A Study Investigating Properties of the Transversus Abdom... | NCT01679392

Studies
A Study Investigating Properties of the Transversus Abdominis Plane Block

NCT01679392

Sponsor

Hillerod Hospital, Denmark

Status

Completed

Last Update Posted

Mar 20, 2015Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Anesthesia, Local

Interventions

Ropivacaine

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
2011-004719-22	EudraCT Number

Status Module

Record Verification Date

Mar 2015

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

Aug 2012

Primary Completion Date

Mar 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Aug 27, 2012

First Submission Date that Met QC Criteria

Sep 5, 2012

First Posted Date

Sep 6, 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

Mar 19, 2015

Last Update Posted Date

Mar 20, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kai Henrik Wiborg Lange, Associate Professor, Hillerod Hospital, DenmarkPrincipal Investigator

Lead Sponsor

Hillerod Hospital, DenmarkOTHER

Collaborators

Not provided

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

In this study we investigate the following properties of the transversus abdominis plane block in healthy volunteers:

Cutaneous analgesic distribution
Muscular affection
Reproducibility

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ropivacaine	Experimental	Unilateral transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)	Drug: Ropivacaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ropivacaine	Drug	Unilateral, single shot, ultrasound-guided, transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)	Ropivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cutaneous analgesic distribution	Cutaneous analgesic distribution 90 min after transversus abdominis plane block administration	90 min

Secondary Outcomes

Measure	Description	Time Frame
Muscular affection of the transversus abdominis plane block	Abdominal wall muscle affection of the transversus abdominal plane block measured by ultrasonography under standardized conditions	90 min
Reproducibility of the transversus abdominis plane block

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Capable
American society of anesthesiologists classification 1 or 2
Written informed consent

Exclusion Criteria:

Age below 18 years
American society of anesthesiologists classification above 2
Body weight below 50 kg
Body mass index > 35 kg/m2
Previous abdominal surgery
Acute or chronic pain
Use of pain medication less than 24 h prior to study start
Allergy to local anesthetics
Pregnancy
Breastfeeding

Accepts Healthy Volunteers

Yes

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
Kion Bo Støving, MD	Hillerod Hospital, Denmark	Principal Investigator
Charlotte Rosenstock, MD	Hillerod Hospital, Denmark	Study Director
Kai Lange, MD	Hillerod Hospital, Denmark	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillerød Hospital		Hillerød		3400	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D000077212	Ropivacaine

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided