Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

NCT01555216 | Withdrawn

• 1 other identifier: STU00037311
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

Forefoot surgery

Outcome Measures

Primary Outcomes (1)

• Quality of recovery

  Quality of recovery

  Up to five days

Secondary Outcomes (3)

• Pain control (pain score)

  Up to 1 week

• Opioid consumption

  Up to 1 week

• patient satisfaction

  Up to 1 week

Study Arms (2)

Posterior tibial nerve catheter

ACTIVE COMPARATOR

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

Single injection PTNB

ACTIVE COMPARATOR

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

Drug: Single injection posterior tibial nerve block

Interventions

Single injection posterior tibial nerve block DRUG

5 ml of 0.5% ropivacaine

Also known as: Naropin

Single injection PTNB

Posterior tibial nerve catheter DRUG

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

Also known as: Naropin

Posterior tibial nerve catheter

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (18 to 65 years old) undergoing elective scheduled forefoot surgery (hallux valgus repair and metatarsal osteotomy).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Hallux Valgus

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Antoun Nader, MD

  Northwestern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Anesthesiology and Orthopaedic Surgery

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: March 15, 2012
• Study Start: October 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 27, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)