NCT05351229 Intrathecal Morphine for Analgesia in Video-assisted and Robotic-assisted Thoracic Surgery
| NCT ID | NCT05351229 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Northwestern University |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2023-09-29 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 90 participants in total. It began in 2023-09-29 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05351229 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05351229 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05351229 currently recruiting?
Yes, NCT05351229 is actively recruiting participants. Contact the research team at richa.dhawan@northwestern.edu for enrollment information.
Where is the NCT05351229 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05351229 clinical trial?
NCT05351229 is sponsored by Northwestern University. The trial plans to enroll 90 participants.