Bilateral Dual Transversus Abdominis Plane Block for Robotic Assisted Laparoscopic Surgery

NCT ID: NCT01760161

Last Updated: 2015-05-12

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

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-02-29

Brief Summary

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To evaluate the effects of bilateral dual transversus abdominis plane block on postoperative pain after robotic assited laparoskopic surgery and measure the plasma-level of ropivacain after the bilateral dual transversus abdominis plane block.

Detailed Description

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After randomisation patients for robotic assisted laparoscopic surgery will receive bilateral dual transversus abdominis plane block containing either ropivacain or isotonic potassium chloride.

The investigators will record pain-score, opioid-consumption and sensibility on the abdominal wall in the postoperative periode.

Also a blood sample will be taken at 15, 30, 60, 120 and 240 minutes after the block in order to measure the plasma-level of ropivacain after bilateral dual transversus abdominis plane block.

The investigators assume that there will be significant effect on postoperative pain and that the level of plasma-ropivacain will be acceptable.

Conditions

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Pain Treatment Robotic Assisted Laparoscopic Surgery Bilateral Dual Transversus Abdominis Plane Block

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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Ropivacain

Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block

Isotonic potassium chloride

Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.

Group Type PLACEBO_COMPARATOR

Isotonic potassium chloride

Intervention Type DRUG

Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.

Interventions

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Ropivacaine

Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block

Intervention Type DRUG

Isotonic potassium chloride

Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients scheduled for robotic assisted laparoscopis surgery
* acceptance to participate

Exclusion Criteria

* allergies to local analgetics
* daily use of strong opioids
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nils Bjerregaard

Consultant Anestetist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aalborg Hospital

Aalborg, Region Nord, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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20120042

Identifier Type: -

Identifier Source: org_study_id

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