Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04212325
• Other study ID #: 19/401
• Status: Completed
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: January 28, 2023

Study information

• Verified date: May 2023
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 28, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter Blockage
• Diabetic Foot
• Regional Anesthesia
• Wound Heal

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Gulhane Training and Research Hospital	Ankara	Keçiören

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numeric rating scale (NRS)	Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)	three days postoperatively
Primary	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
Primary	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
Primary	Analgesic consumption	total analgesic consumption during the postoperative 5th day	during the postoperative 5th day
Primary	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