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Clinical Trials/NCT00768456
NCT00768456
Completed
Phase 4

Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo VED Vaginal Hysterektomi: ET Prospektivt Randomiseret, Dobbeltblind ET, Placebo-kontrolleret Studie

Hvidovre University Hospital1 site in 1 country48 target enrollmentOctober 2008
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ConditionsPain, PostoperativePostoperative Nausea and Vomiting
InterventionsRopivacaine 0.5 %Isotonic NaCl
DrugsRopivacaine 0.5 %Isotonic NaCl

Overview

Phase
Phase 4
Intervention
Ropivacaine 0.5 %
Conditions
Pain, Postoperative
Sponsor
Hvidovre University Hospital
Enrollment
48
Locations
1
Primary Endpoint
Postoperative pain
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to compare systematic local infiltration with Ropivacaine 0.5 % vs. Placebo in patients undergoing vaginal hysterectomy.

The hypothesis is that systematic local infiltration will reduce postoperative pain and postoperative opioid consumption.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
December 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •eligible for elective vaginal hysterectomy
  • •able to speak and understand Danish
  • •able to give informed consent

Exclusion Criteria

  • •alcohol or medical abuse
  • •allergies to local anesthetics
  • •age \< 18 yrs.
  • •intolerance to opioids

Arms & Interventions

1

Local infiltration with Ropivacaine

Intervention: Ropivacaine 0.5 %

2

Local infiltration with Placebo (NaCl)

Intervention: Isotonic NaCl

Outcomes

Primary Outcomes

Postoperative pain

Time Frame: 32 h

Secondary Outcomes

  • PONV(32 h)

Study Sites (1)

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