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| Name | Class |
|---|---|
| Stanford University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| minocycline | Experimental | perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID |
|
| Placebo | Placebo Comparator | PLacebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline | Drug | RCT blinded placebo trial |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Pain Resolution | the time until patient answers no pain at surgical site for three consecutive days | up to 365 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Curtin, MD | Palo Alto Veterans Hsopital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto VA | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Minocycline | perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID for 5 days Minocycline: RCT blinded placebo trial |
| FG001 | Placebo | Placebo: two pills 2 hours prior to surgery then 1 pill BID placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Minocycline | perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID Minocycline: RCT blinded placebo trial |
| BG001 | Placebo | PLacebo placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Time to Pain Resolution | the time until patient answers no pain at surgical site for three consecutive days | 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) | Posted | Median | Full Range | DAYS | up to 365 days |
|
The patients were followed up for 6 months after surgery.
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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 | Minocycline | perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID Minocycline: RCT blinded placebo trial |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | General disorders | Non-systematic Assessment | >7/10 by self report |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Catherine Curtin | VA HCS Palo Alto | 650-493-5000 | ccurtin@stanford.edu |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| placebo | Drug | RCT blinded placebo trial |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Brief Pain Inventory(Short Form) | The Brief Pain Inventory measures two constructs. Each item is rated from 0, no pain/no interference, to 10, pain as bad as you can imagine/worst interference.
| Median | Full Range | units on a scale |
|
| screen for Posttraumatic Stess Symptoms(SPTSS) | The Brief SPTSS is a 17-item self-report measure that assesses DSM-IV symptoms of PTSD. For this survey, the respondents rated items on an 4-point scale ranging from 0 ("not at all") to 4 ("more than once everyday"). The points were sum across all items for each participant. A median score of 12 or higher has been used as the cut-off for psychological distress on this scale. [Dr. Eve Carlson personal communication] We dichotomized as low distress with a score less than 16 and high score 16 or greater. the range was from 0 to 68 points. | Median | Full Range | units on a scale |
|
| Quick Disability Arm Shoulder and Hand(qDASH) | The Quick Disability Arm Shoulder and Hand (QDASH) is a continuous variable to measure upper extremity physical function and disability. The QDASH consists of 11 items from the original 30-item DASH and has similar reliability and correlation with psychological stress as the full DASH. The scores range from 0 (best function) to 100 (worst function). | Median | Full Range | units on a scale |
|
| Beck Depression Inventory-II(BDI-II) | Beck Depression Inventory-II (BDI-II) is a widely used validated measure of depressive symptoms. It consists of 21 groups if statements. A score greater than 16 is the cutoff for depression. scoring: The sum of the score for each of the 21 questions. depression ranges: Low 1-10 Normal ups and downs 11-16 Mild mood disturbance Moderate 17-20 Borderline clinical depression 21-30 Moderate depression Significant 31-40 Severe depression Over 40 Extreme depression | Median | Full Range | units on a scale |
|
| RAND 36 Item Health Survey( short form(SF-36)) | All ques. are scored on a scale from 0(lowest)-100(highest) functioning (50 avg.) Scoring: First, recoded per the scoring key. Scores represent the percentage of total possible score achieved. Second, avg. non missing items in same scale to create 8 scale scores .Scores represent the median for all items in the scale that the respondent answered. Physical Functioning 10 Items Role Functioning/physical 4 Items Role Functioning/emotional 3 Items Energy/fatigue 4 Items Emotional well-being 5 Items Social functioning 2 Items Pain 2 Items General Health 5 Items Health Change 1 Item | Median | Full Range | units on a scale |
|
|
|
| 0 |
| 58 |
| 4 |
| 58 |
| EG001 | Placebo | PLacebo placebo | 0 | 56 | 3 | 56 |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |