Tibial Nerve Versus Sciatic Nerve Block

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Saint Francis Care
ClinicalTrials.gov Identifier:
NCT01415193
First received: August 1, 2011
Last updated: May 29, 2013
Last verified: August 2011
  Purpose

The purpose of this study is to analyse the ability to selectively block the posterior tibial nerve sparing the function of the common peritoneal nerve. To assess the efficacy of blocking the posterior tibial nerve will give the same post-operative pain relief after total knee surgery compared to a sciatic nerve block.


Condition Intervention
Post Operative Analgesia
Procedure: Selective Tibial Nerve block
Procedure: Sciatic Nerve Block

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Selective Tibial Nerve Block vs Popliteal Sciatic Nerve Block in Patients Having Total Knee Arthroplasty

Further study details as provided by Saint Francis Care:

Primary Outcome Measures:
  • To assess if selectively blocking only the tibial nerve component of the sciatic nerve will prevent foot drop. [ Time Frame: Upon emergence from general anesthesia and up to 48 hours in the recovery room. ] [ Designated as safety issue: No ]
    Measure frequency of foot drop in two groups and compare results.


Secondary Outcome Measures:
  • To assess if levels of pain and analgesic requirements are similar between the two groups. [ Time Frame: 24 hours after total knee replacement surgery. ] [ Designated as safety issue: No ]
    Administer pain scale and monitor use of analgesics to compare levels two groups.


Enrollment: 80
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Selective Tibial Nerve Block Procedure: Selective Tibial Nerve block
Use of selective pain block.
Active Comparator: Control: Sciatic Nerve Block Procedure: Sciatic Nerve Block
Use of Sciatic Nerve Block

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • total knee replacement

Exclusion Criteria:

  • History of neuralgia, diabetes, pregnancy, allergy to local anesthetic solutions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415193

Locations
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Sponsors and Collaborators
Saint Francis Care
Investigators
Principal Investigator: Sanjay Sinha, MD Saint Francis Memorial Hospital
  More Information

No publications provided

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT01415193     History of Changes
Other Study ID Numbers: 009-02-002
Study First Received: August 1, 2011
Last Updated: May 29, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 20, 2014