Diabetic Foot Clinical Trial
Official title:
Evaluation of the Effectiveness of Continuous Sciatic Nerve Block in Diabetic Foot Patients
Verified date | May 2023 |
Source | Gulhane School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | January 28, 2023 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Gulhane Training and Research Hospital | Ankara | Keçiören |
Lead Sponsor | Collaborator |
---|---|
Gulhane School of Medicine |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | numeric rating scale (NRS) | Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS) | three days postoperatively | |
Primary | 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 | |
Primary | 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 | |
Primary | Analgesic consumption | total analgesic consumption during the postoperative 5th day | during the postoperative 5th day | |
Primary | 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 |
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