Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05351229
• Other study ID #: IRB22-0561
• Status: Recruiting
• Phase: Phase 4
• Start date: September 29, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: University of Chicago
• Contact: Richa Dhawan, MD MPH
• Phone: 773-702-1000
• Email: rdhawan[@]dacc.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Morphine Sulfate
5 mcg/kg intrathecal preservative free morphine sulfate

Other:
• Placebo
Sterile saline

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative morphine equivalent consumption	Total MG of analgesic medications given converted to morphine	24 hours after surgery
Secondary	Postoperative pain	Visual analog score between 0-10	Up to 48 hours postoperative
Secondary	Number of pain interventions	Number of times patient given medication for pain	up to 48 hours postoperative
Secondary	Postoperative opioid related side effects	Nausea medication administration, airway events, urinary retention, pruritus medication given,	up to 48 hours postoperative
Secondary	Self-reported patient satisfaction	American Pain Society Outcome Questionnaire	prior to discharge from hospital, likely 1-3 days after surgery
Secondary	pain qualities	pain intensity, location, quality via Brief Pain Inventory	1 month and 3 months after surgery
Secondary	Self reported use of analgesic medications	Questions asked via phone call at 1 month and 3 months.	1 month and 3 months after surgery
Secondary	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