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Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

Primary Purpose

Hallux Valgus

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single injection posterior tibial nerve block
Posterior tibial nerve catheter
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus focused on measuring Forefoot surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients (18 to 65 years old) undergoing elective scheduled forefoot surgery (hallux valgus repair and metatarsal osteotomy).

Exclusion Criteria:

  • Patient refusal to be included
  • Presence of language barrier that prohibits proper communication with patient
  • Under age of 18,
  • Pregnancy
  • History of allergy to local anesthetics or opioids
  • Presence of a progressive neurological deficit
  • Chronic opioid or drug abuse
  • Diabetes
  • Active infection in leg
  • Unstable cardiovascular, renal or hepatic disease,
  • Unwillingness to comply with follow up.

Sites / Locations

  • Northwestern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Posterior tibial nerve catheter

Single injection PTNB

Arm Description

5 ml bolus of 0.5% ropivacaine. The catheter will then be connected to a portable pump delivering 3 ml/h of 0.2% ropivacaine with a 2ml bolus every two hours.

Single injection posterior tibial nerve block (PTNB) of 0.5% ropivacaine

Outcomes

Primary Outcome Measures

Quality of recovery
Quality of recovery

Secondary Outcome Measures

Pain control (pain score)
pain control (pain score) between groups
Opioid consumption
Opioid consumption
patient satisfaction
patient satisfaction with pain control

Full Information

First Posted
October 20, 2011
Last Updated
May 25, 2016
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01555216
Brief Title
Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block
Official Title
A Randomized Comparison of a Continuous Posterior Tibial Nerve Block and Single Injection Posterior Tibial Nerve Block in Patients Undergoing Forefoot Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of participant recruitment
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Foot surgery often causes severe and prolonged pain postoperatively. Prior methods of postoperative pain control included oral narcotics, single injection regional techniques and more recently continuous nerve catheters. Recent studies have demonstrated a benefit with continuous popliteal catheters when compared to single injection techniques in regards to postoperative pain control and patient satisfaction for foot surgeries. Nerve blocks in the popliteal fossa involve both the common peroneal nerve and the tibial nerve. The innervation to the plantar surface of the forefoot involves the tibial nerve and does not involve the peroneal nerve. The purpose of this study is to compare the continuous posterior tibial nerve catheter with a single injection posterior tibial nerve block when used as part of a surgical ankle block for forefoot surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
Keywords
Forefoot surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Posterior tibial nerve catheter
Arm Type
Active Comparator
Arm Description
5 ml bolus of 0.5% ropivacaine. The catheter will then be connected to a portable pump delivering 3 ml/h of 0.2% ropivacaine with a 2ml bolus every two hours.
Arm Title
Single injection PTNB
Arm Type
Active Comparator
Arm Description
Single injection posterior tibial nerve block (PTNB) of 0.5% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Single injection posterior tibial nerve block
Other Intervention Name(s)
Naropin
Intervention Description
5 ml of 0.5% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Posterior tibial nerve catheter
Other Intervention Name(s)
Naropin
Intervention Description
5ml bolus of 0.5% ropivacaine with 3 ml/h of 0.2% ropivacaine with a bolus every two hours
Primary Outcome Measure Information:
Title
Quality of recovery
Description
Quality of recovery
Time Frame
Up to five days
Secondary Outcome Measure Information:
Title
Pain control (pain score)
Description
pain control (pain score) between groups
Time Frame
Up to 1 week
Title
Opioid consumption
Description
Opioid consumption
Time Frame
Up to 1 week
Title
patient satisfaction
Description
patient satisfaction with pain control
Time Frame
Up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (18 to 65 years old) undergoing elective scheduled forefoot surgery (hallux valgus repair and metatarsal osteotomy). Exclusion Criteria: Patient refusal to be included Presence of language barrier that prohibits proper communication with patient Under age of 18, Pregnancy History of allergy to local anesthetics or opioids Presence of a progressive neurological deficit Chronic opioid or drug abuse Diabetes Active infection in leg Unstable cardiovascular, renal or hepatic disease, Unwillingness to comply with follow up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoun Nader, MD
Organizational Affiliation
Northwestern Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

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