Clinical trial NCT02029404: Approach to Continuous Sciatic Nerve Block for Orthopedic Procedures in Day Surgery With Two Different Techniques
Official title: Approach to Continuous Sciatic Nerve Block for Orthopedic Procedures in Day Surgery With Two Different Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia Morbidity
Postoperative Pain
Lead sponsor: Ospedale di Circolo - Fondazione Macchi
Sponsor class: OTHER
First posted: 2014-01-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compare the difference in consumption of local anesthetic in the two different groups
timeFrame: within the first two days after surgery
Secondary outcomes:
measure: 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)
timeFrame: within the first two days after surgery
Other outcomes:
measure: analyze the rate of foot drop in these two different groups
timeFrame: within the first two days after surgery
measure: analyze the NRS in these two different groups
timeFrame: within in the first two days after surgery
Locations:
city: Varese
country: Italy
facility: Department of Day Surgery Ospedale di Circolo Varese
state: VA
Study officials:
affiliation: Università degli Studi dell'Insubria
name: Luca Guzzetti, MD
role: PRINCIPAL_INVESTIGATOR
References: