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Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

This study has been withdrawn prior to enrollment.
(Lack of participant recruitment)
Information provided by (Responsible Party):
Antoun Nader, Northwestern University Identifier:
First received: October 20, 2011
Last updated: May 25, 2016
Last verified: May 2016

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: Single injection posterior tibial nerve block Drug: Posterior tibial nerve catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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:

Further study details as provided by Antoun Nader, Northwestern University:

Primary Outcome Measures:
  • Quality of recovery [ Time Frame: Up to five days ]
    Quality of recovery

Secondary Outcome Measures:
  • Pain control (pain score) [ Time Frame: Up to 1 week ]
    pain control (pain score) between groups

  • Opioid consumption [ Time Frame: Up to 1 week ]
    Opioid consumption

  • patient satisfaction [ Time Frame: Up to 1 week ]
    patient satisfaction with pain control

Enrollment: 0
Study Start Date: October 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Posterior tibial nerve catheter
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.
Drug: Posterior tibial nerve catheter
5ml bolus of 0.5% ropivacaine with 3 ml/h of 0.2% ropivacaine with a bolus every two hours
Other Name: Naropin
Active Comparator: Single injection PTNB
Single injection posterior tibial nerve block (PTNB) of 0.5% ropivacaine
Drug: Single injection posterior tibial nerve block
5 ml of 0.5% ropivacaine
Other Name: Naropin


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01555216

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Principal Investigator: Antoun Nader, MD Northwestern Memorial Hospital
  More Information

Responsible Party: Antoun Nader, Associate Professor in Anesthesiology and Orthopaedic Surgery, Northwestern University Identifier: NCT01555216     History of Changes
Other Study ID Numbers: STU00037311
Study First Received: October 20, 2011
Last Updated: May 25, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Antoun Nader, Northwestern University:
Forefoot surgery

Additional relevant MeSH terms:
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on September 20, 2017