Quadratus Lumborum Block for Abdominoplasty

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02949778
• Other study ID #: BS-AIO-2015-QL-block
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2016
• Last updated: December 18, 2017
• Start date: November 7, 2016
• Est. completion date: December 13, 2017

Study information

• Verified date: December 2017
• Source: Vestre Viken Hospital Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 13, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

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).

Related Conditions & MeSH terms

• Abdominoplasty
• Pain, Postoperative

Intervention

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

Drug:
• Ropivacaine
Ropivacaine 3.75mg/ml administered in QL-block as active treatment
• Sodium Chloride
Sodium chloride 9mg/mL administered in QL-Block as placebo

Locations

Country	Name	City	State
Norway	Vestre Viken HT, Baerum Hospital	Sandvika

Sponsors (1)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	total opioid consumption the first 24 postoperative hours	24 hours