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NCT Number: NCT04212325

Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients

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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Catheter Blockage Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Regional Anesthesia Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases Wound Heal

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gulhane Training and Research Hospital

Ankara, Keçiören, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. numeric rating scale (NRS)

    Time frame: three days postoperatively

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

  2. Arterial blood flow

    Time frame: Change from Baseline arterial blood flow at postoperative 15th day

    arterial tibialis posterior and arterial dorsalis pedis blood flows in the leg to be operated will be measured by doppler ultrasound

  3. The Wagner Diabetic Foot Ulcer Grade Classification System

    Time frame: preoperative and postoperative 15th day

    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

  4. Analgesic consumption

    Time frame: during the postoperative 5th day

    total analgesic consumption during the postoperative 5th day

  5. patient satisfaction: survey

    Time frame: postoperative 15th day

    This survey was scored on a scale from 0 to 6 (the number 0 is 'not satisfied' and the number 6 is 'extremely satisfied')

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Official study title

Evaluation of the Effectiveness of Continuous Sciatic Nerve Block in Diabetic Foot Patients

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Dec 27, 2019
Registry last updated
May 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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