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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029404
• Other study ID #: AAA-001
• Status: Completed
• Phase: N/A
• First received: January 6, 2014
• Last updated: April 7, 2015
• Start date: December 2013
• Est. completion date: April 2015

Study information

• Verified date: October 2014
• Source: Ospedale di Circolo - Fondazione Macchi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Regional Anesthesia Morbidity

Intervention

Procedure:
• Tibial nerve group
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
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

Locations

Country	Name	City	State
Italy	Department of Day Surgery Ospedale di Circolo Varese	Varese	VA

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale di Circolo - Fondazione Macchi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	analyze the rate of foot drop in these two different groups		within the first two days after surgery	No
Other	analyze the NRS in these two different groups		within in the first two days after surgery	No
Primary	Compare the difference in consumption of local anesthetic in the two different groups		within the first two days after surgery	No
Secondary	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	No