The Efficacy of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction

Study Overview
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Brief Summary
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The Purpose of this study is to determine whether Adductor-Canal-Block is superior to placebo when it comes to analgetic efficacy after reconstruction of the anterior cruciate ligament.

Official Title
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The Effect of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction in Day Case Surgery

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Procedure: Ropivacain
* Procedure: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years Reconstruction of Anterior Cruciate Ligament Written consent ASA I-II BMI 19-35 Exclusion Criteria: Unable to communicate in Danish Allergic reactions toward drugs used in the trial Pregnancy Abuse of alcohol/drugs Daily opioid intake Infection at injection site Can not be mobilised to 5 meters of walk; pre-surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adductor-Canal-Block, Ropivacain<br>25 patients. ACB. 30 mL Ropivacain 7,5 mg/mL. Ultrasound-guided application. | Procedure: Ropivacain<br>* Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.<br>* Other names: Naropin;|
| Placebo Comparator: Adductor Canal Block, Placebo (saline)<br>25 patients. ACB. 30 mL Saline. Ultrasound-guided application. | Procedure: Saline<br>* Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain-score (VAS), patient standing | Pain-score messured on a Visual Analog Scale (VAS) 2 hours after adductor canal block. Patient standing. Intervention-group vs. placebo-group. | 2 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Opioid-consumption | ACB-group vs. placebo-group | 0-24 hours postoperative | 
| Postoperative Nausea and Vomiting | Levels of nausea (0-3). ACB-group vs. placebo-group | 0 hour postoperative | 
| Postoperative ondansetron consumption |  | In hospital | 
| Pain-score (VAS), patient at rest | ACB-group vs. placebo | 0 hours postoperative | 
| Pain-score (VAS), patient at rest | ACB-group vs. placebo | 1 hour postoperative | 
| Pain-score (VAS), patient at rest | ACB-group vs. placebo | 2 hours postoperative | 
| Pain-score (VAS), patient at rest | ACB-group vs. placebo | 4 hours postoperative | 
| Pain-score (VAS), patient at rest | ACB-group vs. placebo | 6 hours postoperative | 
| Pain-score (VAS), patient at rest | ACB-group vs. placebo | 8 hours postoperative | 
| Pain-score (VAS), patient at rest | ACB-group vs. placebo | 24 hours postoperative | 
| Pain-score (VAS), patient standing | ACB-group vs. placebo | 1 hour postoperative | 
| Pain-score (VAS), patient standing | ACB-group vs. placebo | 2 hours postoperative | 
| Pain-score (VAS), patient standing | ACB-group vs. placebo | 4 hours postoperative | 
| Pain-score (VAS), patient standing | ACB-group vs. placebo | 6 hours postoperative | 
| Pain-score (VAS), patient standing | ACB-group vs. placebo | 8 hours postoperative | 
| Pain-score (VAS), patient standing | ACB-group vs. placebo | 24 hours postoperative | 
| Pain-score (VAS), after 5 meters of walk | ACB-group vs. placebo | 2 hours postoperative | 
| Pain-score (VAS), after 5 meters of walk | ACB-group vs. placebo | 4 hours postoperative | 
| Pain-score (VAS), after 5 meters of walk | ACB-group vs. placebo | 6 hours postoperative | 
| Pain-score (VAS), after 5 meters of walk | ACB-group vs. placebo | 8 hours postoperative | 
| Pain-score (VAS), after 5 meters of walk | ACB-group vs. placebo | 24 hours postoperative | 
| Postoperative Nausea and Vomiting | Levels of nausea (0-3). ACB-group vs. placebo-group | 1 hours postoperative | 
| Postoperative Nausea and Vomiting | Levels of nausea (0-3). ACB-group vs. placebo-group | 2 hours postoperative | 
| Postoperative Nausea and Vomiting | Levels of nausea (0-3). ACB-group vs. placebo-group | 4 hours postoperative | 
| Postoperative Nausea and Vomiting | Levels of nausea (0-3). ACB-group vs. placebo-group | 6 hours postoperative | 
| Postoperative Nausea and Vomiting | Levels of nausea (0-3). ACB-group vs. placebo-group | 8 hours postoperative | 
| Postoperative Nausea and Vomiting | Levels of nausea (0-3). ACB-group vs. placebo-group | 24 hours postoperative | 
| Sedation | Levels of sedation (0-3). ACB-group vs. placebo | 0, hour postoperative | 
| Sedation | Levels of sedation (0-3). ACB-group vs. placebo | 1 hour postoperative | 
| Sedation | Levels of sedation (0-3). ACB-group vs. placebo | 2 hours postoperative | 
| Sedation | Levels of sedation (0-3). ACB-group vs. placebo | 4 hours postoperative | 
| Sedation | Levels of sedation (0-3). ACB-group vs. placebo | 6 hours postoperative | 
| Sedation | Levels of sedation (0-3). ACB-group vs. placebo | 8 hours postoperative | 
| Sedation | Levels of sedation (0-3). ACB-group vs. placebo | 24 hours postoperative | 
| Postoperative Nausea and Vomiting | Levels of nausea (0-3). ACB-group vs. placebo-group | 0 hours postoperative | 
| Pain (VAS) at rest, 0-24 hours postoperative (AUC) | Pain-score messured on a Visual Analog Scale (VAS) 0-24 hours after adductor canal block (AUC). Patient at rest. Intervention-group vs. placebo-group. | 0-24 h postoperative | 
| Pain (VAS), patient standing, 1-24 hours postoperative (AUC) | Pain-score messured on a Visual Analog Scale (VAS) 1-24 hours after adductor canal block (AUC). Patient standing. Intervention-group vs. placebo-group. | 1-24 hours postoperative | 
| Pain (VAS), pain after 5 meters of walk, 2-24 hours postoperative (AUC) | Pain-score messured on a Visual Analog Scale (VAS) 2-24 hours after adductor canal block (AUC). Pain after 5 meters of walk. Intervention-group vs. placebo-group. | 2-24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adductor Canal Block (ACB), Anterior Cruciate Ligament (ACL) Reconstruction, Saphenous nerve, Pain, Ultrasound block