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A phase IV, randomized, single-blind, single-center study measuring the effects of Pecs II block with 0.25% bupivacaine versus surgeon infiltration with 0.25% bupivacaine on postoperative pain control and opioid utilization in participants who undergo open subpectoral tenodesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pecs II block | Experimental | 80 patients scheduled for open biceps tenodesis |
|
| Surgical infiltration | Active Comparator | 80 patients scheduled for open biceps tenodesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine 20mL 0.5% | Drug | Interscalene nerve block with 20 mL 0.5% bupivacaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Utilization for the First 24 Hours After Surgery | Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery. | Up to 24-Hours Post-Operation |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU) | In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain. | Typically 1-3 Hours Post-Operation |
| Patient-reported Numerical Rating Scale (NRS) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Hertling, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Uchenna.Umeh@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Beginning 9 months and ending 36 months following article publication or as required.
Requests may be directed to Uchenna.Umeh@nyulangone.org.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pecs II Block | 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine. |
| FG001 | Surgical Infiltration | 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pecs II Block | 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine. |
| BG001 | Surgical Infiltration |
| 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 | Opioid Utilization for the First 24 Hours After Surgery | Opioid utilization is calculated as morphine milligram equivalents (MME); measurement includes opioid utilization during surgery. | Posted | Median | Inter-Quartile Range | morphine milligram equivalents | Up to 24-Hours Post-Operation |
|
All events with start dates occurring any time after informed consent is obtained (baseline) until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation, up to 34 days total.
The study coordinator and PI were alerted if participants were admitted to the hospital. If they were admitted during the two week period, the PI determined if it was considered an adverse event related to the study.
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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 | Pecs II Block | 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine 20mL 0.25%: Pecs II fascial plane block with 20 mL 0.25% bupivacaine. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arthur Hertling, MD | NYU Langone Health | 212-598-6085 | arthur.hertling@nyulangone.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 | Dec 4, 2023 | Nov 14, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D013708 | Tendon Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine 20mL 0.25% | Drug | Pecs II fascial plane block with 20 mL 0.25% bupivacaine. |
|
| Bupivacaine up to 15mL 0.25% | Drug | Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL. |
|
In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain. |
| 24 Hours Post-Operation |
| Patient-reported Numerical Rating Scale (NRS) Score | In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain. | Day 3 Post-Operation |
| Number of Patients With Reactions to Surgical Subpectoral Incision - Movement | Number of patients with movement during incision. | Intraoperative |
| Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia | Number of patients with tachycardia during incision. | Intraoperative |
| Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep | Number of patients with sensation in bicep during incision. | Intraoperative |
80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Patient-reported Numerical Rating Scale (NRS) Score in Post Anesthesia Care Unit (PACU) | In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain. | Posted | Median | Inter-Quartile Range | score on a scale | Typically 1-3 Hours Post-Operation |
|
|
|
| Secondary | Patient-reported Numerical Rating Scale (NRS) Score | In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain. | Posted | Median | Inter-Quartile Range | score on a scale | 24 Hours Post-Operation |
|
|
|
| Secondary | Patient-reported Numerical Rating Scale (NRS) Score | In a Numerical Rating Scale (NRS), patients are asked to circle the number between 0 and 10; where 0 = no pain; and 10 = worst pain. | Posted | Median | Inter-Quartile Range | score on a scale | Day 3 Post-Operation |
|
|
|
| Secondary | Number of Patients With Reactions to Surgical Subpectoral Incision - Movement | Number of patients with movement during incision. | Posted | Count of Participants | Participants | Intraoperative |
|
|
|
| Secondary | Number of Patients With Reactions to Surgical Subpectoral Incision - Tachycardia | Number of patients with tachycardia during incision. | Posted | Count of Participants | Participants | Intraoperative |
|
|
|
| Secondary | Number of Patients With Reactions to Surgical Subpectoral Incision - Sensation in Bicep | Number of patients with sensation in bicep during incision. | Posted | Count of Participants | Participants | Intraoperative |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | Surgical Infiltration | 80 patients scheduled for open biceps tenodesis Bupivacaine 20mL 0.5%: Interscalene nerve block with 20 mL 0.5% bupivacaine. Bupivacaine up to 15mL 0.25%: Local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL. | 0 | 80 | 0 | 80 | 0 | 80 |
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| D000588 |
| Amines |