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

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ClinicalTrials.gov Identifier: NCT00587704
Recruitment Status : Completed
First Posted : January 7, 2008
Last Update Posted : February 23, 2010
Sponsor:
Information provided by:

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:

  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 or disease Intervention/treatment
Inguinal Hernia Procedure: PVB using nerve stimulation Procedure: PVB using anatomic landmarks

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : July 2007
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Successful full block at T11-L1 [ Time Frame: Every 10 minutes until full block achieved ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Steven R. Clendenen, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587704     History of Changes
Other Study ID Numbers: 07-002759
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: February 23, 2010
Last Verified: February 2010

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