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

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

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

Study Overview

• Status: Completed
• Conditions: Regional Anesthesia Morbidity; Rupture of Anterior Cruciate Ligament; Infiltration
• Intervention / Treatment: Drug: Ropivacaine 0.5% 20 mLs

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 (3x400 mg) and acetaminophen (4x1000 mg).

A research assistant and a physiotherapist, both blinded to the group allocation, will collect pain and rehabilitation data, respectively.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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: Local infiltration analgesia; Infiltration of the knee by the surgeon with local anaesthetics under general anaesthesia.	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.; Other Names: Naropine, Naropin
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.	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.; Other Names: Naropine, Naropin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Eric Albrecht, PD Dr, CHUV

Publications and helpful links

General Publications

• Stebler K, Martin R, Kirkham KR, Lambert J, De Sede A, Albrecht E. Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial. Br J Anaesth. 2019 Aug;123(2):e343-e349. doi: 10.1016/j.bja.2019.04.053. Epub 2019 May 24.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: August 6, 2015
• First Submitted That Met QC Criteria: August 13, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Actual): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: CER 193-15