Using intrathecal morphine to manage pain after lung surgery
Intrathecal Morphine for Postoperative Analgesia in Video-Assisted and Robotic-Assisted Thoracic Surgery: A Randomized, Placebo-controlled, Double-blinded Clinical Trial
PHASE4 · Northwestern University · NCT05351229
This study is testing if a special type of morphine given directly into the spine can help reduce pain and the need for other pain medications after lung surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Northwestern University (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05351229 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intrathecal morphine for pain management in patients undergoing video-assisted thoracoscopic surgery (VATS). It is a randomized, placebo-controlled, double-blinded study where participants are assigned to receive either 5 mcg/kg of preservative-free intrathecal morphine or a placebo. The study aims to determine if morphine can reduce postoperative analgesic consumption and alleviate pain. Patients will be assessed for pain levels and medication use before discharge and through follow-up surveys at 1 and 3 months post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 undergoing elective video-assisted thoracoscopic surgery for lung resection.
Not a fit: Patients with severe comorbidities, chronic pain, or those who are allergic to morphine may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve postoperative pain management for patients undergoing lung surgery.
How similar studies have performed: Previous studies have shown promising results with intrathecal morphine for pain management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois
- University of Chicago — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Richa Dhawan, MD MPH
- Email: richa.dhawan@northwestern.edu
- Phone: 312-695-0061
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain, Postoperative