Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo

This study is currently recruiting participants.

Verified by Hvidovre University Hospital, October 2008

Sponsored by:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00771459

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 IV

Drug Information available for: Ropivacaine Ropivacaine Hydrochloride Ropivacaine monohydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo Ved Rygkirurgi for Spinalstenose: et Prospektivt Randomiseret, Dobbeltblindet, Placebo-Kontrolleret Studie

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
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Ropivacaine: Active Comparator	Drug: Ropivacaine 0.5 % Local infiltration analgesia
Placebo: Placebo Comparator	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

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

Contacts

Contact: Billy B Kristensen, MD

+45 36 32 25 27

billy.kristensen@hvh.regionh.dk

Locations

Denmark, Hvidovre
Hvidovre University Hospital	Recruiting
Copenhagen, Hvidovre, Denmark, 2650
Contact: Billy B Kristensen, MD + 45 36 32 25 27 billy.kristensen@hvh.regionh.dk
Principal Investigator: Billy B Kristensen, MD

Sponsors and Collaborators

Hvidovre University Hospital

More Information

Responsible Party:	Hvidovre University Hospital ( Billy B Kristensen )
Study ID Numbers:	H-D-2007-0111
Study First Received:	October 10, 2008
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00771459
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

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Ropivacaine
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants

Anesthetics
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 16, 2009