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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
90
5 mcg/kg intrathecal preservative free morphine sulfate
Sterile saline, placebo
University of Chicago
Chicago, Illinois, United States
RECRUITINGPostoperative morphine equivalent consumption
Total MG of analgesic medications given converted to morphine
Time frame: 24 hours after surgery
Postoperative pain
Visual analog score between 0-10
Time frame: Up to 48 hours postoperative
Number of pain interventions
Number of times patient given medication for pain
Time frame: up to 48 hours postoperative
Postoperative opioid related side effects
Nausea medication administration, airway events, urinary retention, pruritus medication given,
Time frame: up to 48 hours postoperative
Self-reported patient satisfaction
American Pain Society Outcome Questionnaire
Time frame: prior to discharge from hospital, likely 1-3 days after surgery
pain qualities
pain intensity, location, quality via Brief Pain Inventory
Time frame: 1 month and 3 months after surgery
Self reported use of analgesic medications
Questions asked via phone call at 1 month and 3 months.
Time frame: 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
Time frame: 1 month and 3 months after surgery
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