Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

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ClinicalTrials.gov Identifier: NCT01555216

Recruitment Status : Withdrawn (Lack of participant recruitment)

First Posted : March 15, 2012

Last Update Posted : May 27, 2016

Sponsor:

Information provided by (Responsible Party):

Antoun Nader, Northwestern University

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.

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

Study Design


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

Drug Information available for: Ropivacaine monohydrochloride

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT01555216

Locations


United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators


Principal Investigator:	Antoun Nader, MD	Northwestern Memorial Hospital

More Information


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
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:


Hallux Valgus Foot Deformities Musculoskeletal Diseases Ropivacaine Anesthetics, Local	Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents

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