Quadratus Lumborum Block for Abdominoplasty

Vestre Viken Hospital Trust50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain, Postoperative Abdominoplasty

Interventions

QL-blockPROCEDURE

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

RopivacaineDRUG

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

Sodium ChlorideDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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).

Locations (1)

Vestre Viken HT, Baerum Hospital

Sandvika, Norway

Outcomes

Primary Outcomes

Opioid consumption

total opioid consumption the first 24 postoperative hours

Time frame: 24 hours

Data from ClinicalTrials.gov

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