Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery

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

VATS is widely used for diagnosis and treatment of intrathoracic conditions. Despite many benefits, postoperative pain continues to be intense after VATS. 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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Morphine Sulfate; Other: Placebo

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

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Richa Dhawan, MD MPH; Phone Number: 773-702-1000; Email: rdhawan@dacc.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Ed Fox; Phone Number: 773-834-5234; Email: efox1@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-80 years old
• Undergoing elective video-assisted thoracoscopic 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Intrathecal saline	Drug: Morphine Sulfate; 5 mcg/kg intrathecal preservative free morphine sulfate
Active Comparator: Morphine; Intrathecal morphine	Other: Placebo; Sterile saline; Other Names: Sterile Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative morphine equivalent consumption	Total MG of analgesic medications given converted to morphine	24 hours after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): April 28, 2022

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: IRB22-0561

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes