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

NCT02029404 | Completed DMC

• 1 other identifier: AAA-001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia Morbidity; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Compare the difference in consumption of local anesthetic in the two different groups

  within the first two days after surgery

Secondary Outcomes (1)

• 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

Other Outcomes (2)

• analyze the rate of foot drop in these two different groups

  within the first two days after surgery

• analyze the NRS in these two different groups

  within in the first two days after surgery

Study Arms (2)

Tibial nerve group

ACTIVE COMPARATOR

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.

Procedure: Tibial nerve group

Tibial peroneal nerve group

ACTIVE COMPARATOR

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.

Procedure: Tibial peroneal nerve group

Interventions

Tibial nerve group PROCEDURE

After the recovery of the sensitivity we will start the continuous infusion of levobupivacaine 0,125% with a portable pump (Mini Rythmic Evolution, Micrel Medical Devices) with a flow basal rate 2 ml/h and a rescue bolus doses of 2 ml (lock out 20 minutes). Before the discharge from the hospital, if the NRS will be \> 4, a bolus of 10 ml of Mepivacaine 1% through the catheter could be administered. An "information sheet" will be released at the discharge and the medical indication for any "rescue doses" at home. The patients will be contacted by phone at POD 1-2 and will allowed to answer to a questionnaire (see endpoint) At POD 3 the patients will come in our ambulatory where we will remove the catheter and they will return the pump

Tibial nerve group

Tibial peroneal nerve group PROCEDURE

After the recovery of the sensitivity we will start the continuous infusion of levobupivacaine 0,125% with a portable pump (Mini Rythmic Evolution ,Micrel Medical Devices )with a flow basal rate 2 ml/h and a rescue bolus doses of 2 ml (lock out 20 minutes). Before the discharge from the hospital, if the NRS will be \> 4, a bolus of 10 ml of Mepivacaine 1% through the catheter could be administered. An "information sheet" will be released at the discharge and the medical indication for any "rescue doses" at home. The patients will be contacted by phone at POD 1-2 and will allowed to answer to a questionnaire (see endpoint) At POD 3 the patients will come in our ambulatory where we will remove the catheter and they will return the pump

Tibial peroneal nerve group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale di Circolo - Fondazione Macchi: lead

Study Sites (1)

Department of Day Surgery Ospedale di Circolo Varese

Varese, VA, 21100, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Luca Guzzetti, MD

  Università degli Studi dell'Insubria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Day Surgery department Ospedale di Circolo Varese

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 7, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 8, 2015

Record last verified: 2014-10

Locations

IT (1)