Approach to Continuous Sciatic Nerve Block for Orthopedic Procedures in Day Surgery With Two Different Techniques

Not Applicable

Completed

• Conditions: Regional Anesthesia Morbidity; Postoperative Pain
• Interventions: Procedure: Tibial nerve group; Procedure: Tibial peroneal nerve group

• Registration Number: NCT02029404
• Lead Sponsor: Ospedale di Circolo - Fondazione Macchi

Brief Summary

We will enroll patients submitted to feet elective orthopaedic surgery that require analgesia through continuous peripheral nerve block (CNPB) of the sciatic nerve. All catheters will be placed by anaesthesiologists experienced in ultrasound in prone positioning. The patients will be randomized in two groups with technique of sealed envelopes.

In the tibial -peroneal nerve (TPN) group we will position the catheter within the confluence of peroneal and tibial nerve.

In the tibial nerve (TN) group we will proceed , previous local anaesthesia, to insert a catheter medially to tibial branch of the sciatic nerve according to in plane approach.

We will analyze A: the difference in consumption of local anesthetic in the two different groups B: the difference of "insensate limb" in the post-operative home as described by Ilfeld(inability to perceive the sense of touch throughout the area of distribution of the sciatic nerve) C: rate of foot drop D: numeric rate scale (NRS) for pain assessment, rate of dislodgment of the catheters, patient satisfaction, need for intervention by the anesthesiologist after discharge.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Status Verified: 2014-10
• Primary Completion: 2014-12
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Patients candidates for orthopedic surgery of the lower limb in unilateral day-surgery with surgical incision in the distribution of the sciatic nerve
• Patients according to American Society of Anesthesiologists scale (ASA) I-II
• Age greater than 18 years
• Informed Consent
• Presence of a "caretaker" for the night and the next day.

Exclusion Criteria

• Contraindications to regional anesthesia
• Patients ASA III-IV
• Patients receiving therapy for chronic pain
• Patients with: renal failure, coagulopathy, liver failure, peripheral neuropathy
• Refusal by the patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tibial nerve group	Tibial nerve group	In the TN (tibial nerve ) group probe will be placed in popliteal cave to identify the popliteal artery and laterally the tibial nerve. Identified the tibial nerve we will proceed , previous local anaesthesia, to insert a catheter medially to tibial branch of the sciatic nerve according to in plane approach.
Tibial peroneal nerve group	Tibial peroneal nerve group	In the TPN (tibial -peroneal nerve) group the probe will be placed in popliteal cave to identify the popliteal artery and laterally the tibial nerve. Afterwards, proceeding cranially with the probe according to "in plane" approach, we will identify the confluence of tibial with peroneal branch and in this point, previous local anaesthesia, we will position the catheter within the confluence of peroneal and tibial nerve.

Primary Outcome Measures

Name	Time	Method
Compare the difference in consumption of local anesthetic in the two different groups	within the first two days after surgery

Secondary Outcome Measures

Name	Time	Method
Analyze the difference of "insensate limb"in the post-operative home as described by Ilfeld (inability to perceive the sense of touch throughout the area of distribution of the sciatic nerve)	within the first two days after surgery

Trial Locations

Locations (1)

Department of Day Surgery Ospedale di Circolo Varese; 🇮🇹 Varese, VA, Italy