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Quadratus Lumborum Block for Abdominoplasty

NCT ID: NCT02949778

Last Updated: 2017-12-19

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-07

Study Completion Date

2017-12-13

Brief Summary

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Double blinded, randomized, controlled, phase IV intervention trial. Both groups will receive a quadratus lumborum Block (QL), using ropivacaine 3.75 mg/mL in the intervention group, and sterile sodium chloride in the control group. The aim of study is to investigate the effect of a QL Block on the perioperative pain during postbariatric abdominoplasty.

Detailed Description

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Conditions

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Pain, Postoperative Abdominoplasty

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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Ropivacaine 3.75mg/mL

QL-block using 20 mL ropivacaine 3.75mg/mL

Group Type ACTIVE_COMPARATOR

QL-block

Intervention Type PROCEDURE

Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied

Ropivacaine

Intervention Type DRUG

Ropivacaine 3.75mg/ml administered in QL-block as active treatment

Sodium chloride 9 mg/mL

QL-block using 20 mL sterile sodium chloride 9 mg/mL

Group Type PLACEBO_COMPARATOR

QL-block

Intervention Type PROCEDURE

Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied

Sodium Chloride

Intervention Type DRUG

Sodium chloride 9mg/mL administered in QL-Block as placebo

Interventions

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QL-block

Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied

Intervention Type PROCEDURE

Ropivacaine

Ropivacaine 3.75mg/ml administered in QL-block as active treatment

Intervention Type DRUG

Sodium Chloride

Sodium chloride 9mg/mL administered in QL-Block as placebo

Intervention Type DRUG

Other Intervention Names

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Quadratus lumborum block Naropin

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists Physical Classification Status (ASA) I-II
* Age 18 to 64
* Weight above or equal to 60 kg
* Scheduled for post-bariatric surgery with standard full abdominoplasty performed by Dr Frøyen
* Patient is expected able to cooperate during the treatment and follow up.
* Signed informed consent obtained and documented according to the International Conference on Harmonization (ICH) good clinical practice (GCP), and national/local regulations.

Exclusion Criteria

* A history of anaphylactic shock
* Cardiovascular disease other than hypertension and/or hyperlipidemia
* Known allergy to ropivacaine or morphine
* A history of chronic pain
* Psychiatric comorbidity
* Scheduled opioid pain medication or neuroleptic drugs
* Coagulation disorders or treatment with platelet inhibitors
* Pregnancy or breastfeeding
* Treatment with class III antiarrhythmics, sertindole, ziprasidone, amisulpride, ceritinib, hydroxyzine, fluvoxamine
* Any medical contraindication to the study intervention by the attending anaesthetist or surgeon (to be specified in screening form).
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vestre Viken Hospital Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thor Wilhelm Bjelland, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vestre Viken HT, Baerum Hospital

Locations

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Vestre Viken HT, Baerum Hospital

Sandvika, , Norway

Site Status

Countries

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Norway

Other Identifiers

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BS-AIO-2015-QL-block

Identifier Type: -

Identifier Source: org_study_id