Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients

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: Diabetic Foot; Wound Heal; Regional Anesthesia; Catheter Blockage
• Intervention / Treatment: Procedure: Group C (Continuous sciatic nerve block); Procedure: Group S (sciatic nerve block)

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	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

Collaborators and Investigators

• 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

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: Diabetic foot; Sciatic nerve catheter; wound heal
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Ulcer; Diabetic Foot
• 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