search
Back to results

Quadratus Lumborum Block for Abdominoplasty

Primary Purpose

Pain, Postoperative, Abdominoplasty

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
QL-block
Ropivacaine
Sodium Chloride
Sponsored by
Vestre Viken Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept 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).

Sites / Locations

  • Vestre Viken HT, Baerum Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ropivacaine 3.75mg/mL

Sodium chloride 9 mg/mL

Arm Description

QL-block using 20 mL ropivacaine 3.75mg/mL

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

Outcomes

Primary Outcome Measures

Opioid consumption
total opioid consumption the first 24 postoperative hours

Secondary Outcome Measures

Full Information

First Posted
October 25, 2016
Last Updated
December 18, 2017
Sponsor
Vestre Viken Hospital Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT02949778
Brief Title
Quadratus Lumborum Block for Abdominoplasty
Official Title
Quadratus Lumborum Block for Perioperative Analgesia in Patients Treated With Abdominoplasty: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
November 7, 2016 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
December 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vestre Viken Hospital Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Abdominoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine 3.75mg/mL
Arm Type
Active Comparator
Arm Description
QL-block using 20 mL ropivacaine 3.75mg/mL
Arm Title
Sodium chloride 9 mg/mL
Arm Type
Placebo Comparator
Arm Description
QL-block using 20 mL sterile sodium chloride 9 mg/mL
Intervention Type
Procedure
Intervention Name(s)
QL-block
Other Intervention Name(s)
Quadratus lumborum block
Intervention Description
Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Ropivacaine 3.75mg/ml administered in QL-block as active treatment
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride
Intervention Description
Sodium chloride 9mg/mL administered in QL-Block as placebo
Primary Outcome Measure Information:
Title
Opioid consumption
Description
total opioid consumption the first 24 postoperative hours
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thor Wilhelm Bjelland, MD, PhD
Organizational Affiliation
Vestre Viken HT, Baerum Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vestre Viken HT, Baerum Hospital
City
Sandvika
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Requires approval by ethics committee and second consent form.

Learn more about this trial

Quadratus Lumborum Block for Abdominoplasty

We'll reach out to this number within 24 hrs