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VATS/RATS is widely used for diagnosis and treatment of intrathoracic conditions. Despite many benefits, postoperative pain continues to be intense after VATS/RATS. The optimal strategy for pain management has not been defined. In this randomized, placebo-controlled, double-blinded clinical investigation, investigators hypothesize that 5 mcg/kg intrathecal morphine will decrease postoperative analgesic consumption and reduce pain.
This is a randomized, placebo-controlled, double-blinded clinical trial. Patients will be randomized into one of two groups. Group A (Placebo, control group) will receive intrathecal sterile normal saline and Group B (Morphine group) will receive 5mcg/kg preservative free intrathecal morphine.
American Pain Society Outcome Questionnaire (APS-POQ) will be administered to patients prior to discharge (see data sheet).
Patients will be followed up with a phone survey at 1 and 3 months after surgery to assess the presence, nature, and severity of chronic persistent surgical pain. The Brief Pain Inventory is a reliable and valid measures of the interference of pain with physical functioning and will be used. Additionally patients will be asked about use of pain medications
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo, Intrathecal saline |
|
| Morphine | Active Comparator | Intrathecal morphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morphine Sulfate | Drug | 5 mcg/kg intrathecal preservative free morphine sulfate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morphine equivalent consumption | Total MG of analgesic medications given converted to morphine | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Visual analog score between 0-10 | Up to 48 hours postoperative |
| Number of pain interventions | Number of times patient given medication for pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richa Dhawan, MD MPH | Contact | 312-695-0061 | richa.dhawan@northwestern.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
Not necessary to conduct study or data analysis
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D009020 | Morphine |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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Intervention is intrathecal morphine in the intervention group. The drug is PF morphine
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| Placebo |
| Other |
Sterile saline, placebo |
|
|
| up to 48 hours postoperative |
| Postoperative opioid related side effects | Nausea medication administration, airway events, urinary retention, pruritus medication given, | up to 48 hours postoperative |
| Self-reported patient satisfaction | American Pain Society Outcome Questionnaire | prior to discharge from hospital, likely 1-3 days after surgery |
| pain qualities | pain intensity, location, quality via Brief Pain Inventory | 1 month and 3 months after surgery |
| Self reported use of analgesic medications | Questions asked via phone call at 1 month and 3 months. | 1 month and 3 months after surgery |
| self-reported limitation of daily activity at 1 and 3 months | Questions asked via phone call at 1 month and 3 months | 1 month and 3 months after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |