Method Study: Bilateral TAP Block With 24 Hours Infusion

NCT ID: NCT01577940

Last Updated: 2012-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this method study in healthy volunteers is to determine the extent of sensory block following Transversus Abdominis Plane (TAP) block with 24 hours infusion of ropivacaine versus infusion of saline. Furthermore, to determined the analgesic effect of the TAP block and the influence on the lung function.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Infusion of local anesthetic

TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours.

Group Type EXPERIMENTAL

Infusion of ropivacaine

Intervention Type PROCEDURE

TAP block with ropivacaine 20 ml 0,5%. Catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours on one side of the abdomen.

Infusion of saline

TAP block with 20 ml of ropivacaine 0,5%, catheter with infusion of saline 5 ml/h 24 hours.

Group Type PLACEBO_COMPARATOR

Infusion of saline

Intervention Type PROCEDURE

TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.

Interventions

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Infusion of ropivacaine

TAP block with ropivacaine 20 ml 0,5%. Catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours on one side of the abdomen.

Intervention Type PROCEDURE

Infusion of saline

TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age between 18 and 30 years
* written consent
* ASA 1
* BMI between 18 and 25
* males

Exclusion Criteria

* unable to communicate in Danish
* relevant drug allergy
* alcohol or/and drug abuse
* daily intake of prescription pain medication the last 4 weeks
* pain medication in the last 48 hours
* previously operated abdominal
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Pernille Lykke Petersen

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pernille L Petersen, MD

Role: PRINCIPAL_INVESTIGATOR

HOC, anesthesiology, Rigshospitalet, Copenhagen

Locations

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HOC, anesthesiology, Rigshospitalet

Copenhagen, , Denmark

Site Status

HovedOrtoCentret, Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Petersen PL, Hilsted KL, Dahl JB, Mathiesen O. Bilateral transversus abdominis plane (TAP) block with 24 hours ropivacaine infusion via TAP catheters: A randomized trial in healthy volunteers. BMC Anesthesiol. 2013 Oct 10;13(1):30. doi: 10.1186/1471-2253-13-30.

Reference Type DERIVED
PMID: 24106815 (View on PubMed)

Other Identifiers

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2011-005118-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SM1-PLP-11

Identifier Type: -

Identifier Source: org_study_id

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