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

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587704
First received: December 21, 2007
Last updated: February 22, 2010
Last verified: February 2010
History of Changes
  Purpose

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

Condition Intervention
Inguinal Hernia
 Procedure: PVB using nerve stimulation
Procedure: PVB using anatomic landmarks

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Paravertebral Blocks Techniques: A Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks for Patients Undergoing Inguinal Hernia Repair

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Successful full block at T11-L1 [ Time Frame: Every 10 minutes until full block achieved ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Nerve Stimulation
Use of nerve stimulator for placement of PVB nerve block
 Procedure: PVB using nerve stimulation
5ml of 1% ropivacaine injected incrementally
Anatomic landmarks
Use of anatomic landmarks for placement of PVB block
 Procedure: PVB using anatomic landmarks
5ml of 1% ropivacaine injected incrementally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00587704

Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32216
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Steven R. Clendenen, M.D. Mayo Clinic
  More Information

Additional Information:
Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Steven R. Clendenen, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587704     History of Changes
Other Study ID Numbers: 07-002759
Study First Received: December 21, 2007
Last Updated: February 22, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on May 19, 2013