Ultrasound-guided Ilioinguinal-iliohypogastric Block for... | NCT01326039

Studies
Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

NCT01326039

Sponsor

Bispebjerg Hospital

Status

Unknown status

Last Update Posted

Mar 30, 2011Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Inguinal Hernia

Interventions

bupivacaine
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

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jun 2011Estimated

Completion Date

Jul 2011Estimated

First Submitted Date

Mar 28, 2011

First Submission Date that Met QC Criteria

Mar 29, 2011

First Posted Date

Mar 30, 2011Estimated

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 29, 2011

Last Update Posted Date

Mar 30, 2011Estimated

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

Aim: To investigate whether ultrasound-guided perineural administration of 20 ml bupivacaine 5 mg/ml vs 20 ml isotonic saline at the ilioinguinal-iliohypogastric nerves have a clinically analgesic effect after unilateral open inguinal hernia repair.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bupivacaine	Active Comparator	perineural bupivacaine 5 mg/ml 20 ml	Drug: bupivacaine
saline	Placebo Comparator	perineural isotonic saline 20 ml	Drug: saline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bupivacaine	Drug	perineural bupivacaine 5 mg/ml 20 ml	bupivacaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain at mobilization using 100 mm VAS		within the first 24 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
pain at rest using 100 mm VAS		within 24 hours postoperatively
perceived illness	using short form-8 index	within 24 hours postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age above 18 years
unilateral primary inguinal repair
open surgery a.m. Lichtenstein
informed consent

Exclusion Criteria:

age below 18 years
secondary surgery
laparoscopic surgery
lack of communicative skills

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 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
Kenneth Jensen, MD	Copenhagen University Hospital Bispebjerg, Denmark	Study Chair

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine
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