NCT02949778

CompletedPhase 4

Quadratus Lumborum Block for Abdominoplasty

Vestre Viken Hospital Trust Source

Vestre Viken Hospital Trust

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

BS-AIO-2015-QL-block

Study Type

interventional

Actual enrollment (reported)

50

Locations

1 country

Sites

1

Timeline

Study Start

November 7, 2016

Actual (reported)

Primary Completion

June 15, 2017

Actual (reported)

Study Completion

December 13, 2017

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 50 participants
Study completion date: December 13, 2017
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
October 25, 2016
Actual (reported)
First Posted
October 31, 2016
Actual (reported)
Study Start
November 7, 2016
Actual (reported)
Primary Completion
June 15, 2017
Actual (reported)
Study Completion
December 13, 2017
Actual (reported)

Last Updated: December 19, 2017
Status Verified: December 2017
Last Update Submitted: December 18, 2017

Conditions

Abdominoplasty Pain, Postoperative

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-blockDrug: Ropivacaine

Sodium chloride 9 mg/mL

PLACEBO COMPARATOR

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

Procedure: QL-blockDrug: Sodium Chloride

Interventions

QL-blockProcedure

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/mLSodium chloride 9 mg/mL

RopivacaineDrug

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

Eligibility Criteria

Age18 Years - 64 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

American Society of Anesthesiologists Physical Classification Status (ASA) I-II
Age 18 to 64

Sponsors & Collaborators

Vestre Viken Hospital Trust
Otherlead

Study Sites (1)

Vestre Viken HT, Baerum Hospital

Sandvika, Norway

MeSH Terms

Conditions

Pain, Postoperative

Interventions

RopivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline Compounds

Study Officials

Thor Wilhelm Bjelland, MD, PhD
Vestre Viken HT, Baerum Hospital
PRINCIPAL INVESTIGATOR

Enrollment

50 participants (actual enrollment reported by the registry).

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

Actual (reported)

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Phase 4Completed

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Adductor Canal Mid-thigh and Adductor Canal Distal Thigh: Is Cutaneous Sensory Blockade Similar Among Block Techniques?

Phase 4Terminated

NCT01278264

Transversus Abdominis Plane Blocks With Abdominoplasty

Phase 4Unknown

NCT02539628

Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption

Phase 4Completed

NCT03372304

Catheter-based Peripheral Regional Anesthesia After Orthopedic Surgery to the Foot or Ankle

Phase 4Completed

NCT03372265

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Phase 4Completed

Also known as: Naropin

Ropivacaine 3.75mg/mL

Sodium ChlorideDrug

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

Sodium chloride 9 mg/mL

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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).

Contact the study team to confirm eligibility.

Amines

Chlorides

Hydrochloric Acid

Chlorine Compounds

Inorganic Chemicals

Sodium Compounds

Primary Completion

June 15, 2017

Actual (reported)

Study Completion

December 13, 2017

Actual (reported)

Last Updated

December 19, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing: Will not share

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02949778
Data provider: ClinicalTrials.gov
Source updated: 2017-12-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:01 UTC

Locations

NO(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Ropivacaine 3.75mg/mL

Sodium chloride 9 mg/mL

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations