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

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212666
• Other study ID #: SM1-ME-10
• Status: Completed
• Phase: Phase 4
• First received: May 26, 2010
• Last updated: September 9, 2012
• Start date: May 2010
• Est. completion date: March 2012

Study information

• Verified date: September 2012
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Procedure:
• Ropivacain
Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.
• Saline
Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.

Locations

Country	Name	City	State
Denmark	Department of Anaesthesiology, Glostrup University Hospital	Copenhagen	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Total Opioid-consumption	ACB-group vs. placebo-group	0-24 hours postoperative	No
Secondary	Postoperative Nausea and Vomiting	Levels of nausea (0-3). ACB-group vs. placebo-group	0 hour postoperative	No
Secondary	Postoperative ondansetron consumption		In hospital	No
Secondary	Pain-score (VAS), patient at rest	ACB-group vs. placebo	0 hours postoperative	No
Secondary	Pain-score (VAS), patient at rest	ACB-group vs. placebo	1 hour postoperative	No
Secondary	Pain-score (VAS), patient at rest	ACB-group vs. placebo	2 hours postoperative	No
Secondary	Pain-score (VAS), patient at rest	ACB-group vs. placebo	4 hours postoperative	No
Secondary	Pain-score (VAS), patient at rest	ACB-group vs. placebo	6 hours postoperative	No
Secondary	Pain-score (VAS), patient at rest	ACB-group vs. placebo	8 hours postoperative	No
Secondary	Pain-score (VAS), patient at rest	ACB-group vs. placebo	24 hours postoperative	No
Secondary	Pain-score (VAS), patient standing	ACB-group vs. placebo	1 hour postoperative	No
Secondary	Pain-score (VAS), patient standing	ACB-group vs. placebo	2 hours postoperative	No
Secondary	Pain-score (VAS), patient standing	ACB-group vs. placebo	4 hours postoperative	No
Secondary	Pain-score (VAS), patient standing	ACB-group vs. placebo	6 hours postoperative	No
Secondary	Pain-score (VAS), patient standing	ACB-group vs. placebo	8 hours postoperative	No
Secondary	Pain-score (VAS), patient standing	ACB-group vs. placebo	24 hours postoperative	No
Secondary	Pain-score (VAS), after 5 meters of walk	ACB-group vs. placebo	2 hours postoperative	No
Secondary	Pain-score (VAS), after 5 meters of walk	ACB-group vs. placebo	4 hours postoperative	No
Secondary	Pain-score (VAS), after 5 meters of walk	ACB-group vs. placebo	6 hours postoperative	No
Secondary	Pain-score (VAS), after 5 meters of walk	ACB-group vs. placebo	8 hours postoperative	No
Secondary	Pain-score (VAS), after 5 meters of walk	ACB-group vs. placebo	24 hours postoperative	No
Secondary	Postoperative Nausea and Vomiting	Levels of nausea (0-3). ACB-group vs. placebo-group	1 hours postoperative	No
Secondary	Postoperative Nausea and Vomiting	Levels of nausea (0-3). ACB-group vs. placebo-group	2 hours postoperative	No
Secondary	Postoperative Nausea and Vomiting	Levels of nausea (0-3). ACB-group vs. placebo-group	4 hours postoperative	No
Secondary	Postoperative Nausea and Vomiting	Levels of nausea (0-3). ACB-group vs. placebo-group	6 hours postoperative	No
Secondary	Postoperative Nausea and Vomiting	Levels of nausea (0-3). ACB-group vs. placebo-group	8 hours postoperative	No
Secondary	Postoperative Nausea and Vomiting	Levels of nausea (0-3). ACB-group vs. placebo-group	24 hours postoperative	No
Secondary	Sedation	Levels of sedation (0-3). ACB-group vs. placebo	0, hour postoperative	No
Secondary	Sedation	Levels of sedation (0-3). ACB-group vs. placebo	1 hour postoperative	No
Secondary	Sedation	Levels of sedation (0-3). ACB-group vs. placebo	2 hours postoperative	No
Secondary	Sedation	Levels of sedation (0-3). ACB-group vs. placebo	4 hours postoperative	No
Secondary	Sedation	Levels of sedation (0-3). ACB-group vs. placebo	6 hours postoperative	No
Secondary	Sedation	Levels of sedation (0-3). ACB-group vs. placebo	8 hours postoperative	No
Secondary	Sedation	Levels of sedation (0-3). ACB-group vs. placebo	24 hours postoperative	No
Secondary	Postoperative Nausea and Vomiting	Levels of nausea (0-3). ACB-group vs. placebo-group	0 hours postoperative	No
Secondary	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	No
Secondary	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	No
Secondary	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	No