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

Sponsor
Bispebjerg Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01305603
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
26
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dual TAP Block Characteristics - Evaluation of Local Anesthetic Distribution by MR Scanning
Study Start Date :
Feb 1, 2011
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Distribution of local anesthetic evaluated by MR scanning [30 minutes after administering the TAP blocks]

    Secondary Outcome Measures

    1. Spread of anesthetized frontal dermatomes [30 minutes after administering the TAP blocks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bispebjerg Hospital, Copenhagen University Hospital Copenhagen Capital Region of Denmark Denmark 2400

    Sponsors and Collaborators

    • Bispebjerg Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jens Borglum Neimann, Jens Børglum Neimann, MD, PhD, MBA, Consultant Anesthetist, Bispebjerg Hospital, Copenhagen University Hospital, Department of Anesthesia and Intensive Care Medicine, Bispebjerg Bakke 23, DK-2400 Copenhagen NV, Denmark, Bispebjerg Hospital
    ClinicalTrials.gov Identifier:
    NCT01305603
    Other Study ID Numbers:
    • BBH-USG-PNB-1
    First Posted:
    Mar 1, 2011
    Last Update Posted:
    Apr 11, 2013
    Last Verified:
    Apr 1, 2013
    Additional relevant MeSH terms:
    Pain, Postoperative
    Bupivacaine
    Anesthetics, Local
    Anesthetics

    Study Results

    No Results Posted as of Apr 11, 2013