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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jens Borglum Neimann, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01305603
First received: February 28, 2011
Last updated: April 10, 2013
Last verified: April 2013
  Purpose

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 Intervention
Pain, Postoperative
Drug: Bupivacaine
Procedure: Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dual TAP Block Characteristics - Evaluation of Local Anesthetic Distribution by MR Scanning

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Distribution of local anesthetic evaluated by MR scanning [ Time Frame: 30 minutes after administering the TAP blocks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spread of anesthetized frontal dermatomes [ Time Frame: 30 minutes after administering the TAP blocks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Local anesthetic
Procedure: Injection
Injection under ultrasound-guidance
Other Name: 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 Name: Local anesthetic
Procedure: Injection
Injection under ultrasound-guidance
Other Name: Nerve blocks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01305603

Locations
Denmark
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
  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     History of Changes
Other Study ID Numbers: BBH-USG-PNB-1
Study First Received: February 28, 2011
Last Updated: April 10, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Anesthetics, Local
Bupivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014