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Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01555216
Recruitment Status : Withdrawn (Lack of participant recruitment)
First Posted : March 15, 2012
Last Update Posted : May 27, 2016
Information provided by (Responsible Party):
Antoun Nader, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Hallux Valgus Drug: Single injection posterior tibial nerve block Drug: Posterior tibial nerve catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

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

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

  2. Opioid consumption [ Time Frame: Up to 1 week ]
    Opioid consumption

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01555216

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

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Responsible Party: Antoun Nader, Associate Professor in Anesthesiology and Orthopaedic Surgery, Northwestern University Identifier: NCT01555216     History of Changes
Other Study ID Numbers: STU00037311
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: May 27, 2016
Last Verified: May 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:
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Hallux Valgus
Foot Deformities
Musculoskeletal Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents