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Met futility threshold at interim analysis
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This study aims to evaluate the utility of long-acting liposomal bupivacaine (Exparel®) in improving pain scores and reducing narcotic pain requirements in pediatric patients following minor urologic procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine plus 0.25% Bupivacaine | Experimental | Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine |
|
| 0.25% Bupivacaine alone | Active Comparator | Participants will receive local wound infiltration with 0.25% Bupivacaine alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel 133 miligrams per 10 milliliter injection | Drug | Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Are Opiate-free | Percentage of patients who are opiate-free at 48 hours postoperatively. | 48 hours postoperatively |
| Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively | Percentage of patients who are opiate-free at 10-14 days postoperatively. | 10-14 days postoperatively |
| Parents' Postoperative Pain Measure (PPPM) Scores | 15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain. | 48 hours postoperatively |
| Parents' Postoperative Pain Measure (PPPM) Scores | 15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain. | 10-14 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of Opioid Medication Used Post-discharge | Weight based amount of opioid medication (in OMEQ/kg) used post-discharge. | 10-14 days postoperatively |
| Percentage of Patients With Leftover Opioid Medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather N DiCarlo, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37871332 | Derived | Gabrielson AT, Galansky L, Sholklapper T, Crigger C, Patel HD, Harris K, Haney N, Jing Y, Wang MH, Wu C, Gearhart JP, Di Carlo HN. Effectiveness of Liposomal Bupivacaine With Bupivacaine Hydrochloride vs Bupivacaine Hydrochloride Alone as a Local Anesthetic for Children Undergoing Ambulatory Urologic Surgery: The Baby ORIOLES Randomized Clinical Trial. J Urol. 2024 Jan;211(1):37-47. doi: 10.1097/JU.0000000000003764. Epub 2023 Oct 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine Plus 0.25% Bupivacaine | Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 1, 2021 |
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| Bupivacaine Hydrochloride | Drug | Local wound infiltration with 0.25% bupivacaine. |
|
Percentage of patients with leftover opioid medication
| 10-14 days postoperatively |
| Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity | Cumulative incidence of complications related to local anesthetic systemic toxicity | 10-14 days postoperatively |
| FG001 |
| 0.25% Bupivacaine Alone |
Participants will receive local wound infiltration with 0.25% Bupivacaine alone. Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine Plus 0.25% Bupivacaine | Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine. |
| BG001 | 0.25% Bupivacaine Alone | Participants will receive local wound infiltration with 0.25% Bupivacaine alone. Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
| |||||||||||||||
| Procedure Type | Count of Participants | Participants |
| ||||||||||||||||
| Postoperative Pain Management Strategies | Number | participants |
| ||||||||||||||||
| Surgeon Performing Procedure | Count of Participants | Participants |
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| 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 | Percentage of Patients Who Are Opiate-free | Percentage of patients who are opiate-free at 48 hours postoperatively. | Posted | Number | percentage of patients opioid-free | 48 hours postoperatively |
|
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| ||||||||||||||||||||||||||||||
| Primary | Percentage of Patients Who Are Opiate-free at 10-14 Days Postoperatively | Percentage of patients who are opiate-free at 10-14 days postoperatively. | Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis) | Posted | Number | percentage of pt opioid-free at 10-14d | 10-14 days postoperatively |
|
| ||||||||||||||||||||||||||||||
| Primary | Parents' Postoperative Pain Measure (PPPM) Scores | 15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain. | Posted | Median | Inter-Quartile Range | score on a scale | 48 hours postoperatively |
|
| ||||||||||||||||||||||||||||||
| Primary | Parents' Postoperative Pain Measure (PPPM) Scores | 15-item, yes/no behavioral checklist based on non-verbal pain cues children show following surgery. Scale is from 0 to 15, with higher scores denoting more severe pain. A score of 6+ has been validated as a threshold for a child experiencing clinically significant pain. | Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis) | Posted | Median | Inter-Quartile Range | score on a scale | 10-14 days postoperatively |
|
| |||||||||||||||||||||||||||||
| Secondary | Amount of Opioid Medication Used Post-discharge | Weight based amount of opioid medication (in OMEQ/kg) used post-discharge. | Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis) | Posted | Median | Inter-Quartile Range | Oral morphine equivalent per kg (OMEQ/kg | 10-14 days postoperatively |
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| |||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Leftover Opioid Medication | Percentage of patients with leftover opioid medication | Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis) | Posted | Number | % of patients with leftover opiates | 10-14 days postoperatively |
|
| ||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Complications Related to Local Anesthetic Systemic Toxicity | Cumulative incidence of complications related to local anesthetic systemic toxicity | Two patients in the intervention arm were lost to follow-up at the 10-14d followup (thus 50 were available for analysis) | Posted | Count of Participants | Participants | 10-14 days postoperatively |
|
|
1 month
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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 | Liposomal Bupivacaine Plus 0.25% Bupivacaine | Participants will receive local wound infiltration with sequential Liposomal Bupivacaine plus 0.25% Bupivacaine Exparel 133 miligrams per 10 milliliter injection: Local wound infiltration with Exparel 133 miligrams per 10 milliliter injection Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine. | 0 | 52 | 0 | 52 | 7 | 52 |
| EG001 | 0.25% Bupivacaine Alone | Participants will receive local wound infiltration with 0.25% Bupivacaine alone. Bupivacaine Hydrochloride: Local wound infiltration with 0.25% bupivacaine. | 0 | 52 | 0 | 52 | 5 | 52 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative swelling | Renal and urinary disorders | Non-systematic Assessment | Postoperative swelling prompting a phone call/message to the office |
| |
| Penile Hematoma | Renal and urinary disorders | Non-systematic Assessment | Hematoma |
|
The trial met the predetermined threshold for early stopping.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew T. Gabrielson, MD | Johns Hopkins University School of Medicine | 410-955-5000 | atg@jhmi.edu |
| Dec 4, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D007021 | Hypospadias |
| D003456 | Cryptorchidism |
| D006848 | Testicular Hydrocele |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014564 | Urogenital Abnormalities |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D013733 | Testicular Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
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| African American |
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| Asian |
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| LatinX/Hispanic |
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| Circumcision |
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| Distal Hypospadias Repair |
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| Inguinal Hernia Repair/Hydrocelectomy |
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| Penile Cyst Excision |
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| Chordee Repair |
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| Tylenol |
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| Ibuprofen plus Tylenol |
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| Surgeon 2 |
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| Surgeon 3 |
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| Surgeon 4 |
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| Participants |
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