Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy

NCT06313632 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: STUDY-23-01105
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pleural Disease; Postoperative Pain

Keywords

Thoracoscopy; Pleuroscopy; Regional Anesthesia; Erector Spinae Plane Block; Pain Control

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in the Numerical Rating Scale

  At 2 hours post-intervention and 24 hours post-intervention

• Type of Analgesic use

  within the first 24 hours after the intervention

• Number of Analgesic use

  within the first 24 hours after the intervention

• Dosage of Analgesic use

  within the first 24 hours after the intervention

• Quality of Recovery-15 (QoR-15) Survey Score

  within the first 24 hours after the intervention

Study Arms (2)

ESP with Bupivacaine Group

EXPERIMENTAL

Erector spinae plane block with bupivacaine.

Drug: Bupivacaine injection; Other: Monitored Anesthesia Care

ESP with Placebo

SHAM COMPARATOR

Erector spinae plane injection with a placebo (normal saline).

Drug: Placebo; Other: Monitored Anesthesia Care

Interventions

Bupivacaine injection DRUG

Erector spinae plane block with bupivacaine (0.5%) 30 mL once

ESP with Bupivacaine Group

Placebo DRUG

ESP with matching saline placebo

ESP with Placebo

Monitored Anesthesia Care OTHER

Standard monitored anesthesia care

ESP with Bupivacaine Group; ESP with Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referral for medical thoracoscopy
• Age ≥ 18

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West Hospital

New York, New York, 10019, United States

Location

Related Publications (1)

• Luebbert E, Salguero BD, Joy G, Salman S, Lo Cascio CM, Echevarria G, Chaddha U, Pai B H P. Benefits of Using Peripheral Nerve Blocks for Medical Thoracoscopy: A Retrospective Analysis. J Bronchology Interv Pulmonol. 2025 Mar 18;32(2):e1006. doi: 10.1097/LBR.0000000000001006. eCollection 2025 Apr 1.

  PMID: 40099426 DERIVED

MeSH Terms

Conditions

Pleural Diseases; Pain, Postoperative; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Udit Chaddha, MBBS

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Triple blind study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: March 28, 2024
• Primary Completion: March 19, 2025
• Study Completion: March 20, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)