Diabetic FootNCT04212325
Efficacy of Continuous Sciatic Nerve Block in Diabetic Foot Patients
A study testing Group C (Continuous sciatic nerve block) and Group S (sciatic nerve block) in people with Diabetic Foot and Regional Anesthesia, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetic Foot, Regional Anesthesia, Catheter Blockage
- What is being tested?
- Group C (Continuous sciatic nerve block) and Group S (sciatic nerve block)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2019to 28 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing diabetic foot surgery
- spending the first postoperative night hospitalized
- age 40 years or older
Who cannot join
- inability to communicate with the investigators and hospital staff
- incarceration
- clinical neuropathy in the surgical extremity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, Keçiören, 06100
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot, Regional Anesthesia, Catheter Blockage, Wound Heal
- Being tested
- Group C (Continuous sciatic nerve block), Group S (sciatic nerve block)
- Keywords
- Diabetic foot, Sciatic nerve catheter, wound heal
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group C (Continuous sciatic nerve block)Procedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group C (Continuous sciatic nerve block) | Active comparator | 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. Receives: Procedure: Group C (Continuous sciatic nerve block) |
| Group S (sciatic nerve block) | Active comparator | 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. Receives: Procedure: Group S (sciatic nerve block) |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric rating scale (NRS)
Pain 0 (no pain) to 10 (worst pain imaginable), ranging from a numeric rating scale (NRS)
Measured: 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
Measured: 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
Measured: preoperative and postoperative 15th day
Analgesic consumption
total analgesic consumption during the postoperative 5th day
Measured: 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')
Measured: postoperative 15th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study start10 Dec 2019
- Primary completion1 Dec 2021
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Burak Eşkin, Gulhane School of Medicine
- Investigators
- Mehmet B EŞKİN, M.D., Study director, Gulhane Training and Research HospitalKerim B. Yılmaz, M.D., Principal investigator, Gulhane Training and Research HospitalGökhan Özkan, M.D., Principal investigator, Gulhane Training and Research HospitalErhan Güven, M.D., Principal investigator, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212325
- Sponsor's protocol ID
- 19/401
- Status last verified
- May 2023
- First submitted
- 20 Dec 2019
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Continuous Sciatic Nerve Block in Diabetic Foot Patients
- ClinicalTrials.gov ID
- NCT04212325
- Acronym / sponsor ID
- 19/401
- Conditions
- Diabetic Foot, Regional Anesthesia, Catheter Blockage, Wound Heal
- Keywords
- Diabetic foot, Sciatic nerve catheter, wound heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 27 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Group C (Continuous sciatic nerve block) | Active comparator | 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. |
| Group S (sciatic nerve block) | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- undergoing diabetic foot surgery
- spending the first postoperative night hospitalized
- age 40 years or older
Key exclusion criteria (3 listed)
- inability to communicate with the investigators and hospital staff
- incarceration
- clinical neuropathy in the surgical extremity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group C (Continuous sciatic nerve block) |
| 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. | Procedure or surgery | Group S (sciatic nerve block) |
Primary outcome
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)
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
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
Analgesic consumption
Time frame: during the postoperative 5th day
total analgesic consumption 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')
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehmet B EŞKİN, M.D. study director
Gulhane Training and Research Hospital
Kerim B. Yılmaz, M.D. principal investigator
Gulhane Training and Research Hospital
Gökhan Özkan, M.D. principal investigator
Gulhane Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group C (Continuous sciatic nerve block) and Group S (sciatic nerve block) in people with Diabetic Foot and Regional Anesthesia, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numeric rating scale (NRS) (time frame: three days postoperatively). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.