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

Northwestern University

Status and phase: Enrolling; Phase 4

Conditions: Pain, Postoperative

Treatments: Other: Placebo; Drug: Morphine Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT05351229

IRB22-0561

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo, Intrathecal saline

Treatment:

Other: Placebo

Morphine

Active Comparator group

Description:

Intrathecal morphine

Treatment:

Drug: Morphine Sulfate