Quadratus Lumborum Block for Abdominoplasty

Vestre Viken Hospital Trust

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative; Abdominoplasty

Treatments: Drug: Ropivacaine; Drug: Sodium Chloride; Procedure: QL-block

Study type: Interventional

Funder types: Other

Identifiers

NCT02949778

BS-AIO-2015-QL-block

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Ropivacaine 3.75mg/mL

Active Comparator group

Description:

QL-block using 20 mL ropivacaine 3.75mg/mL

Treatment:

Procedure: QL-block

Drug: Ropivacaine

Sodium chloride 9 mg/mL

Placebo Comparator group

Description:

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

Treatment:

Drug: Sodium Chloride

Procedure: QL-block