Clinical trial NCT02524652: Local Infiltration Analgesia vs Adductor Canal Block for Analgesia After Anterior Cruciate Ligament Reconstruction
Official title: Postoperative Analgesic Efficacy of Local Infiltration Analgesia Versus Adductor Canal Block After Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Double-blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rupture of Anterior Cruciate Ligament
Infiltration
Regional Anesthesia Morbidity
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total morphine consumption (mg)
timeFrame: 24 h postoperatively
Secondary outcomes:
measure: Total morphine consumption (mg)
timeFrame: 2 h postoperatively
measure: Total morphine consumption (mg)
timeFrame: 48 h postoperatively
measure: Total morphine consumption (mg)
timeFrame: 72 h postoperatively
measure: Pain scores (numeric rating scale, 0-10) at rest and on movement
timeFrame: 2 h postoperatively
measure: Pain scores (numeric rating scale, 0-10) at rest and on movement
timeFrame: 12 h postoperatively
measure: Pain scores (numeric rating scale, 0-10) at rest and on movement
timeFrame: 24 h postoperatively
measure: Pain scores (numeric rating scale, 0-10) at rest and on movement
timeFrame: 36 h postoperatively
measure: Pain scores (numeric rating scale, 0-10) at rest and on movement
timeFrame: 48 h postoperatively
measure: Pain scores (numeric rating scale, 0-10) at rest and on movement
timeFrame: 60 h postoperatively
measure: Pain scores (numeric rating scale, 0-10) at rest and on movement
timeFrame: 72 h postoperatively
measure: Postoperative nausea and vomiting (yes/no)
timeFrame: 24 h postoperatively
measure: Postoperative nausea and vomiting (yes/no)
timeFrame: 48 h postoperatively
measure: Postoperative nausea and vomiting (yes/no)
timeFrame: 72 h postoperatively
measure: Pruritus (yes/no)
timeFrame: 24 h postoperatively
measure: Pruritus (yes/no)
timeFrame: 48 h postoperatively
measure: Pruritus (yes/no)
timeFrame: 72 h postoperatively
measure: Active flexion
timeFrame: 24 h postoperatively
measure: Active flexion
timeFrame: 48 h postoperatively
measure: Active flexion
timeFrame: 72 h postoperatively
measure: Quadriceps muscle strength (numeric scale, 1-5)
timeFrame: 24 h postoperatively
measure: Quadriceps muscle strength (numeric scale, 1-5)
timeFrame: 48 h postoperatively
measure: Quadriceps muscle strength (numeric scale, 1-5)
timeFrame: 72 h postoperatively
measure: Distance walked (meters)
timeFrame: 24 h postoperatively
measure: Distance walked (meters)
timeFrame: 48 h postoperatively
measure: Distance walked (meters)
timeFrame: 72 h postoperatively
measure: Anterior Cruciate Ligament - Return to Sport after Injury scale
timeFrame: 4 months postoperatively
measure: Anterior cruciate ligament -Return to Sport after Injury scale
timeFrame: 8 months postoperatively
measure: International Knee Documentation Committee score
timeFrame: 4 months postoperatively
measure: International Knee Documentation Committee score
timeFrame: 8 months postoperatively
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
state: Vaud
Study officials:
affiliation: CHUV
name: Eric Albrecht, PD Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.