Intrathecal Morphine for Postoperative Analgesia in Video-Assisted and Robotic-Assisted Thoracic Surgery: A Randomized, Placebo-controlled, Double-blinded Clinical Trial
| Registry | NCT05351229 |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 90 (Estimated) |
| Sponsor | Northwestern University (Other) |
| Conditions | Pain, Postoperative |
| Interventions | Morphine Sulfate, Placebo (Drug, other) |
| Dates | start 2023-09-29, primary completion 2027-06-01 (estimated), completion 2027-09-01 (estimated), first posted 2022-04-28, last updated 2026-06-09 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Pain, Postoperative All trials of Morphine Sulfate All trials of Placebo
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo | Placebo comparator | Other: Placebo | Placebo, Intrathecal saline |
| Morphine | Active comparator | Drug: Morphine Sulfate | Intrathecal morphine |
Sex: All, ages: 18 Years to 80 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Chicago | Chicago, Illinois | United States | Recruiting |