NCT06313632

Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy

A Triple-Blind Randomized Controlled Trial of Erector Spinae Plane Block With Bupivacaine Versus Placebo in Patients Undergoing Medical Thoracoscopy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PlAcebo versus erector spINae pLane block for mEdical ThoracoScopy Study (PAINLESS). This is a prospective triple-blind, randomized controlled trial that evaluates the efficacy of erector spinae plane block (ESPB) with Bupivacaine in reducing pain after medical thoracoscopy (MT) in addition to monitored anesthesia care vs monitored anesthesia care alone.

Detailed description

This is a single-site prospect triple-blind, randomized controlled trial, that evaluates the efficacy of erector spinae plane (ESP) block with Bupivacaine in reducing pain after medical thoracoscopy (MT). The study aims to compare the effectiveness of ESP block with monitored anesthesia care (MAC) vs MAC alone for patients undergoing MT. Patient will be evaluated post operatively in the post anesthesia care unit and 24 hours after the procedure.

Conditions

• Pleural Disease
• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine injection	Erector spinae plane block with bupivacaine (0.5%) 30 mL once
DRUG	Placebo	ESP with matching saline placebo
OTHER	Monitored Anesthesia Care	Standard monitored anesthesia care

Timeline

• Start date: 2024-03-28
• Primary completion: 2025-03-19
• Completion: 2025-03-20
• First posted: 2024-03-15
• Last updated: 2025-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study