Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery
- Registration Number
- NCT05351229
- Lead Sponsor
- University of Chicago
- Brief Summary
VATS is widely used for diagnosis and treatment of intrathoracic conditions. Despite many benefits, postoperative pain continues to be intense after VATS. 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Age 18-80 years old
- Undergoing elective video-assisted thoracoscopic surgery for anatomical lung resection
- General anesthesia with anticipated intraoperative extubation.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo, Intrathecal saline Morphine Morphine Sulfate Intrathecal morphine
- Primary Outcome Measures
Name Time Method Postoperative morphine equivalent consumption 24 hours after surgery Total MG of analgesic medications given converted to morphine
- Secondary Outcome Measures
Name Time Method 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
pain qualities 1 month and 3 months after surgery pain intensity, location, quality via Brief Pain Inventory
Self-reported patient satisfaction prior to discharge from hospital, likely 1-3 days after surgery American Pain Society Outcome Questionnaire
Self reported use of analgesic medications 1 month and 3 months after surgery Questions asked via phone call at 1 month and 3 months.
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,
Postoperative pain Up to 48 hours postoperative Visual analog score between 0-10
Trial Locations
- Locations (1)
University of Chicago
🇺🇸Chicago, Illinois, United States