Clinical trial NCT05351229: Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery
Official title: Intrathecal Morphine for Postoperative Analgesia in Video-Assisted Thoracic Surgery: A Randomized, Placebo-controlled, Double-blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention is intrathecal morphine in the intervention group. The drug is PF morphine
Primary purpose: PREVENTION

Brief 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.

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: 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

Primary outcomes:
measure: Postoperative morphine equivalent consumption
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Postoperative pain
timeFrame: Up to 48 hours postoperative
measure: Number of pain interventions
timeFrame: up to 48 hours postoperative
measure: Postoperative opioid related side effects
timeFrame: up to 48 hours postoperative
measure: Self-reported patient satisfaction
timeFrame: prior to discharge from hospital, likely 1-3 days after surgery
measure: pain qualities
timeFrame: 1 month and 3 months after surgery
measure: Self reported use of analgesic medications
timeFrame: 1 month and 3 months after surgery
measure: self-reported limitation of daily activity at 1 and 3 months
timeFrame: 1 month and 3 months after surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References: