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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rupture of Anterior Cruciate Ligament, Infiltration, Regional Anesthesia Morbidity

Intervention / Treatment
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* Drug: Ropivacaine 0.5% 20 mLs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local infiltration analgesia<br>Infiltration of the knee by the surgeon with local anaesthetics under general anaesthesia. | Drug: Ropivacaine 0.5% 20 mLs<br>* 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.<br>* Other names: Naropine, Naropin;|
| Active Comparator: Adductor canal block<br>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<br>* 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.<br>* Other names: Naropine, Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |