Ultrasound-guided Dual TAP Block: Magnetic Resonance (MR) Evaluation of the Distribution of Local Anesthetic
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Bupivacaine
Injection
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility 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
Sites / Locations
- Bispebjerg Hospital, Copenhagen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dual TAP block
Classical (or single) TAP block
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Distribution of local anesthetic evaluated by MR scanning
Secondary Outcome Measures
Spread of anesthetized frontal dermatomes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01305603
Brief Title
Ultrasound-guided Dual TAP Block: Magnetic Resonance (MR) Evaluation of the Distribution of Local Anesthetic
Official Title
Dual TAP Block Characteristics - Evaluation of Local Anesthetic Distribution by MR Scanning
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dual TAP block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Classical (or single) TAP block
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Local anesthetic
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Injection
Other Intervention Name(s)
Nerve blocks
Intervention Description
Injection under ultrasound-guidance
Primary Outcome Measure Information:
Title
Distribution of local anesthetic evaluated by MR scanning
Time Frame
30 minutes after administering the TAP blocks
Secondary Outcome Measure Information:
Title
Spread of anesthetized frontal dermatomes
Time Frame
30 minutes after administering the TAP blocks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens B Neimann, MD, PhD, MBA
Organizational Affiliation
Dept. of Anesthesia, Bispebjerg Hospital, Copenhagen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital, Copenhagen University Hospital
City
Copenhagen
State/Province
Capital Region of Denmark
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
20175754
Citation
Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
Results Reference
background
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Ultrasound-guided Dual TAP Block: Magnetic Resonance (MR) Evaluation of the Distribution of Local Anesthetic
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