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

Phase 4

Completed

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Procedure: Ropivacain; Procedure: Saline

• Registration Number: NCT01212666
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-09-30
• Study First Posted: 2010-10-01
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-09
• Last Update Posted: 2012-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adductor-Canal-Block, Ropivacain	Ropivacain	25 patients. ACB. 30 mL Ropivacain 7,5 mg/mL. Ultrasound-guided application.
Adductor Canal Block, Placebo (saline)	Saline	25 patients. ACB. 30 mL Saline. Ultrasound-guided application.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anaesthesiology, Glostrup University Hospital; 🇩🇰 Copenhagen, Glostrup, Denmark