Dose-finding Study: Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery

Diabetic Foot Clinical Trial

Official title:

Median Effective Concentration of Ropivacaine for Ultrasound-guided Popliteal Sciatic Nerve Block in Patients Undergoing Diabetic Foot Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981067
• Other study ID #: 2102-120-1220
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Youngwon Kim, MD
• Phone: +82-2-2072-3283
• Email: youngwon.md[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to determine the minimum effective dose of a local anesthetic for proper anesthesia for popliteal sciatic nerve block under ultrasound guidance in patients undergoing surgery for diabetic foot disease.

Description:

Unlike general patients, patients with diabetic foot disease often have diabetic neuropathy and thus have increased sensitivity to local anesthetics. Therefore, when performing sciatic nerve block, it is essential to properly adjust the dose to prevent neurotoxicity and delay in recovery due to local anesthetics.

If the appropriate effective dose of local anesthetic for sciatic nerve block is found in patients with diabetic foot through this study, it is expected that it will be a useful basis for establishing a safe anesthetic method in the case of diabetic foot surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 31, 2024
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult patients who can be operated under popliteal sciatic nerve block among patients undergoing surgery for diabetic foot disease

Exclusion Criteria:

1. Infection of the popliteal region

2. Severe coagulation abnormality

3. Allergic reaction or hypersensitivity to local anesthetics

4. Neurological abnormalities other than diabetic neuropathy in the lower extremity of the operation site

5. When it is impossible to evaluate sensory blockage and motor blockage

6. When the patient refuses

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Neuropathies

Intervention

Other:
• Maintain the concentration of ropivacaine as same as those used in the previous participant
Maintain the same concentration of ropivacaine used in the previous participant with an 89% chance through a random assignment
• Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant
Decrease ropivacaine concentration by 0.05% from the concentration used in the previous participant with an 11% chance through a random assignment
• Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant
Increase ropivacaine concentration by 0.05% from the concentration used in the previous participant.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median effective anesthetic concentration 90 (MEAC 90)	Concentration of ropivacaine required for successful sciatic nerve block in 90% of all patients	within 30 minutes from the popliteal sciatic block
Secondary	Median effective anesthetic concentration 50 (MEAC 50)	Concentration of ropivacaine required for successful sciatic nerve block in 50% of all patients	within 30 minutes from the popliteal sciatic block
Secondary	Sensory block onset time	Check for sensory blockade every 5 minutes until 30 minutes after block performed. For sensory block, cold sense using alcohol swabs is evaluated on the foot, comparing with the opposite foot, on a 3-point scale (0 points if there is no cold sense at all, 1 point if there is a decrease, 2 points if it is the same with the opposite foot).; The time it takes to block to 0 point is the sensory blockade onset time.	within 30 minutes from the popliteal sciatic block
Secondary	Motor block onset time	Check for motor blockade every 5 minutes until 30 minutes after block performed. Dorsiflexion and plantar flexion is evaluated, compared to the opposite foot, on a 3-point scale (0 points for inability to move 1 point for reduced movement 2 points for normal movement).; The time it takes to block to 0 point is the motor blockade onset time.	within 30 minutes from the popliteal sciatic block
Secondary	Block duration	Block duration is the time from when block is performed until the patient first complained of pain at the surgical site post-operatively.	within 24 hours post-operatively
Secondary	Time to first rescue analgesia	Time to first rescue analgesia is the time from when block is performed until the patient first requested of rescue analgesics post-operatively.	within 24 hours post-operatively
Secondary	Any adverse events	Unintentional nerve damage that occurs during nerve block, pain, bleeding, infection, hypoxia, hypotension	within 24 hours post-operatively