Recruiting

Intrathecal Morphine

Sponsor:

Northwestern University

Code:

NCT05351229

Conditions

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Morphine Sulfate

Placebo

Study Details

Brief 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.

Conditions

Pain, Postoperative

Study ID

NCT05351229

Start date

Sep 29, 2023

Status verified date

Jun, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Placebo

Placebo, Intrathecal saline

active comparator: Morphine

Intrathecal morphine

Interventions

Morphine Sulfate

5 mcg/kg intrathecal preservative free morphine sulfate

Placebo

Sterile saline, placebo

Primary outcome measure

  • Postoperative morphine equivalent consumption [ Time Frame: 24 hours after surgery ]

Central Contacts and Locations

Central contacts

Richa Dhawan, MD MPH

312-695-0061richa.dhawan@northwestern.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Ed Fox

773-834-5234efox1@bsd.uchicago.edu

More Information

Sponsor

Northwestern University

Last update posted

Jun 9, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-06-09.