Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy

Mount Sinai Health System

Status and phase: Terminated; Phase 3

Conditions: Postoperative Pain; Pleural Disease

Treatments: Drug: Placebo; Drug: Bupivacaine injection; Other: Monitored Anesthesia Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06313632

STUDY-23-01105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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33 participants in 2 patient groups

ESP with Bupivacaine Group

Experimental group

Description:

Erector spinae plane block with bupivacaine.

Treatment:

Other: Monitored Anesthesia Care

Drug: Bupivacaine injection

ESP with Placebo

Sham Comparator group

Description:

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

Treatment:

Other: Monitored Anesthesia Care

Drug: Placebo