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

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.

Study Overview

• Status: Terminated
• Conditions: Postoperative Pain; Pleural Disease
• Intervention / Treatment: Drug: Bupivacaine injection; Other: Monitored Anesthesia Care; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai West Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

• Referral for medical thoracoscopy
• Age ≥ 18

Exclusion criteria:

• Inability to provide informed consent.

• Study subject has any disease or condition that interferes with safe completion of the study including:

  • Allergic reaction to Bupivacaine.
  • Need for pleurodesis.
  • Allergies to lidocaine or other local anesthetics.
  • Pregnancy.
  • Advanced liver disease where the clinician deems the procedure unsafe.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESP with Bupivacaine Group; Erector spinae plane block with bupivacaine.	Drug: Bupivacaine injection; Erector spinae plane block with bupivacaine (0.5%) 30 mL once; Other: Monitored Anesthesia Care; Standard monitored anesthesia care
Sham Comparator: ESP with Placebo; Erector spinae plane injection with a placebo (normal saline).	Other: Monitored Anesthesia Care; Standard monitored anesthesia care; Drug: Placebo; ESP with matching saline placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) for Pain	Global chest pain score measured using the Visual Analog Scale (VAS) post-procedure in recovery. Participants will be asked to mark the level of their pain along a line, score ranges 0 (no-pain) to 100 (worst-imaginable pain), with higher scores indicating worse outcomes.	2 hours after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Numerical Rating Scale	Change in chest pain measured on the numerical rating scale post-procedure in recovery versus 24 hours post-procedure. This will be done using a numerical scale from 1 to 10 (1 = very mild pain, and 10 = very severe pain), with higher scores indicating greater levels pain. Data will be collected at the time of discharge from the recovery unit (2 hours post-intervention) vs 24 hours after.	At 2 hours post-intervention and 24 hours post-intervention
Type of Analgesic use	Type of Analgesic use within the first 24 hours after the intervention. The patient will be asked regarding the types of analgesics used (i.e. non-steroidal anti-inflammatories, opioids, etc.).	within the first 24 hours after the intervention
Number of Analgesic use	Number of Analgesics used within the first 24 hours after the intervention. The patient will be asked regarding number of doses.	within the first 24 hours after the intervention
Dosage of Analgesic use	Dosage of Analgesic used within the first 24 hours after the intervention. The patient will be asked regarding dose used.	within the first 24 hours after the intervention
Quality of Recovery-15 (QoR-15) Survey Score	Compare quality of recovery 24 hours after the intervention. This will be evaluated with the QoR-15 questionnaire, scores range Minimum: 0 to Maximum: 150, with higher scores indicating a better outcome and better quality of recovery.	within the first 24 hours after the intervention

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Udit Chaddha, MBBS, Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Actual): March 19, 2025
• Study Completion (Actual): March 20, 2025

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Thoracoscopy; Regional Anesthesia; Pain Control; Erector Spinae Plane Block; Pleuroscopy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: STUDY-23-01105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will only be processed by the research team. There is no plan to share IPD and only de-identified data will be collected.

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.: No