Not provided
Not provided
Not provided
Not provided
Not provided
interim, lack of obvious benefit
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESP with Bupivacaine Group | Experimental | Erector spinae plane block with bupivacaine. |
|
| ESP with Placebo | Sham Comparator | Erector spinae plane injection with a placebo (normal saline). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine injection | Drug | Erector spinae plane block with bupivacaine (0.5%) 30 mL once |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion criteria:
Exclusion criteria:
Inability to provide informed consent.
Study subject has any disease or condition that interferes with safe completion of the study including:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Udit Chaddha, MBBS | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West Hospital | New York | New York | 10019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40099426 | Derived | Luebbert E, Salguero BD, Joy G, Salman S, Lo Cascio CM, Echevarria G, Chaddha U, Pai B H P. Benefits of Using Peripheral Nerve Blocks for Medical Thoracoscopy: A Retrospective Analysis. J Bronchology Interv Pulmonol. 2025 Mar 18;32(2):e1006. doi: 10.1097/LBR.0000000000001006. eCollection 2025 Apr 1. |
Not provided
Not provided
Data will only be processed by the research team. There is no plan to share IPD and only de-identified data will be collected.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Triple blind study
| Placebo | Drug | ESP with matching saline placebo |
|
| Monitored Anesthesia Care | Other | Standard monitored anesthesia care |
|
| 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.). | 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. | 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. | within the first 24 hours after the intervention |
| 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 |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |