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Trial record 49 of 68 for:    tpn

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

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ClinicalTrials.gov Identifier: NCT02029404
Recruitment Status : Completed
First Posted : January 7, 2014
Last Update Posted : April 8, 2015
Sponsor:
Information provided by (Responsible Party):
Andrea Luigi Ambrosoli, Ospedale di Circolo - Fondazione Macchi

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.


Condition or disease Intervention/treatment Phase
Regional Anesthesia Morbidity Postoperative Pain Procedure: Tibial nerve group Procedure: Tibial peroneal nerve group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Approach to Continuous Sciatic Nerve Block for Orthopedic Procedures in Day Surgery With Two Different Techniques
Study Start Date : December 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Active Comparator: Tibial nerve group
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.
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


Active Comparator: Tibial peroneal nerve group
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.
Procedure: 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





Primary Outcome Measures :
  1. Compare the difference in consumption of local anesthetic in the two different groups [ Time Frame: within the first two days after surgery ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02029404


Locations
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Italy
Department of Day Surgery Ospedale di Circolo Varese
Varese, VA, Italy, 21100
Sponsors and Collaborators
Ospedale di Circolo - Fondazione Macchi
Investigators
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Principal Investigator: Luca Guzzetti, MD Università degli Studi dell'Insubria

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Responsible Party: Andrea Luigi Ambrosoli, Chief of Day Surgery department Ospedale di Circolo Varese, Ospedale di Circolo - Fondazione Macchi
ClinicalTrials.gov Identifier: NCT02029404     History of Changes
Other Study ID Numbers: AAA-001
First Posted: January 7, 2014    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: October 2014
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms