- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01105442
Local Anaesthesia Used During Fast-track Colonic Surgery: Evaluation of Bupivacaine and Levobupivacaine in Practice
July 20, 2011 updated by: Martini Hospital Groningen
The standard treatment for post operative pain is now bupivacaine + sufentanil.
The use of this combination during fast-track colonic surgery leads frequently to post-operative nausea and vomiting and limited mobilisation possibilities.
Therefore the department anaesthesiology wants to evaluate the use of a different local anaesthetic: levobupivacaine combined with morphine on demand.
The expectation is that the use of levobupivacaine leads to less side effects.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Groningen, Netherlands, 9700 RM
- Martini Hospital ward 4b
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Martini Hospital Groningen
Description
Inclusion Criteria:
- Patients who undergo fast-track colonic surgery and with post operative epidural pain treatment
Exclusion Criteria:
- Patients who are admitted to an other ward
- Patients with a spinal catheter
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Bupivacaine
Patients who received bupivacaine + sufentanil
|
Levobupivacaine
Patients who received levobupivacaine and morphine on demand
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Marinus van Hulst, Dr., Martini Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
April 15, 2010
First Submitted That Met QC Criteria
April 15, 2010
First Posted (Estimate)
April 16, 2010
Study Record Updates
Last Update Posted (Estimate)
July 21, 2011
Last Update Submitted That Met QC Criteria
July 20, 2011
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC2010-18
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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