Quadratus Lumborum Block for Abdominoplasty

Study Overview
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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.

Official Title
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Quadratus Lumborum Block for Perioperative Analgesia in Patients Treated With Abdominoplasty: A Randomised Controlled Trial

Conditions
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Pain, Postoperative, Abdominoplasty

Intervention / Treatment
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* Procedure: QL-block
* Drug: Ropivacaine
* Drug: Sodium Chloride


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine 3.75mg/mL<br>QL-block using 20 mL ropivacaine 3.75mg/mL | Procedure: QL-block<br>* Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied<br>* Other names: Quadratus lumborum block;Drug: Ropivacaine<br>* Ropivacaine 3.75mg/ml administered in QL-block as active treatment<br>* Other names: Naropin;|
| Placebo Comparator: Sodium chloride 9 mg/mL<br>QL-block using 20 mL sterile sodium chloride 9 mg/mL | Procedure: QL-block<br>* Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied<br>* Other names: Quadratus lumborum block;Drug: Sodium Chloride<br>* Sodium chloride 9mg/mL administered in QL-Block as placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | total opioid consumption the first 24 postoperative hours | 24 hours |