Transversus Abdominis Plane Block After Robot-assisted La... | NCT01504386

Studies
Transversus Abdominis Plane Block After Robot-assisted Laparocopic Hysterectomy

NCT01504386

Sponsor

Copenhagen University Hospital at Herlev

Status

Terminated

Last Update Posted

Aug 22, 2013Estimated

Enrollment

70Actual

Phase

Phase 4

Conditions

Hysterectomy

Interventions

TAP block
Placebo TAP block

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

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to local restructering, further recruting was not possible

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Dec 30, 2011

First Submission Date that Met QC Criteria

Jan 3, 2012

First Posted Date

Jan 5, 2012Estimated

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

Aug 21, 2013

Last Update Posted Date

Aug 22, 2013Estimated

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 purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane (TAP) block as a part of a multimodal postoperative pain management after robot-assisted laparoscopic hysterecomy.

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

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TAP block	Experimental	TAP block with ropivacaine	Procedure: TAP block
Placebo TAP block	Placebo Comparator	Sham block with saline	Procedure: Placebo TAP block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAP block	Procedure	Bilateral UL-guided TAP block with 20 ml of ropivacaine 0.5 %	TAP block

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total opioid consumption	Opioid consumption via PCA-pump	0-24 hours

Secondary Outcomes

Measure	Description	Time Frame
Pain during rest and cough	VAS-pain score at rest and at cough	1,2,4,8,18 and 24 hours
Postoperative nausea and vomiting	Nausea score 0-3 No. of vomits

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-80
BMI 17-40
Written consent
Can cooperate

Exclusion Criteria:

Drug and alcohol abuse
Consumption of opioids
Drug allergy
Infection at insertion point of needle

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henrik Torup, MD	Herlev University Hospital, Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Herlev Univerity Hospital, Department of Anaesthesia		Herlev		2730	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided