Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy
- Conditions
- Postoperative PainPleural Disease
- Interventions
- Registration Number
- NCT06313632
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ESP with Placebo Monitored Anesthesia Care Erector spinae plane injection with a placebo (normal saline). ESP with Placebo Placebo Erector spinae plane injection with a placebo (normal saline). ESP with Bupivacaine Group Bupivacaine injection Erector spinae plane block with bupivacaine. ESP with Bupivacaine Group Monitored Anesthesia Care Erector spinae plane block with bupivacaine.
- Primary Outcome Measures
Name Time Method Visual Analog Scale (VAS) for Pain 2 hours after the intervention 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.
- Secondary Outcome Measures
Name Time Method Type of Analgesic use within the first 24 hours after the intervention 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.).
Change in the Numerical Rating Scale At 2 hours post-intervention and 24 hours post-intervention 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.
Number of Analgesic use within the first 24 hours after the intervention Number of Analgesics used within the first 24 hours after the intervention. The patient will be asked regarding number of doses.
Quality of Recovery-15 (QoR-15) Survey Score within the first 24 hours after the intervention 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.
Dosage of Analgesic use within the first 24 hours after the intervention Dosage of Analgesic used within the first 24 hours after the intervention. The patient will be asked regarding dose used.
Trial Locations
- Locations (1)
Mount Sinai West Hospital
🇺🇸New York, New York, United States