Pleural DiseasePhase 3NCT06313632
Erector Spinae Plane Block With Bupivacaine for Medical Thoracoscopy
A Phase 3 study testing Bupivacaine injection and Monitored Anesthesia Care in people with Pleural Disease and Postoperative Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleural Disease, Postoperative Pain
- What is being tested?
- Bupivacaine injection and Monitored Anesthesia Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2024to 20 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral for medical thoracoscopy
- Age ≥ 18
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Triple-Blind Randomized Controlled Trial of Erector Spinae Plane Block With Bupivacaine Versus Placebo in Patients Undergoing Medical Thoracoscopy
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.
Read the 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.
- Conditions
- Pleural Disease, Postoperative Pain
- Being tested
- Bupivacaine injection, Placebo, Monitored Anesthesia Care
- Keywords
- Thoracoscopy, Pleuroscopy, Regional Anesthesia, Erector Spinae Plane Block, Pain Control
- Medical subject headings
- Pleural Diseases, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine injectionDrug
Erector spinae plane block with bupivacaine (0.5%) 30 mL once
PlaceboDrug
ESP with matching saline placebo
Monitored Anesthesia CareOther
Standard monitored anesthesia care
| Study group | Role | What they receive |
|---|---|---|
| ESP with Bupivacaine Group | Experimental | Erector spinae plane block with bupivacaine. Receives: Drug: Bupivacaine injection; Other: Monitored Anesthesia Care |
| ESP with Placebo | Sham comparator | Erector spinae plane injection with a placebo (normal saline). Receives: Drug: Placebo; Other: Monitored Anesthesia Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours after the intervention
Secondary outcomes (5)
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.
Measured: 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.).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: within the first 24 hours after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start28 Mar 2024
- Primary completion19 Mar 2025
- Study completion20 Mar 2025
Why it stopped: interim, lack of obvious benefit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pleural DiseaseStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Udit Chaddha, Icahn School of Medicine at Mount Sinai
- Investigators
- Udit Chaddha, MBBS, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313632
- Sponsor's protocol ID
- STUDY-23-01105
- Status last verified
- Apr 2025
- First submitted
- 7 Mar 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will only be processed by the research team. There is no plan to share IPD and only de-identified data will be collected.
Publications
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.
PubMed 40099426
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Triple-Blind Randomized Controlled Trial of Erector Spinae Plane Block With Bupivacaine Versus Placebo in Patients Undergoing Medical Thoracoscopy
- ClinicalTrials.gov ID
- NCT06313632
- Acronym / sponsor ID
- STUDY-23-01105
- Conditions
- Pleural Disease, Postoperative Pain
- Keywords
- Thoracoscopy, Pleuroscopy, Regional Anesthesia, Erector Spinae Plane Block, Pain Control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim, lack of obvious benefit
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP with Bupivacaine Group | Experimental | Drug: Bupivacaine injection, Other: Monitored Anesthesia CareErector spinae plane block with bupivacaine. |
| ESP with Placebo | Sham comparator | Drug: Placebo, Other: Monitored Anesthesia CareErector spinae plane injection with a placebo (normal saline). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Referral for medical thoracoscopy
- Age ≥ 18
Key exclusion criteria (7 listed)
- Inability to provide informed consent.
- Study subject has any disease or condition that interferes with safe completion of the study including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine injectionErector spinae plane block with bupivacaine (0.5%) 30 mL once | Drug | ESP with Bupivacaine Group |
| PlaceboESP with matching saline placebo | Drug | ESP with Placebo |
| Monitored Anesthesia CareStandard monitored anesthesia care | Other | ESP with Bupivacaine Group, ESP with Placebo |
Primary outcome
Visual Analog Scale (VAS) for Pain
Time frame: 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.
5 secondary outcomes
Change in the Numerical Rating Scale
Time frame: At 2 hours post-intervention and 24 hours post-intervention
Type of Analgesic use
Time frame: within the first 24 hours after the intervention
Number of Analgesic use
Time frame: within the first 24 hours after the intervention
Dosage of Analgesic use
Time frame: within the first 24 hours after the intervention
Quality of Recovery-15 (QoR-15) Survey Score
Time frame: within the first 24 hours after the intervention
Results and safety
The study was stopped early (reason given: interim, lack of obvious benefit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Derived from this study: PubMed 40099426Luebbert 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.
- Individual participant dataSharing planned: No. Data will only be processed by the research team. There is no plan to share IPD and only de-identified data will be collected.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Udit Chaddha, MBBS principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine injection and Monitored Anesthesia Care in people with Pleural Disease and Postoperative Pain, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: interim, lack of obvious benefit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) for Pain (time frame: 2 hours after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06313632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.