Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

Hallux Valgus Clinical Trial

Official title:

A Randomized Comparison of a Continuous Posterior Tibial Nerve Block and Single Injection Posterior Tibial Nerve Block in Patients Undergoing Forefoot Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01555216
• Other study ID #: STU00037311
• Status: Withdrawn
• Phase: N/A
• First received: October 20, 2011
• Last updated: May 25, 2016
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: May 2016
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallux Valgus

Intervention

Drug:
• Single injection posterior tibial nerve block
5 ml of 0.5% ropivacaine
• Posterior tibial nerve catheter
5ml bolus of 0.5% ropivacaine with 3 ml/h of 0.2% ropivacaine with a bolus every two hours

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of recovery	Quality of recovery	Up to five days	No
Secondary	Pain control (pain score)	pain control (pain score) between groups	Up to 1 week	No
Secondary	Opioid consumption	Opioid consumption	Up to 1 week	No
Secondary	patient satisfaction	patient satisfaction with pain control	Up to 1 week	No