Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

NCT ID: NCT01555216

Last Updated: 2016-05-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-12-31

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.

Conditions

Hallux Valgus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Posterior tibial nerve catheter

Intervention Type: DRUG

5ml bolus of 0.5% ropivacaine with 3 ml/h of 0.2% ropivacaine with a bolus every two hours

Single injection PTNB

Single injection posterior tibial nerve block (PTNB) of 0.5% ropivacaine

Group Type: ACTIVE_COMPARATOR

Single injection posterior tibial nerve block

Intervention Type: DRUG

5 ml of 0.5% ropivacaine

Interventions

Single injection posterior tibial nerve block

5 ml of 0.5% ropivacaine

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Naropin; Naropin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Antoun Nader

Associate Professor in Anesthesiology and Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antoun Nader, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Memorial Hospital

Locations

Northwestern Memorial Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00037311

Identifier Type: -

Identifier Source: org_study_id