Trial Outcomes & Findings for Feasibility of Specific Anesthesia of the Forefoot Preserving the Sensitivity of the Heel for Foot Surgery (NCT NCT03504462)
NCT ID: NCT03504462
Last Updated: 2026-06-12
Results Overview
Pinprick and cold test on the sole of the foot - Cartography of the sole - Ipsilateral versus Contralateral test Numeric Scale for Pin-Prick test and Cold test : 2: normal sensation, 1: decreased sensation, 0: total loss of sensation Success of distal tibial nerve block is defined as complete anesthesia of the branches supplying the distal part of the foot (medial and lateral plantar nerves), with preservation of the heel : medial plantar nerve area score = 0; lateral plantar nerve area score = 0; calcaneal nerve area score = 2
COMPLETED
NA
27 participants
40 minutes
2026-06-12
Participant Flow
Participant milestones
| Measure |
Distal Tibial Nerve Block
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Distal Tibial Nerve Block
n=27 Participants
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
|
|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 18 • n=27 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=27 Participants
|
|
Type of surgery
Bunionectomy
|
8 Participants
n=27 Participants
|
|
Type of surgery
First metatarsophalangeal (MTP-1) joint arthrodesis
|
6 Participants
n=27 Participants
|
|
Type of surgery
Ingrown toenail surgery
|
4 Participants
n=27 Participants
|
|
Type of surgery
Extensor tendon synovectomy
|
1 Participants
n=27 Participants
|
|
Type of surgery
Metal implant removal
|
1 Participants
n=27 Participants
|
|
Type of surgery
Great toe tumor excision
|
1 Participants
n=27 Participants
|
|
Type of surgery
Cyst exeresis between the 3rd and the 4th metatarsals
|
1 Participants
n=27 Participants
|
|
Type of surgery
Bunionectomy + Osteotomies of the 2nd to 3rd, 4th or 5th metatarsals
|
3 Participants
n=27 Participants
|
|
Type of surgery
MTP-1 joint arthrodesis + Tenotomy on the 3rd toe
|
1 Participants
n=27 Participants
|
|
Type of surgery
Great toe tumor excision + arthroplasty on the 5th toe
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 40 minutesPinprick and cold test on the sole of the foot - Cartography of the sole - Ipsilateral versus Contralateral test Numeric Scale for Pin-Prick test and Cold test : 2: normal sensation, 1: decreased sensation, 0: total loss of sensation Success of distal tibial nerve block is defined as complete anesthesia of the branches supplying the distal part of the foot (medial and lateral plantar nerves), with preservation of the heel : medial plantar nerve area score = 0; lateral plantar nerve area score = 0; calcaneal nerve area score = 2
Outcome measures
| Measure |
Distal Tibial Nerve Block
n=27 Participants
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
|
|---|---|
|
Feasibility of a Specific Block of the Lateral and Medial Plantar Nerves
Success of distal tibial nerve block · Success of distal tibial nerve block
|
3 Participants
|
|
Feasibility of a Specific Block of the Lateral and Medial Plantar Nerves
Medial plantar nerve block · Success of distal tibial nerve block
|
23 Participants
|
|
Feasibility of a Specific Block of the Lateral and Medial Plantar Nerves
Lateral plantar nerve block · Success of distal tibial nerve block
|
3 Participants
|
|
Feasibility of a Specific Block of the Lateral and Medial Plantar Nerves
Calcaneal nerve block · Success of distal tibial nerve block
|
0 Participants
|
SECONDARY outcome
Timeframe: 40 minutesUsage (or not) of an additional anesthetic procedure to perform the surgery
Outcome measures
| Measure |
Distal Tibial Nerve Block
n=27 Participants
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
|
|---|---|
|
Feasibility of the Foot Surgery With a Specific Block of the Lateral and Medial Plantar Nerves
Need for additional anesthetic procedure
|
8 Participants
|
|
Feasibility of the Foot Surgery With a Specific Block of the Lateral and Medial Plantar Nerves
No additional anesthetic procedure
|
19 Participants
|
SECONDARY outcome
Timeframe: 40 minutesPopulation: 1 missing data
Numeric Rating Scale for Visualization : from 0 (very difficult) to 100 (very easy)
Outcome measures
| Measure |
Distal Tibial Nerve Block
n=26 Participants
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
|
|---|---|
|
Ability to Recognize Plantar Nerves Under Ultrasound
|
80 Score on a scale
Interval 60.0 to 100.0
|
SECONDARY outcome
Timeframe: At the end of surgery (2 hours maximum)Numeric Rating Scale for Satisfaction : from 0 (very unsatisfied) to 100 (very satisfied)
Outcome measures
| Measure |
Distal Tibial Nerve Block
n=27 Participants
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
|
|---|---|
|
Patient Satisfaction
|
100 Score on a scale
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: 40 minutesPopulation: 1 missing data
Numeric Rating Scale for Pain : from 0 (no pain) to 100 (severe pain)
Outcome measures
| Measure |
Distal Tibial Nerve Block
n=26 Participants
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
|
|---|---|
|
Patient Comfort During Block Performance
|
45 Score on a scale
Standard Deviation 19
|
SECONDARY outcome
Timeframe: Day 15 and Day 30 After SurgeryQuestionnaire about toe mobility, foot sensitivity and potential sensory anomalies such as numbness, itching or tingling.
Outcome measures
| Measure |
Distal Tibial Nerve Block
n=27 Participants
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
|
|---|---|
|
Complication
Day30 - Difficulty in toe mobility
|
0 Participants
|
|
Complication
Day15 - Paresthesia
|
8 Participants
|
|
Complication
Day15 - Decreased foot sensitivity
|
6 Participants
|
|
Complication
Day15 - Difficulty in toe mobility
|
1 Participants
|
|
Complication
Day15 - Edema/Hematoma
|
3 Participants
|
|
Complication
Day30 - Paresthesia
|
0 Participants
|
|
Complication
Day30 - Decreased foot sensitivity
|
0 Participants
|
|
Complication
Day30 - Edema/Hematoma
|
3 Participants
|
Adverse Events
Distal Tibial Nerve Block
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Distal Tibial Nerve Block
n=27 participants at risk
Patient receiving a specific block of medial and lateral plantar nerves in order to preserve the calcaneal nerve
|
|---|---|
|
Nervous system disorders
Paresthesia
|
29.6%
8/27 • from enrollment until end of follow-up, up to 30 days
|
|
General disorders
Edema or Hematoma
|
11.1%
3/27 • from enrollment until end of follow-up, up to 30 days
|
|
Nervous system disorders
Loss of sensation
|
22.2%
6/27 • from enrollment until end of follow-up, up to 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place