Amputation, Pain
Conditions
Keywords
Pain, Amputation, Phantom Pain
Brief summary
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.
Interventions
DRUG10 mL 2% lidocaine
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.
DRUG10 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.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Study pharmacy will prepare the study medication and it will be labeled as subject number for administration
Intervention model description
Prospective Randomized Crossover Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Age greater than 18 years of age at day of enrollment * 2\. Lower extremity amputation performed more than 12 months before study enrollment * 3\. PLP/RLP in affected amputated limb \> 4 on numeric rating scale 26 (NRS26) * 4\. Pain duration of more than 6 months despite a trial of conservative therapies for at least 2 months, including oral medications, topical medicines, physical therapy, and physical modalities (i.e., heat, cold, transcutaneous electrical nerve stimulation, phonophoresis) * 5\. Willingness to undergo image guided diagnostic nerve block
Exclusion criteria
* 1\. Refusal / inability to participate or provide consent * 2\. Contraindications to diagnostic nerve block * 3\. Non-neurogenic source of PLP/RLP * 4\. Current opioid use \> 50 morphine milligram equivalents per day * 5\. Any interventional pain treatment in the residual limb within the last 30 days * 6\. Severe uncontrolled medical condition (i.e., hypertensive crisis, decompensated hypothyroidism) * 7\. Use of investigational pain drug within past 30 days or other concurrent clinical trial enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score | 15 minutes after treatment | 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. |
Countries
United States
Participant flow
Recruitment details
One subject was screened and enrolled in this project at a dedicated Pain Center.
Pre-assignment details
1 subject was randomized and underwent a crossover treatment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Sham Preservative Free Saline | Total | Treatment Group 2% Lidocaine |
|---|---|---|---|
| Age, Continuous | 55 Years | 55 Years | — |
| Current Pain Level | 6 Score on a scale | 6 Score on a scale | — |
| Height (Inches) | 66 Inches | 66 Inches | — |
| Level of Amputation Above Knee Amputation | 1 Participants | 1 Participants | 0 Participants |
| Level of Amputation Below Knee Amputation | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants | — |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight Kilograms | 97 Kilograms | 97 Kilograms | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
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.
Time frame: 15 minutes after treatment
Population: Only one participant in the trial.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Group 2% Lidocaine | Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score | 1 Participants |
| Sham Preservative Free Saline | Number of Participants Reporting ≥ 50% Improvement in NRS Pain Score | 1 Participants |