Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo

Phase 4

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Ropivacaine 0.5 %; Drug: Isotonic NaCl

• Registration Number: NCT00771459
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-10
• Study Start: 2008-10
• Study First Submitted: 2008-10-10
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Ropivacaine 0.5 %	-
Placebo	Isotonic NaCl	-

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	0-48 h postoperatively

Secondary Outcome Measures

Name	Time	Method
Analgesia consumption	0-48 h postoperatively

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Copenhagen, Hvidovre, Denmark