Clinical trial NCT04212325: Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients
Official title: Evaluation of the Effectiveness of Continuous Sciatic Nerve Block in Diabetic Foot Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Regional Anesthesia
Catheter Blockage
Wound Heal
Keywords: Diabetic foot
Sciatic nerve catheter
wound heal
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: numeric rating scale (NRS)
timeFrame: three days postoperatively
measure: Arterial blood flow
timeFrame: Change from Baseline arterial blood flow at postoperative 15th day
measure: The Wagner Diabetic Foot Ulcer Grade Classification System
timeFrame: preoperative and postoperative 15th day
measure: Analgesic consumption
timeFrame: during the postoperative 5th day
measure: patient satisfaction: survey
timeFrame: postoperative 15th day
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
state: Keçiören
Study officials:
affiliation: Gulhane Training and Research Hospital
name: Mehmet B EŞKİN, M.D.
role: STUDY_DIRECTOR
affiliation: Gulhane Training and Research Hospital
name: Kerim B. Yılmaz, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gulhane Training and Research Hospital
name: Gökhan Özkan, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gulhane Training and Research Hospital
name: Erhan Güven, M.D.
role: PRINCIPAL_INVESTIGATOR
References: