Quadratus Lumborum Block for Abdominoplasty

NCT02949778 | Completed Phase 4 DMC

• 1 other identifier: BS-AIO-2015-QL-block
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Abdominoplasty

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  total opioid consumption the first 24 postoperative hours

  24 hours

Study Arms (2)

Ropivacaine 3.75mg/mL

ACTIVE COMPARATOR

QL-block using 20 mL ropivacaine 3.75mg/mL

Procedure: QL-block; Drug: Ropivacaine

Sodium chloride 9 mg/mL

PLACEBO COMPARATOR

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

Procedure: QL-block; Drug: Sodium Chloride

Interventions

QL-block PROCEDURE

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

Also known as: Quadratus lumborum block

Ropivacaine 3.75mg/mL; Sodium chloride 9 mg/mL

Ropivacaine DRUG

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

Also known as: Naropin

Ropivacaine 3.75mg/mL

Sodium Chloride DRUG

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

Sodium chloride 9 mg/mL

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead

Study Sites (1)

Vestre Viken HT, Baerum Hospital

Sandvika, Norway

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Thor Wilhelm Bjelland, MD, PhD

  Vestre Viken HT, Baerum Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 31, 2016
• Study Start: November 7, 2016
• Primary Completion: June 15, 2017
• Study Completion: December 13, 2017
• Last Updated: December 19, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)