Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients

NCT ID: NCT04212325

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-10
• Study Completion Date: 2023-01-28

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.

Conditions

Diabetic Foot; Regional Anesthesia; Catheter Blockage; Wound Heal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 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.

Group Type: ACTIVE_COMPARATOR

Group C (Continuous sciatic nerve block)

Intervention Type: PROCEDURE

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.

Group S (sciatic nerve block)

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.

Group Type: ACTIVE_COMPARATOR

Group S (sciatic nerve block)

Intervention Type: PROCEDURE

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.

Interventions

Group 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.

Intervention Type: PROCEDURE

Group 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gulhane School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Burak Eşkin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet B EŞKİN, M.D.

Role: STUDY_DIRECTOR

Gulhane Training and Research Hospital

Kerim B. Yılmaz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gulhane Training and Research Hospital

Gökhan Özkan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gulhane Training and Research Hospital

Erhan Güven, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gulhane Training and Research Hospital

Locations

Gulhane Training and Research Hospital

Ankara, Keçiören, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

19/401

Identifier Type: -

Identifier Source: org_study_id