Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo

NCT ID: NCT00771459

Last Updated: 2011-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-08-31

Brief Summary

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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

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Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ropivacaine

Group Type ACTIVE_COMPARATOR

Ropivacaine 0.5 %

Intervention Type DRUG

Local infiltration analgesia

Placebo

Group Type PLACEBO_COMPARATOR

Isotonic NaCl

Intervention Type DRUG

Local infiltration analgesia

Interventions

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Ropivacaine 0.5 %

Local infiltration analgesia

Intervention Type DRUG

Isotonic NaCl

Local infiltration analgesia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-D-2007-0111

Identifier Type: -

Identifier Source: org_study_id

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