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Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00771459
Recruitment Status : Completed
First Posted : October 13, 2008
Last Update Posted : June 23, 2011
Information provided by:
Hvidovre University Hospital

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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Ropivacaine 0.5 % Drug: Isotonic NaCl Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo Ved Rygkirurgi for Spinalstenose: et Prospektivt Randomiseret, Dobbeltblindet, Placebo-kontrolleret Studie
Study Start Date : October 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Ropivacaine Drug: Ropivacaine 0.5 %
Local infiltration analgesia

Placebo Comparator: Placebo Drug: Isotonic NaCl
Local infiltration analgesia

Primary Outcome Measures :
  1. Postoperative Pain [ Time Frame: 0-48 h postoperatively ]

Secondary Outcome Measures :
  1. Analgesia consumption [ Time Frame: 0-48 h postoperatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00771459

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Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
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Responsible Party: Billy B Kristensen, Hvidovre University Hospital Identifier: NCT00771459    
Other Study ID Numbers: H-D-2007-0111
First Posted: October 13, 2008    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: October 2008
Keywords provided by Hvidovre University Hospital:
Local infiltration analgesia
postoperative pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents