Trial Outcomes & Findings for Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain (NCT NCT05046639)
NCT ID: NCT05046639
Last Updated: 2025-03-03
Results Overview
Proportions of Participants Reporting ≥ 50% Improvement in NRS pain score on a scale of 0 (no pain) to 10 (worst pain imaginable) from baseline at 15 minutes in treatment and sham groups.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
1 participants
Primary outcome timeframe
15 minutes after treatment
Results posted on
2025-03-03
Participant Flow
One subject was screened and enrolled in this project at a dedicated Pain Center.
1 subject was randomized and underwent a crossover treatment.
Participant milestones
| Measure |
Treatment Group 2% Lidocaine
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
First Treatment:
10 mL 2% lidocaine: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
Crossover:
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
10 mL preservative free saline: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
|
Sham Preservative Free Saline
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
First Treatment 10 mL preservative free saline: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
Crossover Treatment 10 mL 2% lidocaine: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
|
|---|---|---|
|
First Intervention
STARTED
|
0
|
1
|
|
First Intervention
COMPLETED
|
0
|
1
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout Period 5 Days
STARTED
|
0
|
1
|
|
Washout Period 5 Days
COMPLETED
|
0
|
1
|
|
Washout Period 5 Days
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Crossover)
STARTED
|
0
|
1
|
|
Second Intervention (Crossover)
COMPLETED
|
0
|
1
|
|
Second Intervention (Crossover)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sciatic Block in Contralateral Limb Phantom and Residual Limb Pain
Baseline characteristics by cohort
| Measure |
Treatment Group 2% Lidocaine
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
10 mL 2% lidocaine: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
Crossover: 10 mL preservative free saline: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
|
Sham Preservative Free Saline
n=1 Participants
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
10 mL preservative free saline: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
Crossover:10 mL 2% lidocaine: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
—
|
55 Years
n=107 Participants
|
55 Years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
—
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Height (Inches)
|
—
|
66 Inches
n=107 Participants
|
66 Inches
n=206 Participants
|
|
Weight Kilograms
|
—
|
97 Kilograms
n=107 Participants
|
97 Kilograms
n=206 Participants
|
|
Level of Amputation
Above Knee Amputation
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Level of Amputation
Below Knee Amputation
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Current Pain Level
|
—
|
6 Score on a scale
n=107 Participants
|
6 Score on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 15 minutes after treatmentPopulation: Only one participant in the trial.
Proportions of Participants Reporting ≥ 50% Improvement in NRS pain score on a scale of 0 (no pain) to 10 (worst pain imaginable) from baseline at 15 minutes in treatment and sham groups.
Outcome measures
| Measure |
Treatment Group 2% Lidocaine
n=1 Participants
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
5 days later image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
|
Sham Preservative Free Saline
n=1 Participants
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
5 Days later:Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
|
|---|---|---|
|
Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score
|
1 Participants
|
1 Participants
|
Adverse Events
Treatment Group 2% Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Preservative Free Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place