Transmuscular Quadratus Lumborum Block for Laparoscopic C... | NCT02225418

Studies
Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy

NCT02225418

Sponsor

Jens Borglum Neimann

Status

Withdrawn

Last Update Posted

Jul 22, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cholecystitis
Pain

Interventions

Ropivacaine
saline

Countries

Denmark

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

ID	Type	Description	Link
2013-001364-30	EudraCT Number

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Change of jobs

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Nov 2015Estimated

Completion Date

Not provided

First Submitted Date

Jan 28, 2014

First Submission Date that Met QC Criteria

Aug 25, 2014

First Posted Date

Aug 26, 2014Estimated

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

Jul 20, 2015

Last Update Posted Date

Jul 22, 2015Estimated

Name	Class
Bispebjerg Hospital	OTHER

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

The TQL block may prove a valuable method for treating postoperative pain following scopic removal of the gall bladder.

The trial will compare active TQL block versus placebo TQL block after said operation.

The hypothesis is that active TQL block significantly will reduce postoperative pain following scopic removal of the gall bladder compared with placebo TQL block.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo TQL block	Sham Comparator	30 ml single shot TQL block with saline 0,9%	Drug: saline
Active TQL block	Active Comparator	30 ml single shot TQL block with ropivacaine 0,75%	Drug: Ropivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine	Drug		Active TQL block	naropin
saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain score in sitting position	Numerical Rating Scale (NRS) score 1 hour after administration of TQL block	1 hour

Secondary Outcomes

Measure	Description	Time Frame
Pain score at rest	NRS score after administration of TQL block at said time points	15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour
Pain score at sitting position	NRS score after administration of TQL block at said time points

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

scheduled for elective laparoscopic cholecystectomy
received oral and written information about the trial
American Society of Anaethesiologists (ASA) classification 1-3
NRS score > 3 upon arrival at the PACU area

Exclusion Criteria:

Cannot cooperate
Does not speak or understand Danish
Allergy towards drugs used in the trial
Large daily consumption of opioids
Known alcohol og medicin abuse
Difficult or impossible by ultrasound to visualise the intended nerve/tissue structures necessary to perform block
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Børglum, MD, PhD	University Hospital Bispebjerg and Frederiksberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bispebjerg Hospital		Copenhagen		2400 NV	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D002764	Cholecystitis
D010146	Pain

Ancestor Terms

ID	Term
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D009461	Neurologic Manifestations

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