Skip to main content
OpenTrials
Completed

NCT Number: NCT02029404

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Regional Anesthesia Morbidity Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Day Surgery Ospedale di Circolo Varese

Varese, VA, 21100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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

Primary outcomes

  1. Compare the difference in consumption of local anesthetic in the two different groups

    Time frame: 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)

    Time frame: within the first two days after surgery

Other outcomes

  1. analyze the rate of foot drop in these two different groups

    Time frame: within the first two days after surgery

  2. analyze the NRS in these two different groups

    Time frame: within in the first two days after surgery

Sponsors and collaborators

Lead sponsor

Ospedale di Circolo - Fondazione Macchi

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Jan 7, 2014
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.