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Bilateral Dual TAP Block: Description of a Novel Four-point Approach

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Bispebjerg Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01040234
First received: December 17, 2009
Last updated: December 28, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Procedure: Bilateral dual TAP block
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound-guided Bilateral Dual Transversus Abdominis Plane (BD-TAP) Block: Description of a Novel Four-point Ultrasound-guided TAP Block Approach

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Pain VAS after the intervention compared to pre-intervention VAS [ Time Frame: 10-20 minutes after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain medication required following intervention [ Time Frame: First 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Active pain treatment
Bilateral dual TAP block
Procedure: 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:
  • Marcain
  • TAP block

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040234

Contacts
Contact: Jens N Børglum, MD, PhD +4535313531 ext 4374 jbn@dadlnet.dk
Contact: Kenneth Jensen, MD +4535313531 ext 4496 kenneth.jensen@bbh.regionh.dk

Locations
Denmark
Dept Z, Bispebjerg Hospital Recruiting
Copenhagen, Copenhagen NV, Denmark, 2400
Contact: Jens N Børglum, MD, PhD    +4535313531 ext 4374    jbn@dadlnet.dk   
Contact: Kenneth Jensen, MD    +4535313531 ext 4496    kenneth.jensen@bbh.regionh.dk   
Principal Investigator: Jens N Børglum, MD, PhD         
Sub-Investigator: Kenneth Jensen, MD         
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Principal Investigator: Jens N Børglum, MD, PhD Dept Z, Bispebjerg Hospital
  More Information

No publications provided

Responsible Party: Jens Børglum, MD, PhD, assistant professor, Dept of Anaesthesia and Intensive Care, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01040234     History of Changes
Other Study ID Numbers: BBH_Z-Regional-001
Study First Received: December 17, 2009
Last Updated: December 28, 2009
Health Authority: Denmark: Department of Health

Keywords provided by Bispebjerg Hospital:
postoperative pain
abdominal surgery
bilateral dual TAP block

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014