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NCT Number: NCT05351229

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

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Morphine sulfate

Drug

5 mcg/kg intrathecal preservative free morphine sulfate

Placebo

Other

Sterile saline, placebo

Other names: Sterile Saline

Primary outcomes

  1. Postoperative morphine equivalent consumption

    Time frame: 24 hours after surgery

    Total MG of analgesic medications given converted to morphine

Secondary outcomes

  1. Postoperative pain

    Time frame: Up to 48 hours postoperative

    Visual analog score between 0-10

  2. Number of pain interventions

    Time frame: up to 48 hours postoperative

    Number of times patient given medication for pain

  3. Postoperative opioid related side effects

    Time frame: up to 48 hours postoperative

    Nausea medication administration, airway events, urinary retention, pruritus medication given,

  4. Self-reported patient satisfaction

    Time frame: prior to discharge from hospital, likely 1-3 days after surgery

    American Pain Society Outcome Questionnaire

  5. pain qualities

    Time frame: 1 month and 3 months after surgery

    pain intensity, location, quality via Brief Pain Inventory

  6. Self reported use of analgesic medications

    Time frame: 1 month and 3 months after surgery

    Questions asked via phone call at 1 month and 3 months.

  7. self-reported limitation of daily activity at 1 and 3 months

    Time frame: 1 month and 3 months after surgery

    Questions asked via phone call at 1 month and 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Richa Dhawan, MD MPH

CONTACT

[email protected]

312-695-0061

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 28, 2022
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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