Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

This study has been withdrawn prior to enrollment.

(Lack of participant recruitment)

Sponsor:

Information provided by (Responsible Party):

Antoun Nader, Northwestern University

ClinicalTrials.gov Identifier:

NCT01555216

First received: October 20, 2011

Last updated: May 25, 2016

Last verified: May 2016

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


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:

Drug Information available for: Ropivacaine monohydrochloride

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


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

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	October 20, 2011
Last Updated:	May 25, 2016
Health Authority:	United States: Institutional Review Board
Individual Participant Data
Plan to Share IPD:	No

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 Sensory System Agents Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 23, 2016

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