Local Infiltration Analgesia in Major Spine Surgery With Ropivacaine Versus Placebo
Lokal Infiltrations Analgesi Med Ropivakain 0,5 % Versus Placebo Ved Rygkirurgi for Spinalstenose: et Prospektivt Randomiseret, Dobbeltblindet, Placebo-kontrolleret Studie
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 10, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedJune 23, 2011
October 1, 2008
10 months
October 10, 2008
June 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Pain
0-48 h postoperatively
Secondary Outcomes (1)
Analgesia consumption
0-48 h postoperatively
Study Arms (2)
Ropivacaine
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- patients eligible for major spine surgery
- must speak and understand Danish
- must be able to give oral and written consent
You may not qualify if:
- alcohol or medicine abuse
- treatment with opioids \> 100 mg daily
- allergy to local anesthetics
- severe obesity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hvidovre University Hospital
Copenhagen, Hvidovre, 2650, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 10, 2008
First Posted
October 13, 2008
Study Start
October 1, 2008
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
June 23, 2011
Record last verified: 2008-10