Paravertebral Blocks: Pilot Study to Compare Nerve Stimul... | NCT00587704

Studies
Paravertebral Blocks: Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks in Inguinal Hernia Repair

NCT00587704

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Feb 23, 2010Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Inguinal Hernia

Interventions

PVB using nerve stimulation
PVB using anatomic landmarks

Countries

United States

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

Feb 2010

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

Jul 2007

Primary Completion Date

May 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Dec 21, 2007

First Submission Date that Met QC Criteria

Jan 4, 2008

First Posted Date

Jan 7, 2008Estimated

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

Feb 22, 2010

Last Update Posted Date

Feb 23, 2010Estimated

Description Module

Brief Summary

Primary aim:

1. To compare the nerve stimulation vs. anatomic techniques of paravertebral block of T11-L1 in providing surgical anesthesia for patients undergoing inguinal hernia repair.

Secondary aims:

Compare VAS pain scores in the two groups of patients over the first 24 hours.
Compare opioid intake over the first 24 hours in the two groups of patients.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nerve Stimulation	Other	Use of nerve stimulator for placement of PVB nerve block	Procedure: PVB using nerve stimulation
Anatomic landmarks	Other	Use of anatomic landmarks for placement of PVB block	Procedure: PVB using anatomic landmarks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PVB using nerve stimulation	Procedure	5ml of 1% ropivacaine injected incrementally	Nerve Stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful full block at T11-L1		Every 10 minutes until full block achieved

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unilateral open inguinal herniorrhaphy
Patient must be >18 years of age
ASA physical status of I, II, or III
Patient competent to provide informed consent

Exclusion Criteria:

Patient < 18 years of age
Pregnant or lactating women
Patient unwilling or unable to provide informed consent
Contraindications to regional anesthesia
Allergy to amide local anesthetics

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
Steven R. Clendenen, M.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Jacksonville	Florida	32216	United States

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