Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00771459
First received: October 10, 2008
Last updated: June 22, 2011
Last verified: October 2008
  Purpose

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 Intervention Phase
Pain, Postoperative
Drug: Ropivacaine 0.5 %
Drug: Isotonic NaCl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Postoperative Pain [ Time Frame: 0-48 h postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analgesia consumption [ Time Frame: 0-48 h postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: October 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ropivacaine Drug: Ropivacaine 0.5 %
Local infiltration analgesia
Placebo Comparator: Placebo Drug: Isotonic NaCl
Local infiltration analgesia

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771459

Locations
Denmark
Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
  More Information

No publications provided

Responsible Party: Billy B Kristensen, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00771459     History of Changes
Other Study ID Numbers: H-D-2007-0111
Study First Received: October 10, 2008
Last Updated: June 22, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Local infiltration analgesia
postoperative pain
ropivacaine

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014