Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients

May 24, 2023 updated by: Mehmet Burak Eşkin, Gulhane School of Medicine

Evaluation of the Effectiveness 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Keçiören
      • Ankara, Keçiören, Turkey, 06100
        • Gulhane Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
three days postoperatively
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
Change from Baseline arterial blood flow at postoperative 15th day
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
preoperative and postoperative 15th day
Analgesic consumption
Time Frame: during the postoperative 5th day
total analgesic consumption during the postoperative 5th day
during the postoperative 5th day
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')
postoperative 15th day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulhane School of Medicine

Investigators

  • Study Director: Mehmet B EŞKİN, M.D., Gulhane Training and Research Hospital
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

January 28, 2023

Study Registration Dates

First Submitted

December 20, 2019

First Submitted That Met QC Criteria

December 25, 2019

First Posted (Actual)

December 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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