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

Not Applicable

Active, not recruiting

• Conditions: Diabetic Neuropathies; Diabetic Foot
• Interventions: Other: Maintain the concentration of ropivacaine as same as those used in the previous participant; Other: Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant; Other: Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant

• Registration Number: NCT04981067
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-28
• Study Start: 2021-08-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29
• Primary Completion: 2026-12-28
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Sciatic nerve block using same or decreased concentration of local anesthetic	Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant	If the sciatic nerve block in the previous participant was successful, the concentration of local anesthetic would be maintained or decreased 0.05% in the next patient based on a random assignment.
Sciatic nerve block using same or decreased concentration of local anesthetic	Maintain the concentration of ropivacaine as same as those used in the previous participant	If the sciatic nerve block in the previous participant was successful, the concentration of local anesthetic would be maintained or decreased 0.05% in the next patient based on a random assignment.
Sciatic nerve block using increased concentration of local anesthetic	Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant	If the sciatic nerve block in the previous participant was not successful, the concentration of local anesthetic would be increased 0.05% in the next patient.

Primary Outcome Measures

Name	Time	Method
Median effective anesthetic concentration 90 (MEAC 90)	within 30 minutes from the popliteal sciatic block	Concentration of ropivacaine required for successful sciatic nerve block in 90% of all patients

Secondary Outcome Measures

Name	Time	Method
Motor block onset time	within 30 minutes from the popliteal sciatic block	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.
Block duration	within 24 hours post-operatively	Block duration is the time from when block is performed until the patient first complained of pain at the surgical site post-operatively.
Any adverse events	within 24 hours post-operatively	Unintentional nerve damage that occurs during nerve block, pain, bleeding, infection, hypoxia, hypotension
Time to first rescue analgesia	within 24 hours post-operatively	Time to first rescue analgesia is the time from when block is performed until the patient first requested of rescue analgesics post-operatively.
Median effective anesthetic concentration 50 (MEAC 50)	within 30 minutes from the popliteal sciatic block	Concentration of ropivacaine required for successful sciatic nerve block in 50% of all patients
Sensory block onset time	within 30 minutes from the popliteal sciatic block	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.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of