Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy

Phase 3TerminatedNCT06313632

Icahn School of Medicine at Mount Sinai33 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pleural Disease Postoperative Pain

Interventions

Bupivacaine injectionDRUG

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

PlaceboDRUG

ESP with matching saline placebo

Monitored Anesthesia CareOTHER

Standard monitored anesthesia care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Mount Sinai West Hospital

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 hours after the intervention

Secondary Outcomes

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.

Time frame: 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.).

Time frame: 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.

Time frame: 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.

Time frame: within the first 24 hours after the intervention

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

Data from ClinicalTrials.gov

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