Abdominoplasty, Pain, Postoperative
Conditions
Brief summary
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.
Interventions
Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied
Ropivacaine 3.75mg/ml administered in QL-block as active treatment
Sodium chloride 9mg/mL administered in QL-Block as placebo
Sponsors
Study design
Eligibility
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption | 24 hours | total opioid consumption the first 24 postoperative hours |
Countries
Norway