NCT01212666CompletedPhase 4
The Effect of Adductor-Canal-Block (ACB) in Patients After Anterior Cruciate Ligament (ACL) Reconstruction in Day Case Surgery
Glostrup University Hospital, Copenhagen2 sites in 1 country50 target enrollmentStarted: May 1, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Pain-score (VAS), patient standing
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Malene Espelund
MD
Glostrup University Hospital, Copenhagen
Study Sites (2)
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