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

December 21, 2007
February 22, 2010
July 2007
May 2009   (final data collection date for primary outcome measure)
Successful full block at T11-L1 [ Time Frame: Every 10 minutes until full block achieved ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00587704 on ClinicalTrials.gov Archive Site
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Paravertebral Blocks: Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks in Inguinal Hernia Repair
Paravertebral Blocks Techniques: A Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks for Patients Undergoing Inguinal Hernia Repair

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.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Inguinal Hernia
  • Procedure: PVB using nerve stimulation
    5ml of 1% ropivacaine injected incrementally
  • Procedure: PVB using anatomic landmarks
    5ml of 1% ropivacaine injected incrementally
  • Nerve Stimulation
    Use of nerve stimulator for placement of PVB nerve block
    Intervention: Procedure: PVB using nerve stimulation
  • Anatomic landmarks
    Use of anatomic landmarks for placement of PVB block
    Intervention: Procedure: PVB using anatomic landmarks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00587704
07-002759
Not Provided
Steven R. Clendenen, M.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Steven R. Clendenen, M.D. Mayo Clinic
Mayo Clinic
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP