Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771459
• Other study ID #: H-D-2007-0111
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2008
• Last updated: June 22, 2011
• Start date: October 2008
• Est. completion date: August 2009

Study information

• Verified date: October 2008
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Ropivacaine 0.5 %
Local infiltration analgesia
• Isotonic NaCl
Local infiltration analgesia

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Copenhagen	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain		0-48 h postoperatively	No
Secondary	Analgesia consumption		0-48 h postoperatively	No