Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313632
• Other study ID #: STUDY-23-01105
• Status: Recruiting
• Phase: Phase 3
• Start date: March 13, 2024
• Est. completion date: March 2025

Study information

• Verified date: March 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Udit Chaddha, MBBS
• Phone: 212-824-8546
• Email: udit.chaddha[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pleural Disease
• Pleural Diseases
• Postoperative Pain

Intervention

Drug:
• Bupivacaine injection
Erector spinae plane block with bupivacaine (0.5%) 30 mL once
• Placebo
ESP with matching saline placebo

Other:
• Monitored Anesthesia Care
Standard monitored anesthesia care

Locations

Country	Name	City	State
United States	Mount Sinai West Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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