Postoperative Pain, Regional Anesthesia Morbidity
Conditions
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.
Interventions
PROCEDURETibial 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
PROCEDURETibial 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
Sponsors
Ospedale di Circolo - Fondazione Macchi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the difference in consumption of local anesthetic in the two different groups | within the first two days after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Analyze the difference of insensate limbin 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Outcome results
None listed