NCT01305603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

2.2 years

First QC Date

February 28, 2011

Last Update Submit

April 10, 2013

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Distribution of local anesthetic evaluated by MR scanning

    30 minutes after administering the TAP blocks

Secondary Outcomes (1)

  • Spread of anesthetized frontal dermatomes

    30 minutes after administering the TAP blocks

Study Arms (2)

Dual TAP block

ACTIVE COMPARATOR

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: BupivacaineProcedure: Injection

Classical (or single) TAP block

ACTIVE COMPARATOR

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: BupivacaineProcedure: Injection

Interventions

BupivacaineDRUG

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.

Also known as: Local anesthetic
Classical (or single) TAP blockDual TAP block
InjectionPROCEDURE

Injection under ultrasound-guidance

Also known as: Nerve blocks
Classical (or single) TAP blockDual TAP block

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital, Copenhagen University Hospital

Copenhagen, Capital Region of Denmark, 2400, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 20175754BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineAnesthetics, LocalInjectionsNerve Block

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesDrug Administration RoutesDrug TherapyTherapeuticsAnesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jens B Neimann, MD, PhD, MBA

    Dept. of Anesthesia, Bispebjerg Hospital, Copenhagen University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
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

Study Record Dates

First Submitted

February 28, 2011

First Posted

March 1, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations

DK(1)