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Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

This study is currently recruiting participants.
Verified June 2012 by Northwestern University
Sponsor:
Information provided by (Responsible Party):
Antoun Nader, Northwestern University
ClinicalTrials.gov Identifier:
NCT01555216
First received: October 20, 2011
Last updated: June 7, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Hallux Valgus
 Drug: Ropivacaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Comparison of a Continuous Posterior Tibial Nerve Block and Single Injection Posterior Tibial Nerve Block in Patients Undergoing Forefoot Surgery

Resource links provided by NLM:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Quality of recovery [ Time Frame: Up to five days ] [ Designated as safety issue: No ]
    Quality of recovery


Secondary Outcome Measures:
  • Pain control (pain score) [ Time Frame: Up to 1 week ] [ Designated as safety issue: No ]
    pain control (pain score) between groups

  • Opioid consumption [ Time Frame: Up to 1 week ] [ Designated as safety issue: No ]
    Opioid consumption

  • patient satisfaction [ Time Frame: Up to 1 week ] [ Designated as safety issue: No ]
    patient satisfaction with pain control


Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Posterior tibial nerve catheter
Posterior tibial nerve catheter connected to a portable pump
 Drug: Ropivacaine
3 ml/h of 0.2% ropivacaine with a bolus every two hours
Active Comparator: Single injection posterior tibial nerve block
Single injection posterior tibial nerve block of 0.5% ropivacaine
 Drug: Ropivacaine
5 ml of 0.5% ropivacaine

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01555216

Contacts
Contact: Mark Kendall, MD 312-926-5278 m-kendall@northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Mark Kendall, M.D.     312-926-5278     m-kendall@northwester.edu    
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Antoun Nader, MD Northwestern Memorial Hospital
  More Information

No publications provided

Responsible Party: Antoun Nader, Associate Professor in Anesthesiology and Orthopaedic Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01555216     History of Changes
Other Study ID Numbers: STU00037311
Study First Received: October 20, 2011
Last Updated: June 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Forefoot surgery

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013