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Recruiting NCT05351229

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

Phase IV Interventional Pain, Postoperative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Morphine Sulfate, Placebo.
Who it may be relevant to
Registry conditions: Pain, Postoperative. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Interventions

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

Primary outcome measures

  • Postoperative morphine equivalent consumption [Time frame: 24 hours after surgery]
Secondary outcome measures (7)
  • Postoperative pain [Time frame: Up to 48 hours postoperative]
  • Number of pain interventions [Time frame: up to 48 hours postoperative]
  • Postoperative opioid related side effects [Time frame: up to 48 hours postoperative]
  • Self-reported patient satisfaction [Time frame: prior to discharge from hospital, likely 1-3 days after surgery]
  • pain qualities [Time frame: 1 month and 3 months after surgery]
  • Self reported use of analgesic medications [Time frame: 1 month and 3 months after surgery]
  • self-reported limitation of daily activity at 1 and 3 months [Time frame: 1 month and 3 months after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Chicago — Chicago

Identifiers

NCT: NCT05351229 · IRB22-0561

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗