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Principal investigator is leaving the university.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 2% Lidocaine first, then Sham Preservative Free Saline | Experimental | 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. |
|
| Sham Preservative Free Saline first, then Treatment Group 2% Lidocaine | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 mL 2% lidocaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 minutes after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Hogue, MD | Northwestern University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17631056 | Background | Richardson C, Glenn S, Horgan M, Nurmikko T. A prospective study of factors associated with the presence of phantom limb pain six months after major lower limb amputation in patients with peripheral vascular disease. J Pain. 2007 Oct;8(10):793-801. doi: 10.1016/j.jpain.2007.05.007. Epub 2007 Jul 12. | |
| 31111898 | Background |
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1 subject was randomized and underwent a crossover treatment.
One subject was screened and enrolled in this project at a dedicated Pain Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout Period 5 Days |
| |||||||||||||
| Second Intervention (Crossover) |
|
Project terminated early. PI leaving institution.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only one participant in the trial. | Posted | Count of Participants | Participants | 15 minutes after treatment |
|
24 hours after procedure.
Only one participant was enrolled. The project was closed early due to the investigator leaving the institution.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Study closed early due to PI leaving institution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Fitzgerald | Northwestern University | 312-695-1064 | p-fitzgerald2@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2021 | Jul 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D010591 | Phantom Limb |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Prospective Randomized Crossover Controlled Trial
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Study pharmacy will prepare the study medication and it will be labeled as subject number for administration
|
| 10 mL preservative free saline | Drug | 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. |
|
| Cohen SP, Gilmore CA, Rauck RL, Lester DD, Trainer RJ, Phan T, Kapural L, North JM, Crosby ND, Boggs JW. Percutaneous Peripheral Nerve Stimulation for the Treatment of Chronic Pain Following Amputation. Mil Med. 2019 Jul 1;184(7-8):e267-e274. doi: 10.1093/milmed/usz114. |
| 16213230 | Background | Ephraim PL, Wegener ST, MacKenzie EJ, Dillingham TR, Pezzin LE. Phantom pain, residual limb pain, and back pain in amputees: results of a national survey. Arch Phys Med Rehabil. 2005 Oct;86(10):1910-9. doi: 10.1016/j.apmr.2005.03.031. |
| 19692791 | Background | Hanley MA, Ehde DM, Jensen M, Czerniecki J, Smith DG, Robinson LR. Chronic pain associated with upper-limb loss. Am J Phys Med Rehabil. 2009 Sep;88(9):742-51; quiz 752, 779. doi: 10.1097/PHM.0b013e3181b306ec. |
| 10863043 | Background | Kooijman CM, Dijkstra PU, Geertzen JHB, Elzinga A, van der Schans CP. Phantom pain and phantom sensations in upper limb amputees: an epidemiological study. Pain. 2000 Jul;87(1):33-41. doi: 10.1016/S0304-3959(00)00264-5. |
| 12551807 | Background | Dijkstra PU, Geertzen JH, Stewart R, van der Schans CP. Phantom pain and risk factors: a multivariate analysis. J Pain Symptom Manage. 2002 Dec;24(6):578-85. doi: 10.1016/s0885-3924(02)00538-9. |
| 28549447 | Background | Yin Y, Zhang L, Xiao H, Wen CB, Dai YE, Yang G, Zuo YX, Liu J. The pre-amputation pain and the postoperative deafferentation are the risk factors of phantom limb pain: a clinical survey in a sample of Chinese population. BMC Anesthesiol. 2017 May 26;17(1):69. doi: 10.1186/s12871-017-0359-6. |
| 20101187 | Background | Desmond DM, Maclachlan M. Prevalence and characteristics of phantom limb pain and residual limb pain in the long term after upper limb amputation. Int J Rehabil Res. 2010 Sep;33(3):279-82. doi: 10.1097/MRR.0b013e328336388d. |
| 18849803 | Background | Schley MT, Wilms P, Toepfner S, Schaller HP, Schmelz M, Konrad CJ, Birbaumer N. Painful and nonpainful phantom and stump sensations in acute traumatic amputees. J Trauma. 2008 Oct;65(4):858-64. doi: 10.1097/TA.0b013e31812eed9e. |
| 16691088 | Result | Richardson C, Glenn S, Nurmikko T, Horgan M. Incidence of phantom phenomena including phantom limb pain 6 months after major lower limb amputation in patients with peripheral vascular disease. Clin J Pain. 2006 May;22(4):353-8. doi: 10.1097/01.ajp.0000177793.01415.bd. |
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| NOT COMPLETED |
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| BG001 | Sham Preservative Free Saline | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height (Inches) | Mean | Full Range | Inches |
|
| Weight Kilograms | Mean | Full Range | Kilograms |
|
| Level of Amputation | Count of Participants | Participants |
|
| Current Pain Level | Numeric rating scale (NRS) provided by the participant on a scale of 0 (no pain) to 10 (worst pain imaginable). | Mean | Full Range | Score on a scale |
|
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. |
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|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Sham Preservative Free Saline | 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. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| Aniline Compounds |
| D000588 | Amines |