Quadratus Lumborum Block for Abdominoplasty

Phase 4

Completed

• Conditions: Pain, Postoperative; Abdominoplasty
• Interventions: Procedure: QL-block; Drug: Ropivacaine; Drug: Sodium Chloride

• Registration Number: NCT02949778
• Lead Sponsor: Vestre Viken Hospital Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-27
• Study First Posted: 2016-10-31
• Study Start: 2016-11-07
• Primary Completion: 2017-06-15
• Status Verified: 2017-12
• Study Completion: 2017-12-13
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine 3.75mg/mL	QL-block	QL-block using 20 mL ropivacaine 3.75mg/mL
Ropivacaine 3.75mg/mL	Ropivacaine	QL-block using 20 mL ropivacaine 3.75mg/mL
Sodium chloride 9 mg/mL	QL-block	QL-block using 20 mL sterile sodium chloride 9 mg/mL
Sodium chloride 9 mg/mL	Sodium Chloride	QL-block using 20 mL sterile sodium chloride 9 mg/mL

Primary Outcome Measures

Name	Time	Method
Opioid consumption	24 hours	total opioid consumption the first 24 postoperative hours

Trial Locations

Locations (1)

Vestre Viken HT, Baerum Hospital; 🇳🇴 Sandvika, Norway