Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery

Study Overview
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Brief Summary
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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
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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

Official Title
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Intrathecal Morphine for Postoperative Analgesia in Video-Assisted Thoracic Surgery: A Randomized, Placebo-controlled, Double-blinded Clinical Trial

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Morphine Sulfate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Intrathecal saline | Drug: Morphine Sulfate<br>* 5 mcg/kg intrathecal preservative free morphine sulfate<br>|
| Active Comparator: Morphine<br>Intrathecal morphine | Other: Placebo<br>* Sterile saline<br>* Other names: Sterile Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morphine equivalent consumption | Total MG of analgesic medications given converted to morphine | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Visual analog score between 0-10 | Up to 48 hours postoperative | 
| Number of pain interventions | Number of times patient given medication for pain | up to 48 hours postoperative | 
| Postoperative opioid related side effects | Nausea medication administration, airway events, urinary retention, pruritus medication given, | up to 48 hours postoperative | 
| Self-reported patient satisfaction | American Pain Society Outcome Questionnaire | prior to discharge from hospital, likely 1-3 days after surgery | 
| pain qualities | pain intensity, location, quality via Brief Pain Inventory | 1 month and 3 months after surgery | 
| Self reported use of analgesic medications | Questions asked via phone call at 1 month and 3 months. | 1 month and 3 months after surgery | 
| 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 |