Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients

NCT04212325 | Completed

• 1 other identifier: 19/401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot; Regional Anesthesia; Catheter Blockage; Wound Heal

Keywords

Diabetic foot; Sciatic nerve catheter; wound heal

Outcome Measures

Primary Outcomes (5)

• numeric rating scale (NRS)

  Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)

  three days postoperatively

• 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

• 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

• Analgesic consumption

  total analgesic consumption during the postoperative 5th day

  during the postoperative 5th day

• 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

Study Arms (2)

Group C (Continuous sciatic nerve block)

ACTIVE COMPARATOR

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.

Procedure: Group C (Continuous sciatic nerve block)

Group S (sciatic nerve block)

ACTIVE COMPARATOR

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.

Procedure: Group S (sciatic nerve block)

Interventions

Group C (Continuous sciatic nerve block) 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 C (Continuous sciatic nerve block)

Group S (sciatic nerve block) 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.

Group S (sciatic nerve block)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• undergoing diabetic foot surgery
• spending the first postoperative night hospitalized
• age 40 years or older

You may not qualify if:

• inability to communicate with the investigators and hospital staff
• incarceration
• clinical neuropathy in the surgical extremity

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, Keçiören, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Mehmet B EŞKİN, M.D.

  Gulhane Training and Research Hospital

  STUDY DIRECTOR

• Kerim B. Yılmaz, M.D.

  Gulhane Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Gökhan Özkan, M.D.

  Gulhane Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Erhan Güven, M.D.

  Gulhane Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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)

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 27, 2019
• Study Start: December 10, 2019
• Primary Completion: December 1, 2021
• Study Completion: January 28, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

TU (1)