Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy

NCT ID: NCT02225418

Last Updated: 2015-07-22

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Brief Summary

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The TQL block may prove a valuable method for treating postoperative pain following scopic removal of the gall bladder.

The trial will compare active TQL block versus placebo TQL block after said operation.

The hypothesis is that active TQL block significantly will reduce postoperative pain following scopic removal of the gall bladder compared with placebo TQL block.

Detailed Description

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Conditions

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Cholecystitis Pain

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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Placebo TQL block

30 ml single shot TQL block with saline 0,9%

Group Type SHAM_COMPARATOR

saline

Intervention Type DRUG

Active TQL block

30 ml single shot TQL block with ropivacaine 0,75%

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Interventions

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Ropivacaine

Intervention Type DRUG

saline

Intervention Type DRUG

Other Intervention Names

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naropin

Eligibility Criteria

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Inclusion Criteria

* scheduled for elective laparoscopic cholecystectomy
* received oral and written information about the trial
* American Society of Anaethesiologists (ASA) classification 1-3
* NRS score \> 3 upon arrival at the PACU area

Exclusion Criteria

* Cannot cooperate
* Does not speak or understand Danish
* Allergy towards drugs used in the trial
* Large daily consumption of opioids
* Known alcohol og medicin abuse
* Difficult or impossible by ultrasound to visualise the intended nerve/tissue structures necessary to perform block
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Jens Borglum Neimann

OTHER

Sponsor Role lead

Responsible Party

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Jens Borglum Neimann

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jens Børglum, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital Bispebjerg

Locations

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Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2013-001364-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BBH-TQL-LC

Identifier Type: -

Identifier Source: org_study_id

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