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Transversus Abdominis Plane Block After Robot-assisted Laparocopic Hysterectomy

NCT ID: NCT01504386

Last Updated: 2013-08-22

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after robot-assisted laparoscopic hysterecomy.

Detailed Description

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Conditions

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Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TAP block

TAP block with ropivacaine

Group Type EXPERIMENTAL

TAP block

Intervention Type PROCEDURE

Bilateral UL-guided TAP block with 20 ml of ropivacaine 0.5 %

Placebo TAP block

Sham block with saline

Group Type PLACEBO_COMPARATOR

Placebo TAP block

Intervention Type PROCEDURE

Bilateral placement of 20 ml of saline 0.9 % in the transversus abdominis plane

Interventions

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TAP block

Bilateral UL-guided TAP block with 20 ml of ropivacaine 0.5 %

Intervention Type PROCEDURE

Placebo TAP block

Bilateral placement of 20 ml of saline 0.9 % in the transversus abdominis plane

Intervention Type PROCEDURE

Other Intervention Names

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Naropin 0.5% Saline 0.9%

Eligibility Criteria

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Inclusion Criteria

* Age 18-80
* BMI 17-40
* Written consent
* Can cooperate

Exclusion Criteria

* Drug and alcohol abuse
* Consumption of opioids
* Drug allergy
* Infection at insertion point of needle
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Copenhagen University Hospital at Herlev

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Henrik Torup, MD

Role: PRINCIPAL_INVESTIGATOR

Herlev University Hospital, Copenhagen

Locations

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Herlev Univerity Hospital, Department of Anaesthesia

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SM1-HT-2011

Identifier Type: -

Identifier Source: org_study_id