Pleural Disease, Postoperative Pain
Conditions
Keywords
Thoracoscopy, Pleuroscopy, Regional Anesthesia, Erector Spinae Plane Block, Pain Control
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.
Interventions
DRUGBupivacaine injection
Erector spinae plane block with bupivacaine (0.5%) 30 mL once
DRUGPlacebo
ESP with matching saline placebo
OTHERMonitored Anesthesia Care
Standard monitored anesthesia care
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Triple blind study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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.). |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed