Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients

Gulhane School of Medicine

Status: Completed

Conditions: Diabetic Foot; Wound Heal; Catheter Blockage; Regional Anesthesia

Treatments: Procedure: Group C (Continuous sciatic nerve block); Procedure: Group S (sciatic nerve block)

Study type: Interventional

Funder types: Other

Identifiers

NCT04212325

19/401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group C (Continuous sciatic nerve block)

Active Comparator group

Description:

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.

Treatment:

Procedure: Group C (Continuous sciatic nerve block)

Group S (sciatic nerve block)

Active Comparator group

Description:

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.

Treatment:

Procedure: Group S (sciatic nerve block)