Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients

Study Overview
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Brief Summary
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Patients who underwent surgery for diabetic foot were divided into three groups: sciatic nerve block (Group B), continuous nerve catheter (Group C) . Group B patients underwent preoperative popliteal ultrasound guided peripheral nerve blockage. 20 ml of 0.25% bupivacaine was administered. In Group C patients, 20% bupivacaine 20 ml was applied to the sciatic nerve with a peripheral nerve catheter and continuous infusion was started with patient controlled analgesia device.

Detailed Description
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Ethics committee approval was received on 12 December 2019, numbered 19/344. The study was planned to include 90 adult patients undergoing diabetic foot surgery at Gülhane Training and Research Hospital between 12 December 2019 and February 2020. These patients were divided into three groups: sciatic nerve block (Group B), continuous nerve catheter (Group C). Group B patients underwent preoperative popliteal ultrasound guided peripheral nerve blockage. 20 ml of 0.25% bupivacaine was administered. In Group C patients, 20% bupivacaine 20 ml was applied to the sciatic nerve with a peripheral nerve catheter and continuous infusion was started with patient controlled analgesia device. Preoperative and postoperative blood flow of the popliteal and tibialis posterior arteries, pain scores of patients were evaluated with numeric rating scale and wound healing was monitored and recorded. The differences between the groups were compared statistically.

Official Title
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Evaluation of the Effectiveness of Continuous Sciatic Nerve Block in Diabetic Foot Patients

Conditions
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Diabetic Foot, Regional Anesthesia, Catheter Blockage, Wound Heal

Intervention / Treatment
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* Procedure: Group C (Continuous sciatic nerve block)
* Procedure: Group S (sciatic nerve block)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing diabetic foot surgery spending the first postoperative night hospitalized age 40 years or older Exclusion Criteria: inability to communicate with the investigators and hospital staff incarceration clinical neuropathy in the surgical extremity

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who will be operated due to diabetic foot will be randomized to 3 groups with continuous sciatic nerve block (Group C), single injection sciatic nerve block (Group S)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group C (Continuous sciatic nerve block)<br>Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. | Procedure: Group C (Continuous sciatic nerve block)<br>* Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. After Catheter placement outcome measures will be assessed.<br>|
| Active Comparator: Group S (sciatic nerve block)<br>Patients randomized to this group will receive a sciatic nerve block with the single injection at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. | Procedure: Group S (sciatic nerve block)<br>* Patients randomized to this group will receive a sciatic nerve block at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. After single injection sciatic nerve block, outcome measures will be assessed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numeric rating scale (NRS) | Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS) | three days postoperatively | 
| Arterial blood flow | arterial tibialis posterior and arterial dorsalis pedis blood flows in the leg to be operated will be measured by doppler ultrasound | Change from Baseline arterial blood flow at postoperative 15th day | 
| The Wagner Diabetic Foot Ulcer Grade Classification System | Grade 0 - intact Skin Grade 1 - superficial ulcer of skin or subcutaneous tissue Grade 2 - ulcers extend into tendon, bone, or capsule Grade 3 - deep ulcer with osteomyelitis, or abscess Grade 4 - partial foot gangrene Grade 5 - whole foot gangrene | preoperative and postoperative 15th day | 
| Analgesic consumption | total analgesic consumption during the postoperative 5th day | during the postoperative 5th day | 
| patient satisfaction: survey | This survey was scored on a scale from 0 to 6 (the number 0 is 'not satisfied' and the number 6 is 'extremely satisfied') | postoperative 15th day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic foot, Sciatic nerve catheter, wound heal