (3×400 mg) and acetaminophen (4×1000 mg). A research assistant and a physiotherapist, both blinded to the group allocation, will collect pain and rehabilitation data, respectively.

Interventions

  • Drug: Ropivacaine 0.5% 20 mLs
    • Injection of the local anesthetic at the end of surgery, either in the surgical sites by the surgeon, or in the adductor canal block by the anesthesiologist under ultrasound guidance.

Arms, Groups and Cohorts

  • Experimental: Local infiltration analgesia
    • Infiltration of the knee by the surgeon with local anaesthetics under general anaesthesia.
  • Active Comparator: Adductor canal block
    • Injection of local anaesthetics under ultrasound guidance in the adductor canal by the anaesthesiologist after the surgery, before awaking the patient.

Clinical Trial Outcome Measures

Primary Measures

  • Total morphine consumption (mg)
    • Time Frame: 24 h postoperatively

Secondary Measures

  • Total morphine consumption (mg)
    • Time Frame: 2 h postoperatively
  • Total morphine consumption (mg)
    • Time Frame: 48 h postoperatively
  • Total morphine consumption (mg)
    • Time Frame: 72 h postoperatively
  • Pain scores (numeric rating scale, 0-10) at rest and on movement
    • Time Frame: 2 h postoperatively
  • Pain scores (numeric rating scale, 0-10) at rest and on movement
    • Time Frame: 12 h postoperatively
  • Pain scores (numeric rating scale, 0-10) at rest and on movement
    • Time Frame: 24 h postoperatively
  • Pain scores (numeric rating scale, 0-10) at rest and on movement
    • Time Frame: 36 h postoperatively
  • Pain scores (numeric rating scale, 0-10) at rest and on movement
    • Time Frame: 48 h postoperatively
  • Pain scores (numeric rating scale, 0-10) at rest and on movement
    • Time Frame: 60 h postoperatively
  • Pain scores (numeric rating scale, 0-10) at rest and on movement
    • Time Frame: 72 h postoperatively
  • Postoperative nausea and vomiting (yes/no)
    • Time Frame: 24 h postoperatively
  • Postoperative nausea and vomiting (yes/no)
    • Time Frame: 48 h postoperatively
  • Postoperative nausea and vomiting (yes/no)
    • Time Frame: 72 h postoperatively
  • Pruritus (yes/no)
    • Time Frame: 24 h postoperatively
  • Pruritus (yes/no)
    • Time Frame: 48 h postoperatively
  • Pruritus (yes/no)
    • Time Frame: 72 h postoperatively
  • Active flexion
    • Time Frame: 24 h postoperatively
    • Flexion of the knee by the patient measured in degrees
  • Active flexion
    • Time Frame: 48 h postoperatively
    • Flexion of the knee by the patient measured in degrees
  • Active flexion
    • Time Frame: 72 h postoperatively
    • Flexion of the knee by the patient measured in degrees
  • Quadriceps muscle strength (numeric scale, 1-5)
    • Time Frame: 24 h postoperatively
  • Quadriceps muscle strength (numeric scale, 1-5)
    • Time Frame: 48 h postoperatively
  • Quadriceps muscle strength (numeric scale, 1-5)
    • Time Frame: 72 h postoperatively
  • Distance walked (meters)
    • Time Frame: 24 h postoperatively
  • Distance walked (meters)
    • Time Frame: 48 h postoperatively
  • Distance walked (meters)
    • Time Frame: 72 h postoperatively
  • Anterior Cruciate Ligament – Return to Sport after Injury scale
    • Time Frame: 4 months postoperatively
  • Anterior cruciate ligament -Return to Sport after Injury scale
    • Time Frame: 8 months postoperatively
  • International Knee Documentation Committee score
    • Time Frame: 4 months postoperatively
  • International Knee Documentation Committee score
    • Time Frame: 8 months postoperatively

Participating in This Clinical Trial

Inclusion Criteria

  • patients from 18 to 50 years old scheduled to undergo anterior cruciate ligament reconstruction Exclusion Criteria:

  • peripheral neuropathy – pre-existing femoral neuropathy – diabetes mellitus – alcoholism – drug addiction – cancer with chemotherapy – chronic pain state

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire Vaudois
  • Provider of Information About this Clinical Study
    • Principal Investigator: Eric Albrecht, Program Director, Regional Anaesthesia – Centre Hospitalier Universitaire Vaudois
  • Overall Official(s)
    • Eric Albrecht, PD Dr, Principal Investigator, CHUV

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