NCT05351229

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Morphine Sulfate	5 mcg/kg intrathecal preservative free morphine sulfate
OTHER	Placebo	Sterile saline, placebo

Timeline

• Start date: 2023-09-29
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2022-04-28
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study