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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01040234
Other study ID # BBH_Z-Regional-001
Secondary ID
Status Completed
Phase Phase 4
First received December 17, 2009
Last updated October 21, 2015
Start date November 2009
Est. completion date January 2010

Study information

Verified date October 2015
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Department of Health
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Bilateral dual TAP block
Bupivacaine 2.5 mg/ml 15 ml per injection. 4 injections per patient according to dual TAP block procedure

Locations

Country Name City State
Denmark Dept Z, Bispebjerg Hospital Copenhagen Copenhagen NV

Sponsors (1)

Lead Sponsor Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain VAS after the intervention compared to pre-intervention VAS 10-20 minutes after intervention No
Secondary Pain medication required following intervention First 24 hours No
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