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

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PVB using nerve stimulation
PVB using anatomic landmarks
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Inguinal Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Nerve Stimulation

Anatomic landmarks

Arm Description

Use of nerve stimulator for placement of PVB nerve block

Use of anatomic landmarks for placement of PVB block

Outcomes

Primary Outcome Measures

Successful full block at T11-L1

Secondary Outcome Measures

Full Information

First Posted
December 21, 2007
Last Updated
February 22, 2010
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT00587704
Brief Title
Paravertebral Blocks: Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks in Inguinal Hernia Repair
Acronym
PVB
Official Title
Paravertebral Blocks Techniques: A Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks for Patients Undergoing Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nerve Stimulation
Arm Type
Other
Arm Description
Use of nerve stimulator for placement of PVB nerve block
Arm Title
Anatomic landmarks
Arm Type
Other
Arm Description
Use of anatomic landmarks for placement of PVB block
Intervention Type
Procedure
Intervention Name(s)
PVB using nerve stimulation
Intervention Description
5ml of 1% ropivacaine injected incrementally
Intervention Type
Procedure
Intervention Name(s)
PVB using anatomic landmarks
Intervention Description
5ml of 1% ropivacaine injected incrementally
Primary Outcome Measure Information:
Title
Successful full block at T11-L1
Time Frame
Every 10 minutes until full block achieved

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R. Clendenen, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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