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Characteristics of Popliteal Sciatic Nerve Block in Patients With and Without Diabetic Neuropathy

Primary Purpose

Diabetic Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%)
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy focused on measuring Regional anesthesia, Diabetic neuropathy, Ultrasound

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adult patients 18-85 years old
  • patients scheduled to undergo foot surgery

Exclusion Criteria

  • patients with neuropathy caused by genetic, metabolic and inflammatory diseases, as well as toxic agents and drugs (eg chemotherapy agents);
  • patients with chronic pain syndrome;
  • patients with contraindications for regional anesthesia (e.g., allergy to local anesthetics);
  • chronic consumption of opioids.

Sites / Locations

  • CHUV (Centre Hospitalier Universitaire Vaudois)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Healthy patients

Diabetic patients without neuropathy

Diabetic patients with neuropathy

Arm Description

Patients without diabetes and without peripheral neuropathy (based on the cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus <19.01 mm2)

Patients with diabetes but without peripheral neuropathy (based on the cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus <19.01 mm2)

Patients with diabetes and with peripheral neuropathy (based on the cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus > 19.01 mm2)

Outcomes

Primary Outcome Measures

Duration of analgesia

Secondary Outcome Measures

Full Information

First Posted
February 27, 2014
Last Updated
September 26, 2016
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT02076945
Brief Title
Characteristics of Popliteal Sciatic Nerve Block in Patients With and Without Diabetic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background Between 25 and 55% of diabetic patients develop neuropathy secondary to hyperglycemia. High resolution bedside ultrasound has been demonstrated to be a useful tool to detect the presence of neuropathy prior to block performance, by measuring the cross-sectional area of the posterior tibial nerve: a value superior to 19.01 mm2 at a distance of 3 cm above the medial malleolus has an optimal threshold value for identification of diabetic sensorimotor polyneuropathy. Animal data showed that duration of sciatic nerve block with local anesthetics is longer in diabetic rats compared with non-diabetic rats. Characteristics of a peripheral nerve blockade in humans with diabetic sensorimotor neuropathy are unknown. Aim The aim of this study is to compare duration of analgesia and other characteristics of an ultrasound-guided popliteal sciatic nerve block between diabetic patients with neuropathy, diabetic patients without neuropathy and non-diabetic patients without neuropathy, based on the ultrasound-measured cross-sectional area of the posterior tibial nerve. Hypothesis We hypothesize that diabetic patients with neuropathy will have a duration of analgesia lasting 50% longer than patients without neuropathy. Methods This will be an observational study on diabetic and non-diabetic patients, with and without peripheral neuropathy, based on the ultrasound-measured cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus (cut-off value, 19.01 mm2) All patients will receive ultrasound-guided sciatic nerve block with 30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%, with the needle tip positioned at the bifurcation of the sciatic nerve in peroneal and tibial nerve, below the common fascia or paraneurium. Block success will be confirmed by loss of sensation to pinprick in the distribution of the common peroneal and tibial nerves 30 minutes following local anesthetic injection. This procedure will be completed by a saphenous nerve block. Postoperative pain management will be standardized. Pain and block-related endpoints will be collected such as onset time of action of sensory and motor blockades, duration of analgesia, pain scores and opiates consumption among others. Relevance Defining the duration of analgesia in case of diabetic neuropathy will help regional anesthesiologists to better define the type and doses of drugs that will be injected and to better prescribe the postoperative multimodal analgesic treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy
Keywords
Regional anesthesia, Diabetic neuropathy, Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy patients
Arm Type
Active Comparator
Arm Description
Patients without diabetes and without peripheral neuropathy (based on the cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus <19.01 mm2)
Arm Title
Diabetic patients without neuropathy
Arm Type
Experimental
Arm Description
Patients with diabetes but without peripheral neuropathy (based on the cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus <19.01 mm2)
Arm Title
Diabetic patients with neuropathy
Arm Type
Experimental
Arm Description
Patients with diabetes and with peripheral neuropathy (based on the cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus > 19.01 mm2)
Intervention Type
Procedure
Intervention Name(s)
US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%)
Primary Outcome Measure Information:
Title
Duration of analgesia
Time Frame
with 24 hours after block performance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients 18-85 years old patients scheduled to undergo foot surgery Exclusion Criteria patients with neuropathy caused by genetic, metabolic and inflammatory diseases, as well as toxic agents and drugs (eg chemotherapy agents); patients with chronic pain syndrome; patients with contraindications for regional anesthesia (e.g., allergy to local anesthetics); chronic consumption of opioids.
Facility Information:
Facility Name
CHUV (Centre Hospitalier Universitaire Vaudois)
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

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Characteristics of Popliteal Sciatic Nerve Block in Patients With and Without Diabetic Neuropathy

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