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Clinical Trials/NCT01261897
NCT01261897CompletedPhase 4

The Efficacy of Adductor-Canal-Blockade on Pain and Morphine Consumption After Total Knee Arthroplasty

Rigshospitalet, Denmark1 site in 1 country40 target enrollmentStarted: January 1, 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Pain during 45 degrees active flexion of the knee
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The objective of this study is to assess the efficacy of Adductor-Canal-Blockade on pain and morphine consumption after total knee arthroplasty. Our hypothesis is that the Adductor -Canal-Blockade is superior to placebo in reducing pain and morphine consumption after total knee arthroplasty.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Total Knee Arthroplasty in general anaesthesia
  • •BMI 18-40
  • •Written informed consent

Exclusion Criteria

  • •Can not cooperate to the exam
  • •Do not speak or understand Danish
  • •Drug allergy
  • •Alcohol or drug abuse
  • •Daily consumption of strong opioids

Arms & Interventions

Adductor-Canal-Blockade with Ropivacaine

Active Comparator

Intervention: Adductor-Canal-Blockade with Ropivacaine (Procedure)

Adductor-Canal-blockade with saline

Placebo Comparator

Intervention: Adductor-Canal-blockade with saline (Procedure)

Outcomes

Primary Outcomes

Pain during 45 degrees active flexion of the knee

Time Frame: 1 hour postoperative

0-100 mm at a visual analogue scale (VAS), at 1 hour postoperative

Secondary Outcomes

  • Pain during 45 degrees active flexion of the knee(0-6 hours postoperative)
  • Pain during rest(1-6 hours postoperative)
  • A change in pain score in the ropivacaine group, after activating the block(30-60 minutes postoperative)
  • Total morphine consumption(30 minutes - 6 hours postoperative)
  • Postoperative nausea(1-6 hours postoperative)
  • Postoperative vomiting(1-6 hours postoperative)
  • Zofran consumption(1-6 hours postoperative)
  • Sedation(1-6 hours postoperative)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pia Jaeger

MD

Rigshospitalet, Denmark

Study Sites (1)

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