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Clinical Trials/NCT00771459
NCT00771459
Completed
Phase 4

Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo Ved Rygkirurgi for Spinalstenose: et Prospektivt Randomiseret, Dobbeltblindet, Placebo-kontrolleret Studie

Hvidovre University Hospital1 site in 1 country48 target enrollmentOctober 2008
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ConditionsPain, Postoperative
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 examine whether local infiltration analgesia (LIA) with Ropivacaine and adrenaline is effective in the treatment of postoperative pain after major spine surgery.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
August 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •patients eligible for major spine surgery
  • •must speak and understand Danish
  • •must be able to give oral and written consent

Exclusion Criteria

  • •alcohol or medicine abuse
  • •treatment with opioids \> 100 mg daily
  • •allergy to local anesthetics
  • •severe obesity

Arms & Interventions

Ropivacaine

Intervention: Ropivacaine 0.5 %

Placebo

Intervention: Isotonic NaCl

Outcomes

Primary Outcomes

Postoperative Pain

Time Frame: 0-48 h postoperatively

Secondary Outcomes

  • Analgesia consumption(0-48 h postoperatively)

Study Sites (1)

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