Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery

Study Overview
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Brief Summary
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The goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor canal block to the standard pain regiment after anterior cruciate ligament surgery

Detailed Description
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Patients scheduled for anterior cruciate ligament surgery will be randomized in an intervention and control group following informed consent. Before surgery, patients will receive an adductor canal bock with Levobupivacaine (intervention group) or 0.9% saline (control group). Following surgery, pain intensity, analgesic consumption and pain satisfaction will be recorded bij patients in a diary for 48 hours.

Official Title
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Efficacy of Adductor Canal Block for Anterior Cruciate Ligament Surgery: A Prospective Double Blinded Randomized Controlled Trial

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Procedure: Adductor canal block
* Drug: Levobupivacaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Undergoing anterior cruciate ligament surgery under general anesthesia ASA I-III Exclusion Criteria: Contraindication for locoregional anesthesia; infection at the target puncture site, allergy to local anesthetics, Neuromuscular disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients are randomized to receive an intervention (nerve block) with either an active drug or placebo.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levobupivacaine<br>Intervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound | Procedure: Adductor canal block<br>* Before anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound.<br>Drug: Levobupivacaine<br>* Levobupivacaine<br>|
| Placebo Comparator: Placebo<br>Control group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound | Procedure: Adductor canal block<br>* Before anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound.<br>Drug: Placebo<br>* 10 ml of sodium chloride 0.9%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain level | Using Numerical Rating Scales for pain from 1 to 10, 1 is no pain, 10 is the worst pain you can imagine | Within first 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate use | postoperative use of opiates (Morphine equivalent dose (mg)) | Within first 48 hours after surgery | 
| Nausea | Postoperative nausea (yes/no) | Within first 48 hours after surgery | 
| Block result | If there's any loss of motor function (no quadriceps paresis, partial quadriceps paresis, complete quadriceps paresis.) using bromage score | within first 24 hours after surgery | 
| Patient satisfaction | Using Numerical Rating Scales from 1 to 10, 1 is not satisfied at all, 10 is completely satisfied | 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adductor canal block