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

NCT05351229 — Phase 4, Recruiting, 90 participants, Northwestern University

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

RegistryNCT05351229
StatusRecruiting
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: quadruple, prevention
Enrollment90 (Estimated)
SponsorNorthwestern University (Other)
ConditionsPain, Postoperative
InterventionsMorphine Sulfate, Placebo (Drug, other)
Datesstart 2023-09-29, primary completion 2027-06-01 (estimated), completion 2027-09-01 (estimated), first posted 2022-04-28, last updated 2026-06-09
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Pain, Postoperative All trials of Morphine Sulfate All trials of Placebo

-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.

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+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

+Arms and interventions

ArmTypeInterventionsDescription
PlaceboPlacebo comparatorOther: PlaceboPlacebo, Intrathecal saline
MorphineActive comparatorDrug: Morphine SulfateIntrathecal morphine
  • Morphine Sulfate (Drug): 5 mcg/kg intrathecal preservative free morphine sulfate
  • Placebo (Other), also known as Sterile Saline: Sterile saline, placebo

+Outcome measures

Primary outcomes

  • Postoperative morphine equivalent consumption [24 hours after surgery]: Total MG of analgesic medications given converted to morphine

Secondary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* 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 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
* Failed spinal

+Locations (1)

FacilityCityCountryStatus
University of ChicagoChicago, IllinoisUnited StatesRecruiting