Continuous Tibial Nerve Block Versus Single Shot Tibial Nerve Block

Study Overview
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Brief Summary
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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.

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

Conditions
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Hallux Valgus

Intervention / Treatment
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* Drug: Single injection posterior tibial nerve block
* Drug: Posterior tibial nerve catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Posterior tibial nerve catheter<br>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<br>* 5ml bolus of 0.5% ropivacaine with 3 ml/h of 0.2% ropivacaine with a bolus every two hours<br>* Other names: Naropin;|
| Active Comparator: Single injection PTNB<br>Single injection posterior tibial nerve block (PTNB) of 0.5% ropivacaine | Drug: Single injection posterior tibial nerve block<br>* 5 ml of 0.5% ropivacaine<br>* Other names: Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery | Quality of recovery | Up to five days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain control (pain score) | pain control (pain score) between groups | Up to 1 week | 
| Opioid consumption | Opioid consumption | Up to 1 week | 
| patient satisfaction | patient satisfaction with pain control | Up to 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Forefoot surgery