Chronic Pain, Post-operative Pain
Conditions
Brief summary
The investigators are looking at whether peri-operative minocycline will reduce the duration of pain after minor hand surgery: carpal tunnel release and trigger finger release. The investigators' hypothesis is that minocycline will reduce post-operative pain.
Detailed description
This is a double blinded randomized controlled trial. Patients are given 100mg of minocycline 2 hours prior to their procedure and then 100mg two times a day for 5 days. The subjects are then contacted daily to check their level of pain. The investigators' outcome of interest is time to pain resolution. The investigators will perform a futility analysis to assess if a larger trial would be a reasonable next step after this pilot study.
Interventions
DRUGMinocycline
RCT blinded placebo trial
DRUGplacebo
RCT blinded placebo trial
Sponsors
Stanford University
VA Palo Alto Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult, Veteran,
Exclusion criteria
* Kidney failure, Liver failure, thrombocytopenia, ALS, SLE, Frailty, unable to understand survery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Pain Resolution | up to 365 days | the time until patient answers no pain at surgical site for three consecutive days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Minocycline perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID
Minocycline: RCT blinded placebo trial | 58 |
| Placebo PLacebo
placebo | 56 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | withdraw prior to treatment | 7 | 7 |
Baseline characteristics
| Characteristic | Minocycline | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 22 Participants | 43 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 34 Participants | 71 Participants |
| Age, Continuous | 60 years | 60 years | 60 years |
| Beck Depression Inventory-II(BDI-II) | 9 units on a scale | 8 units on a scale | 8 units on a scale |
| Brief Pain Inventory(Short Form) Brief Pain Inventory Interference Score | 3 units on a scale | 4 units on a scale | 3 units on a scale |
| Brief Pain Inventory(Short Form) Brief Pain Inventory Severity Score | 5 units on a scale | 5 units on a scale | 5 units on a scale |
| Quick Disability Arm Shoulder and Hand(qDASH) Arm Shoulder and Hand Play | 50 units on a scale | 56 units on a scale | 50 units on a scale |
| Quick Disability Arm Shoulder and Hand(qDASH) Arm Shoulder and Hand Work | 44 units on a scale | 44 units on a scale | 44 units on a scale |
| Quick Disability Arm Shoulder and Hand(qDASH) Quick Disability Arm Shoulder and Hand | 35 units on a scale | 45 units on a scale | 41 units on a scale |
| RAND 36 Item Health Survey( short form(SF-36)) Mental Component Score | 48 units on a scale | 47 units on a scale | 47 units on a scale |
| RAND 36 Item Health Survey( short form(SF-36)) Physical Component Score | 57 units on a scale | 58 units on a scale | 57 units on a scale |
| Region of Enrollment United States | 58 participants | 56 participants | 114 participants |
| screen for Posttraumatic Stess Symptoms(SPTSS) | 10 units on a scale | 9 units on a scale | 9 units on a scale |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 45 Participants | 47 Participants | 92 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 58 | 3 / 56 |
| serious Total, serious adverse events | 0 / 58 | 0 / 56 |
Outcome results
Primary
Time to Pain Resolution
the time until patient answers no pain at surgical site for three consecutive days
Time frame: up to 365 days
Population: 94 CTR enrolled and randomized, 83 completed and reached endpoint (43 in minocycline group and 40 in placebo group) 37 TFR enrolled and randomized, 31 completed and reached endpoint (15 in minocycline group and 16 in placebo group)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Minocycline | Time to Pain Resolution | 17 DAYS |
| Placebo | Time to Pain Resolution | 15 DAYS |