Catheter Blockage, Diabetic Foot, Regional Anesthesia, Wound Heal
Conditions
Keywords
Diabetic foot, Sciatic nerve catheter, wound heal
Brief summary
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
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.
Interventions
PROCEDUREGroup C (Continuous sciatic nerve block)
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.
PROCEDUREGroup S (sciatic nerve block)
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.
Sponsors
Gulhane School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| numeric rating scale (NRS) | three days postoperatively | Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS) |
| Arterial blood flow | Change from Baseline arterial blood flow at postoperative 15th day | arterial tibialis posterior and arterial dorsalis pedis blood flows in the leg to be operated will be measured by doppler ultrasound |
| The Wagner Diabetic Foot Ulcer Grade Classification System | preoperative and postoperative 15th day | 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 |
| Analgesic consumption | during the postoperative 5th day | total analgesic consumption during the postoperative 5th day |
| patient satisfaction: survey | postoperative 15th day | This survey was scored on a scale from 0 to 6 (the number 0 is 'not satisfied' and the number 6 is 'extremely satisfied') |
Countries
Turkey (Türkiye)
Outcome results
None listed