University of Chicago
Chicago, Illinois, 60637, United States
Location status: Recruiting
NCT Number: NCT05351229
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 4
Chicago, Illinois, 60637, United States
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5 mcg/kg intrathecal preservative free morphine sulfate
Sterile saline, placebo
Other names: Sterile Saline
Time frame: 24 hours after surgery
Total MG of analgesic medications given converted to morphine
Time frame: Up to 48 hours postoperative
Visual analog score between 0-10
Time frame: up to 48 hours postoperative
Number of times patient given medication for pain
Time frame: up to 48 hours postoperative
Nausea medication administration, airway events, urinary retention, pruritus medication given,
Time frame: prior to discharge from hospital, likely 1-3 days after surgery
American Pain Society Outcome Questionnaire
Time frame: 1 month and 3 months after surgery
pain intensity, location, quality via Brief Pain Inventory
Time frame: 1 month and 3 months after surgery
Questions asked via phone call at 1 month and 3 months.
Time frame: 1 month and 3 months after surgery
Questions asked via phone call at 1 month and 3 months
Contact information is provided by the study sponsor or research team.
Northwestern University
Other
Intrathecal Morphine for Postoperative Analgesia in Video-Assisted and Robotic-Assisted Thoracic Surgery: A Randomized, Placebo-controlled, Double-blinded Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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