Quadratus Lumborum Block for Abdominoplasty

December 18, 2017 updated by: Vestre Viken Hospital Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Sandvika, Norway
        • Vestre Viken HT, Baerum Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ropivacaine 3.75mg/mL
QL-block using 20 mL ropivacaine 3.75mg/mL
Procedure: QL-block
Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied
Other Names:
  • Quadratus lumborum block
Drug: Ropivacaine
Ropivacaine 3.75mg/ml administered in QL-block as active treatment
Other Names:
  • Naropin
Placebo Comparator: Sodium chloride 9 mg/mL
QL-block using 20 mL sterile sodium chloride 9 mg/mL
Procedure: QL-block
Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied
Other Names:
  • Quadratus lumborum block
Drug: Sodium Chloride
Sodium chloride 9mg/mL administered in QL-Block as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: 24 hours
total opioid consumption the first 24 postoperative hours
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vestre Viken Hospital Trust

Investigators

  • Principal Investigator: Thor Wilhelm Bjelland, MD, PhD, Vestre Viken HT, Baerum Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2016

Primary Completion (Actual)

June 15, 2017

Study Completion (Actual)

December 13, 2017

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 31, 2016

Study Record Updates

Last Update Posted (Actual)

December 19, 2017

Last Update Submitted That Met QC Criteria

December 18, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BS-AIO-2015-QL-block

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Requires approval by ethics committee and second consent form.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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