Pain, Postoperative
Conditions
Brief summary
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.
Detailed description
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
Interventions
DRUGMorphine Sulfate
5 mcg/kg intrathecal preservative free morphine sulfate
OTHERPlacebo
Sterile saline, placebo
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Intervention is intrathecal morphine in the intervention group. The drug is PF morphine
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years old * Undergoing elective video-assisted thoracoscopic or robotic assisted surgery for anatomical lung resection * General anesthesia with anticipated intraoperative extubation.
Exclusion criteria
* American Society of Anesthesiologists (ASA) classification of 4 or 5 * Anticipated postoperative intubation * Significant liver disease * Preoperative use of intravenous inotropes and/or vasopressor support * Preoperative mechanical ventilation * Preoperative use of mechanical circulatory support device (intraaortic balloon pump, ventricular assist device, extracorporeal membrane oxygenation) * Severe pulmonary disease (home oxygen requirement and/or current oral steroid use) * Morphine allergy * Opioid or alcohol abuse * Chronic pain * Renal failure * Inability to comprehend English language * Bleeding disorder * Abnormal preoperative coagulation * Infection * Patient refusal * Failed spinal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morphine equivalent consumption | 24 hours after surgery | Total MG of analgesic medications given converted to morphine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | Up to 48 hours postoperative | Visual analog score between 0-10 |
| Number of pain interventions | up to 48 hours postoperative | Number of times patient given medication for pain |
| Postoperative opioid related side effects | up to 48 hours postoperative | Nausea medication administration, airway events, urinary retention, pruritus medication given, |
| Self-reported patient satisfaction | prior to discharge from hospital, likely 1-3 days after surgery | American Pain Society Outcome Questionnaire |
| pain qualities | 1 month and 3 months after surgery | pain intensity, location, quality via Brief Pain Inventory |
| Self reported use of analgesic medications | 1 month and 3 months after surgery | Questions asked via phone call at 1 month and 3 months. |
| self-reported limitation of daily activity at 1 and 3 months | 1 month and 3 months after surgery | Questions asked via phone call at 1 month and 3 months |
Countries
United States
Contacts
CONTACTRicha Dhawan, MD MPH
Outcome results
None listed