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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01415193
Other study ID # 09-02-002
Secondary ID
Status Completed
Phase N/A
First received August 1, 2011
Last updated March 17, 2015
Start date March 2009
Est. completion date December 2010

Study information

Verified date August 2011
Source Saint Francis Care
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date December 2010
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- total knee replacement

Exclusion Criteria:

- History of neuralgia, diabetes, pregnancy, allergy to local anesthetic solutions

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Selective Tibial Nerve block
Use of selective pain block.
Sciatic Nerve Block
Use of Sciatic Nerve Block

Locations

Country Name City State
United States Saint Francis Hospital and Medical Center Hartford Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Saint Francis Care

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess if selectively blocking only the tibial nerve component of the sciatic nerve will prevent foot drop. Measure frequency of foot drop in two groups and compare results. Upon emergence from general anesthesia and up to 48 hours in the recovery room. No
Secondary To assess if levels of pain and analgesic requirements are similar between the two groups. Administer pain scale and monitor use of analgesics to compare levels two groups. 24 hours after total knee replacement surgery. No
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