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

Primary Purpose

Regional Anesthesia Morbidity, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Tibial nerve group
Tibial peroneal nerve group
Sponsored by
Ospedale di Circolo - Fondazione Macchi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Regional Anesthesia Morbidity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Day Surgery Ospedale di Circolo Varese

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tibial nerve group

Tibial peroneal nerve group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

Full Information

First Posted
January 6, 2014
Last Updated
April 7, 2015
Sponsor
Ospedale di Circolo - Fondazione Macchi
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1. Study Identification

Unique Protocol Identification Number
NCT02029404
Brief Title
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

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale di Circolo - Fondazione Macchi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia Morbidity, Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tibial nerve group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tibial peroneal nerve group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Tibial nerve group
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Tibial peroneal nerve group
Intervention Description
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 Outcome Measure Information:
Title
Compare the difference in consumption of local anesthetic in the two different groups
Time Frame
within the first two days after surgery
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
analyze the rate of foot drop in these two different groups
Time Frame
within the first two days after surgery
Title
analyze the NRS in these two different groups
Time Frame
within in the first two days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Guzzetti, MD
Organizational Affiliation
Università degli Studi dell'Insubria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Day Surgery Ospedale di Circolo Varese
City
Varese
State/Province
VA
ZIP/Postal Code
21100
Country
Italy

12. IPD Sharing Statement

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

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