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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05351229
Other study ID # IRB22-0561
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date September 29, 2023
Est. completion date December 1, 2024

Study information

Verified date November 2023
Source University of Chicago
Contact Richa Dhawan, MD MPH
Phone 773-702-1000
Email rdhawan@dacc.uchicago.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

VATS is widely used for diagnosis and treatment of intrathoracic conditions. Despite many benefits, postoperative pain continues to be intense after VATS. 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date December 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Age 18-80 years old - Undergoing elective video-assisted thoracoscopic 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Morphine Sulfate
5 mcg/kg intrathecal preservative free morphine sulfate
Other:
Placebo
Sterile saline

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative morphine equivalent consumption Total MG of analgesic medications given converted to morphine 24 hours after surgery
Secondary Postoperative pain Visual analog score between 0-10 Up to 48 hours postoperative
Secondary Number of pain interventions Number of times patient given medication for pain up to 48 hours postoperative
Secondary Postoperative opioid related side effects Nausea medication administration, airway events, urinary retention, pruritus medication given, up to 48 hours postoperative
Secondary Self-reported patient satisfaction American Pain Society Outcome Questionnaire prior to discharge from hospital, likely 1-3 days after surgery
Secondary pain qualities pain intensity, location, quality via Brief Pain Inventory 1 month and 3 months after surgery
Secondary Self reported use of analgesic medications Questions asked via phone call at 1 month and 3 months. 1 month and 3 months after surgery
Secondary self-reported limitation of daily activity at 1 and 3 months Questions asked via phone call at 1 month and 3 months 1 month and 3 months after surgery
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