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PI left institution and unable to find new PI
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Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. The site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon.
Serratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores.
The lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. It can be safely performed under ultrasound guidance.
The purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.
Participants will be assigned randomly using a computer-generated table of numbers to either serratus group or infiltration group. Block team will perform all blocks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serratus Plane Group | Active Comparator | Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound. |
|
| Placebo Group | Placebo Comparator | Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | 20 cc 0.5% |
| |
| Bupivacaine liposome |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Opioid Consumption | The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure. | up to 24 hours post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Dose of Narcotic Administration | Time to first dose of narcotic administration post procedure | up to 24 hours post procedure |
| PACU Length of Stay | The length of stay post procedure in the PACU |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan Lai, MD, MPH | cahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai St. Luke's Hospital | New York | New York | 10019 | United States | ||
| Mount Sinai West Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27543533 | Background | Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223. | |
| 21831090 | Background | Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Serratus Plane Group | Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound. |
| FG001 | Placebo Group | Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Serratus Plane Group | Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound. |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Amount of Opioid Consumption | The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure. | Posted | Mean | Standard Deviation | MME | up to 24 hours post procedure |
|
2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Serratus Plane Group | Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Poonam Pai | Icahn School of Medicine at Mount Sinai | 347-569-4816 | poonam.paibantwalhebbalasankatte@mountsinai.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 8, 2017 | Aug 3, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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The patient, surgeon, and anesthesiologist in the case will be blinded.
| Drug |
133mg liposomal bupivacaine |
|
| average 3-4 hours post procedure |
| ICU Length of Stay | The length of stay post procedure in the or ICU | up to 40 hours post procedure |
| Visual Analogue Score (VAS) | Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain) | up to 24 hours post procedure |
| Patient Satisfaction Score | Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied) | up to 24 hours post procedure |
| New York |
| New York |
| 10019 |
| United States |
| Background | Thoracic paravertebral block versus pectoral nerve block for analgesia after breast surgery. Egypt J Anaesth. 2013; 30: 129-135. Wahba, SS and Kamal, SM. |
Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | missing data | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Secondary | Time to First Dose of Narcotic Administration | Time to first dose of narcotic administration post procedure | Posted | Mean | Standard Deviation | hours | up to 24 hours post procedure |
|
|
|
| Secondary | PACU Length of Stay | The length of stay post procedure in the PACU | Posted | Mean | Standard Deviation | hours | average 3-4 hours post procedure |
|
|
|
| Secondary | ICU Length of Stay | The length of stay post procedure in the or ICU | only those participants who required an ICU stay | Posted | Mean | Standard Deviation | hours | up to 40 hours post procedure |
|
|
|
| Secondary | Visual Analogue Score (VAS) | Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain) | Posted | Mean | Standard Deviation | score on a scale | up to 24 hours post procedure |
|
|
|
| Secondary | Patient Satisfaction Score | Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied) | Data not collected | Posted | up to 24 hours post procedure |
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Placebo Group | Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000588 |
| Amines |
| at 6 hours |
|
| at 18 hours |
|
| at 24 hours |
|