NCT05351229PHASE4Recruiting

Intrathecal Morphine for Analgesia in Video-assisted and Robotic-assisted Thoracic Surgery

Northwestern University

Start Date

9/29/2023

Completion Date

9/1/2027

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

Eligibility Criteria

Age Range: 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

Interventions

DRUG

Morphine Sulfate

OTHER

Placebo

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Conditions

Pain, Postoperative

Locations

University of Chicago

Chicago, Illinois 60637

United States