A Phase 4 interventional study of 10 mL 2% lidocaine and 10 mL preservative free saline in Pain and Amputation, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-03.
Sponsored by Northwestern University · Phase 4, Interventional, and Treatment
Participants with chronic, refractory phantom limb pain (PLP) or residual limb pain (RLP) for more than 6 months will be enrolled in this clinical trial. Aim: Define the attributable pain relief and functional improvement in participants with PLP/RLP after contralateral limb sciatic nerve block. Also, contribute to the basic science understanding of the crossed-withdraw reflex by demonstrating a known animal model phenomenon in human participants. Hypothesis: Contralateral limb sciatic nerve anesthetic block with 2% lidocaine provides immediate clinically meaningful pain reduction, defined as the proportion of patients with at least 50% improvement in numeric rating scale (NRS) pain score in PLP/RLP when compared to sham.
Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 10 mL preservative-free saline. Crossover treatment will occur 5 days after the first block.
Drug: 10 mL 2% lidocaine
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline. Crossover: Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine. Crossover treatment will occur 5 days after the first block.
Drug: 10 mL preservative free saline
Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine. Crossover treatment 5 days later using image guided sciatic nerve anesthetic block of the contralateral limb with 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 5 days later using 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
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.
Time frame: 15 minutes after treatment
One subject was screened and enrolled in this project at a dedicated Pain Center.
| Milestone | Treatment Group 2% Lidocaine | Sham Preservative Free Saline |
|---|---|---|
| Started | 0 | 1 |
| Completed | 0 | 1 |
| Not completed | 0 | 0 |
| Milestone | Treatment Group 2% Lidocaine | Sham Preservative Free Saline |
|---|---|---|
| Started | 0 | 1 |
| Completed | 0 | 1 |
| Not completed | 0 | 0 |
| Milestone | Treatment Group 2% Lidocaine | Sham Preservative Free Saline |
|---|---|---|
| Started | 0 | 1 |
| Completed | 0 | 1 |
| Not completed | 0 | 0 |
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.
| Participants | Treatment Group 2% Lidocaine | Sham Preservative Free Saline |
|---|---|---|
| Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score | 1 | 1 |
Collected over 24 hours after procedure.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group 2% Lidocaine | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Sham Preservative Free Saline | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
Project terminated early. PI leaving institution.
| Age, Continuous(Years) | Treatment Group 2% Lidocaine | Sham Preservative Free Saline | Total |
|---|---|---|---|
| Mean | — | 55 (55 to 55) | 55 (55 to 55) |
| Sex: Female, Male(Participants) | Treatment Group 2% Lidocaine | Sham Preservative Free Saline | Total |
|---|---|---|---|
| Female | 0 | 1 | 1 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment Group 2% Lidocaine | Sham Preservative Free Saline | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment Group 2% Lidocaine | Sham Preservative Free Saline | Total |
|---|---|---|---|
| United States | — | 1 | 1 |
| Height (Inches)(Inches) | Treatment Group 2% Lidocaine | Sham Preservative Free Saline | Total |
|---|---|---|---|
| Mean | — | 66 (66 to 66) | 66 (66 to 66) |
| Weight Kilograms(Kilograms) | Treatment Group 2% Lidocaine | Sham Preservative Free Saline | Total |
|---|---|---|---|
| Mean | — | 97 (97 to 97) | 97 (97 to 97) |
| Level of Amputation(Participants) | Treatment Group 2% Lidocaine | Sham Preservative Free Saline | Total |
|---|---|---|---|
| Above Knee Amputation | 0 | 1 | 1 |
| Below Knee Amputation | 0 | 0 | 0 |
| Current Pain Level(Score on a scale) | Treatment Group 2% Lidocaine | Sham Preservative Free Saline | Total |
|---|---|---|---|
| Mean | — | 6 (6 to 6) | 6 (6 to 6) |
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Northwestern University