Tibial Nerve Versus Sciatic Nerve Block

• Sponsor: Saint Francis Care (Other)
• Overall Status: Completed
• CT.gov ID: NCT01415193
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Analgesia	Procedure: Selective Tibial Nerve block; Procedure: Sciatic Nerve Block	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Selective Tibial Nerve Block vs Popliteal Sciatic Nerve Block in Patients Having Total Knee Arthroplasty
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. To assess if selectively blocking only the tibial nerve component of the sciatic nerve will prevent foot drop. [Upon emergence from general anesthesia and up to 48 hours in the recovery room.]

   Measure frequency of foot drop in two groups and compare results.

Secondary Outcome Measures

1. To assess if levels of pain and analgesic requirements are similar between the two groups. [24 hours after total knee replacement surgery.]

   Administer pain scale and monitor use of analgesics to compare levels two groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• total knee replacement

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Saint Francis Care
• ClinicalTrials.gov Identifier: NCT01415193
• Other Study ID Numbers: 09-02-002
• First Posted: Aug 11, 2011
• Last Update Posted: Mar 18, 2015
• Last Verified: Aug 1, 2011

Study Results

No Results Posted as of Mar 18, 2015