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Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine 0.5 %
Isotonic NaCl
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Local infiltration analgesia, postoperative pain, ropivacaine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ropivacaine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Postoperative Pain

Secondary Outcome Measures

Analgesia consumption

Full Information

First Posted
October 10, 2008
Last Updated
June 22, 2011
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00771459
Brief Title
Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo
Official Title
Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo Ved Rygkirurgi for Spinalstenose: et Prospektivt Randomiseret, Dobbeltblindet, Placebo-kontrolleret Studie
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Local infiltration analgesia, postoperative pain, ropivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0.5 %
Intervention Description
Local infiltration analgesia
Intervention Type
Drug
Intervention Name(s)
Isotonic NaCl
Intervention Description
Local infiltration analgesia
Primary Outcome Measure Information:
Title
Postoperative Pain
Time Frame
0-48 h postoperatively
Secondary Outcome Measure Information:
Title
Analgesia consumption
Time Frame
0-48 h postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hvidovre University Hospital
City
Copenhagen
State/Province
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo

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