Ultrasound-guided Dual TAP Block: Magnetic Resonance (MR) Evaluation of the Distribution of Local Anesthetic

April 10, 2013 updated by: Jens Borglum Neimann, Bispebjerg Hospital

Dual TAP Block Characteristics - Evaluation of Local Anesthetic Distribution by MR Scanning

Using Magnetic resonance (MR) scanning and ultrasonography the investigators wish to investigate, in what way a known volume of local anesthetic injectate will be distributed in the transverse abdominis plane (TAP) in young healthy male volunteers. The investigators compare the anatomical distribution of the local anesthetic injectate in the TAP when performing an ultrasound-guided classical TAP block and a Dual TAP block. The investigators also want to compare the spread of anesthetized frontal dermatomes when performing an ultrasound-guided classical TAP block and a Dual TAP block.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There has been much debate as to what extent the classical TAP block will anesthetize more than the frontal dermatomes (TH10-Th12/L1). Some cadaver studies have been performed with injection of dye in the classical TAP. However, it is still not clear whether a single injection of local anesthetic in the classical TAP block position will reach the more cephalad and medial intercostal TAP plexus (Th6-Th9). In this study the investigators use MR scanning and ultrasonography to investigate in what way a known volume of local anesthetic injectate will be distributed in the transverse abdominis plane (TAP) in young healthy male volunteers. The investigators compare the anatomical distribution of the local anesthetic injectate in the TAP when performing an ultrasound-guided classical TAP block and a Dual TAP block. The investigators also want to compare the spread of anesthetized frontal dermatomes when performing an ultrasound-guided classical TAP block and a Dual TAP block.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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

  • Denmark
    • Capital Region of Denmark
      • Copenhagen, Capital Region of Denmark, Denmark, 2400
        • Bispebjerg Hospital, Copenhagen University 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy male
  • 18 years old or more
  • had no previous abdominal surgery
  • no regular medication
  • no coagulation disorders
  • no claustrophobia

Exclusion Criteria:

  • if the volunteer is not able to accept an uncomplicated administration of a classical (single) or dual TAP block

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Dual TAP block
Dual TAP block on one side on the abdomen. Classical (or single) TAP on the contra lateral side of the abdomen; supplemented with a sham injection to ensure double blindness.
Drug: Bupivacaine
On both sides of the abdomen 30 ml of bupivacaine 2.5 mg/ml will be injected. This is a total of 60 ml of bupivacaine 2.5 mg/ml.
Other Names:
  • Local anesthetic
Procedure: Injection
Injection under ultrasound-guidance
Other Names:
  • Nerve blocks
ACTIVE_COMPARATOR: Classical (or single) TAP block
Dual TAP block on one side on the abdomen. Classical (or single) TAP on the contra lateral side of the abdomen; supplemented with a sham injection to ensure double blindness
Drug: Bupivacaine
On both sides of the abdomen 30 ml of bupivacaine 2.5 mg/ml will be injected. This is a total of 60 ml of bupivacaine 2.5 mg/ml.
Other Names:
  • Local anesthetic
Procedure: Injection
Injection under ultrasound-guidance
Other Names:
  • Nerve blocks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distribution of local anesthetic evaluated by MR scanning
Time Frame: 30 minutes after administering the TAP blocks
30 minutes after administering the TAP blocks

Secondary Outcome Measures

Outcome Measure
Time Frame
Spread of anesthetized frontal dermatomes
Time Frame: 30 minutes after administering the TAP blocks
30 minutes after administering the TAP blocks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Jens B Neimann, MD, PhD, MBA, Dept. of Anesthesia, Bispebjerg Hospital, Copenhagen University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

April 1, 2013

Study Registration Dates

First Submitted

February 28, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (ESTIMATE)

March 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBH-USG-PNB-1

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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