RecruitingPhase 4NCT05351229

Intrathecal Morphine for Analgesia in Video-assisted and Robotic-assisted Thoracic Surgery

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


Sponsor

Northwestern University

Enrollment

90 participants

Start Date

Sep 29, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • 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 Criteria17

  • 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

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Interventions

DRUGMorphine Sulfate

5 mcg/kg intrathecal preservative free morphine sulfate

OTHERPlacebo

Sterile saline, placebo


Locations(1)

University of Chicago

Chicago, Illinois, United States

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NCT05351229


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