Skip to main content
OpenTrials
Completed

NCT Number: NCT02949778

Quadratus Lumborum Block for Abdominoplasty

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain, Postoperative Abdominoplasty Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vestre Viken HT, Baerum Hospital

Sandvika, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

QL-block

Procedure

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

Other names: Quadratus lumborum block

Ropivacaine

Drug

Ropivacaine 3.75mg/ml administered in QL-block as active treatment

Other names: Naropin

Sodium Chloride

Drug

Sodium chloride 9mg/mL administered in QL-Block as placebo

Primary outcomes

  1. Opioid consumption

    Time frame: 24 hours

    total opioid consumption the first 24 postoperative hours

Sponsors and collaborators

Lead sponsor

Vestre Viken Hospital Trust

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2016
Registry last updated
Dec 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.