Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients
Primary Purpose
Diabetic Foot, Regional Anesthesia, Catheter Blockage
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group C (Continuous sciatic nerve block)
Group S (sciatic nerve block)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Foot focused on measuring Diabetic foot, Sciatic nerve catheter, wound heal
Eligibility Criteria
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
Sites / Locations
- Gulhane Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group C (Continuous sciatic nerve block)
Group S (sciatic nerve block)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
numeric rating scale (NRS)
Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)
Arterial blood flow
arterial tibialis posterior and arterial dorsalis pedis blood flows in the leg to be operated will be measured by doppler ultrasound
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
Analgesic consumption
total analgesic consumption 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')
Secondary Outcome Measures
Full Information
NCT ID
NCT04212325
First Posted
December 20, 2019
Last Updated
May 24, 2023
Sponsor
Gulhane School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04212325
Brief Title
Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients
Official Title
Evaluation of the Effectiveness of Continuous Sciatic Nerve Block in Diabetic Foot Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
January 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gulhane School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot, Regional Anesthesia, Catheter Blockage, Wound Heal
Keywords
Diabetic foot, Sciatic nerve catheter, wound heal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group C (Continuous sciatic nerve block)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group S (sciatic nerve block)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Group C (Continuous sciatic nerve block)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Group S (sciatic nerve block)
Intervention Description
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 Outcome Measure Information:
Title
numeric rating scale (NRS)
Description
Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)
Time Frame
three days postoperatively
Title
Arterial blood flow
Description
arterial tibialis posterior and arterial dorsalis pedis blood flows in the leg to be operated will be measured by doppler ultrasound
Time Frame
Change from Baseline arterial blood flow at postoperative 15th day
Title
The Wagner Diabetic Foot Ulcer Grade Classification System
Description
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
Time Frame
preoperative and postoperative 15th day
Title
Analgesic consumption
Description
total analgesic consumption during the postoperative 5th day
Time Frame
during the postoperative 5th day
Title
patient satisfaction: survey
Description
This survey was scored on a scale from 0 to 6 (the number 0 is 'not satisfied' and the number 6 is 'extremely satisfied')
Time Frame
postoperative 15th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet B EŞKİN, M.D.
Organizational Affiliation
Gulhane Training and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kerim B. Yılmaz, M.D.
Organizational Affiliation
Gulhane Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gökhan Özkan, M.D.
Organizational Affiliation
Gulhane Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erhan Güven, M.D.
Organizational Affiliation
Gulhane Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulhane Training and Research Hospital
City
Ankara
State/Province
Keçiören
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients
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