Quadratus Lumborum Block for Abdominoplasty | NCT02949778

Studies
Quadratus Lumborum Block for Abdominoplasty

NCT02949778

Sponsor

Vestre Viken Hospital Trust

Status

Completed

Last Update Posted

Dec 19, 2017Actual

Enrollment

50Actual

Phase

Phase 4

Conditions

Pain, Postoperative
Abdominoplasty

Interventions

QL-block
Ropivacaine
Sodium Chloride

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2016Actual

Primary Completion Date

Jun 15, 2017Actual

Completion Date

Dec 13, 2017Actual

First Submitted Date

Oct 25, 2016

First Submission Date that Met QC Criteria

Oct 27, 2016

First Posted Date

Oct 31, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2017

Last Update Posted Date

Dec 19, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
QL-block	Procedure	Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied	Ropivacaine 3.75mg/mL

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thor Wilhelm Bjelland, MD, PhD	Vestre Viken HT, Baerum Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vestre Viken HT, Baerum Hospital		Sandvika			Norway

IPD Sharing Statement Module

Plan to Share IPD

Description

Requires approval by ethics committee and second consent form.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided