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

NCT05351229 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB22-0561
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Postoperative morphine equivalent consumption

  Total MG of analgesic medications given converted to morphine

  24 hours after surgery

Secondary Outcomes (7)

• Postoperative pain

  Up to 48 hours postoperative

• Number of pain interventions

  up to 48 hours postoperative

• Postoperative opioid related side effects

  up to 48 hours postoperative

• Self-reported patient satisfaction

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

• pain qualities

  1 month and 3 months after surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo, Intrathecal saline

Other: Placebo

Morphine

ACTIVE COMPARATOR

Intrathecal morphine

Drug: Morphine Sulfate

Interventions

Morphine Sulfate DRUG

5 mcg/kg intrathecal preservative free morphine sulfate

Morphine

Placebo OTHER

Sterile saline, placebo

Also known as: Sterile Saline

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years old
• Undergoing elective video-assisted thoracoscopic or robotic assisted surgery for anatomical lung resection
• General anesthesia with anticipated intraoperative extubation.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Central Study Contacts

Richa Dhawan, MD MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Intervention is intrathecal morphine in the intervention group. The drug is PF morphine

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 28, 2022
• Study Start: September 29, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)