NCT00587704

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:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 7, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

February 23, 2010

Status Verified

February 1, 2010

Enrollment Period

1.8 years

First QC Date

December 21, 2007

Last Update Submit

February 22, 2010

Conditions

Inguinal Hernia

Outcome Measures

Primary Outcomes (1)

  • Successful full block at T11-L1

    Every 10 minutes until full block achieved

Study Arms (2)

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

PVB using nerve stimulationPROCEDURE

5ml of 1% ropivacaine injected incrementally

Nerve Stimulation
PVB using anatomic landmarksPROCEDURE

5ml of 1% ropivacaine injected incrementally

Anatomic landmarks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32216, United States

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Steven R. Clendenen, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 7, 2008

Study Start

July 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

February 23, 2010

Record last verified: 2010-02

Locations

US(1)