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Clinical Trials/NCT01212666
NCT01212666
Completed
Phase 4

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

Glostrup University Hospital, Copenhagen1 site in 1 country50 target enrollmentMay 2010

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Reconstruction
Sponsor
Glostrup University Hospital, Copenhagen
Enrollment
50
Locations
1
Primary Endpoint
Pain-score (VAS), patient standing
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
March 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Glostrup University Hospital, Copenhagen
Responsible Party
Principal Investigator
Principal Investigator

Malene Espelund

MD

Glostrup University Hospital, Copenhagen

Eligibility Criteria

Inclusion Criteria

  • 18-70 years
  • Reconstruction of Anterior Cruciate Ligament
  • Written consent
  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Total Opioid-consumption(0-24 hours postoperative)
  • Postoperative Nausea and Vomiting(0 hours postoperative)
  • Postoperative ondansetron consumption(In hospital)
  • Pain-score (VAS), patient at rest(24 hours postoperative)
  • Pain-score (VAS), patient standing(24 hours postoperative)
  • Pain-score (VAS), after 5 meters of walk(24 hours postoperative)
  • Sedation(24 hours postoperative)
  • Pain (VAS) at rest, 0-24 hours postoperative (AUC)(0-24 h postoperative)
  • Pain (VAS), patient standing, 1-24 hours postoperative (AUC)(1-24 hours postoperative)
  • Pain (VAS), pain after 5 meters of walk, 2-24 hours postoperative (AUC)(2-24 hours postoperative)

Study Sites (1)

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