Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy

NCT ID: NCT06313632

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-28
• Study Completion Date: 2025-03-20

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ESP with Bupivacaine Group

Erector spinae plane block with bupivacaine.

Group Type: EXPERIMENTAL

Bupivacaine injection

Intervention Type: DRUG

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

Monitored Anesthesia Care

Intervention Type: OTHER

Standard monitored anesthesia care

ESP with Placebo

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

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: DRUG

ESP with matching saline placebo

Monitored Anesthesia Care

Intervention Type: OTHER

Standard monitored anesthesia care

Interventions

Bupivacaine injection

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

Intervention Type: DRUG

Placebo

ESP with matching saline placebo

Intervention Type: DRUG

Monitored Anesthesia Care

Standard monitored anesthesia care

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Udit Chaddha

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Udit Chaddha, MBBS

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Mount Sinai West Hospital

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40099426 (View on PubMed)

Other Identifiers

STUDY-23-01105

Identifier Type: -

Identifier Source: org_study_id