- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01040234
Bilateral Dual TAP Block: Description of a Novel Four-point Approach
October 21, 2015 updated by: Kenneth Jensen, MD, BBA, Bispebjerg Hospital
Ultrasound-guided Bilateral Dual Transversus Abdominis Plane (BD-TAP) Block: Description of a Novel Four-point Ultrasound-guided TAP Block Approach
A prospective study of 30 patients with severe postoperative pain following abdominal surgery, in which the dual TAP block technique has been used successfully to achieve pain relief.
A description of ultrasound technique, effectiveness, duration and potential side effects of the pain treatment, with possible recommendations for future use.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This prospective cohort study is designed to describe a novel ultrasound-guided bilateral dual transversus abdominis plane (BD-TAP) block and to evaluate the postoperative analgesic efficacy in a selection of patients having undergone major abdominal surgery under general anaesthesia where neuraxial anaesthesia and/or intravenous administration of analgesics had failed or was unwanted by the patient, or if the placement of an epidural catheter was deemed impossible by the anaesthetist in charge.
30 consecutive patients planned for the study.
BD-TAP to be performed bilaterally with a high frequency linear ultrasound probe, with bupivacaine.
Success rate, decline in VAS score, postoperative demand of opioids and block performance time to be recorded.
Study Type
Observational
Enrollment (Actual)
30
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
-
-
Copenhagen NV
-
Copenhagen, Copenhagen NV, Denmark, 2400
- Dept Z, Bispebjerg Hospital
-
-
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
15 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with postoperative pain following abdominal surgery that do not respond to moderate doses of opioid analgesics or patients with failed epidurals
Description
Inclusion Criteria:
- Patients with pain VAS >5 following abdominal surgery, in which conventional pain treatment or epidural block is either ineffective or contraindicated
Exclusion Criteria:
- Hypersensitivity to local anaesthetics
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 |
Intervention / Treatment |
---|---|
Active pain treatment
Bilateral dual TAP block
|
Bupivacaine 2.5 mg/ml 15 ml per injection.
4 injections per patient according to dual TAP block procedure
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain VAS after the intervention compared to pre-intervention VAS
Time Frame: 10-20 minutes after intervention
|
10-20 minutes after intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain medication required following intervention
Time Frame: First 24 hours
|
First 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jens N Børglum, MD, PhD, Dept Z, Bispebjerg 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
November 1, 2009
Primary Completion (ACTUAL)
January 1, 2010
Study Completion (ACTUAL)
January 1, 2010
Study Registration Dates
First Submitted
December 17, 2009
First Submitted That Met QC Criteria
December 28, 2009
First Posted (ESTIMATE)
December 29, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
October 23, 2015
Last Update Submitted That Met QC Criteria
October 21, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BBH_Z-Regional-001
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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