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

September 9, 2012 updated by: Malene Espelund, Glostrup University Hospital, Copenhagen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Glostrup
      • Copenhagen, Glostrup, Denmark, 2600
        • Department of Anaesthesiology, Glostrup University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain-score (VAS), patient standing
Time Frame: 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.
2 hours postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Principal Investigator: Malene Espelund, MD, Glostrup University Hospital, Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

May 26, 2010

First Submitted That Met QC Criteria

September 30, 2010

First Posted (Estimate)

October 1, 2010

Study Record Updates

Last Update Posted (Estimate)

September 11, 2012

Last Update Submitted That Met QC Criteria

September 9, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM1-ME-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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