NCT01415193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
Last Updated

March 18, 2015

Status Verified

August 1, 2011

Enrollment Period

Same day

First QC Date

August 1, 2011

Last Update Submit

March 17, 2015

Conditions

Post Operative Analgesia

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • To assess if levels of pain and analgesic requirements are similar between the two groups.

    24 hours after total knee replacement surgery.

Study Arms (2)

Selective Tibial Nerve Block

EXPERIMENTAL
Procedure: Selective Tibial Nerve block

Control: Sciatic Nerve Block

ACTIVE COMPARATOR
Procedure: Sciatic Nerve Block

Interventions

Selective Tibial Nerve blockPROCEDURE

Use of selective pain block.

Selective Tibial Nerve Block
Sciatic Nerve BlockPROCEDURE

Use of Sciatic Nerve Block

Control: Sciatic Nerve Block

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • total knee replacement

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

Study Officials

  • Sanjay Sinha, MD

    Saint Francis Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2011

First Posted

August 11, 2011

Study Start

March 1, 2009

Primary Completion

March 1, 2009

Study Completion

December 1, 2010

Last Updated

March 18, 2015

Record last verified: 2011-08

Locations

US(1)