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low enrollment
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The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain relief than both bupivacaine hcl and the control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel | Active Comparator | 266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL) |
|
| Bupivacaine HCl with epinephrine | Active Comparator | 75mg/30mL 0.25% Bupivacaine HCl with epinephrine |
|
| Normal Saline | Placebo Comparator | 30mL Normal Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | 266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative Pain Control | The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain. | up to 4 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Oxycodone Tablets Taken | Number of postoperative opioid consumption - oxycodone tablets (5mg each) | up to 4 days |
| Postoperative Opioid Consumption - Hydromorphone I.V | 1 hour and 2 hours post op |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ali Shariat, MD | St. Luke's-Roosevelt Hospital Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St.Luke's-Roosevelt Hospital Center | New York | New York | 10027 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exparel | 266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL) |
| FG001 | Bupivacaine HCl With Epinephrine | 75mg/30mL 0.25% Bupivacaine HCl with epinephrine |
| FG002 | Normal Saline | 30mL Normal Saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exparel | 266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL) |
| BG001 | Bupivacaine HCl With Epinephrine | 75mg/30mL 0.25% Bupivacaine HCl with epinephrine |
| 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 | Post Operative Pain Control | The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain. | Posted | Mean | Full Range | score on a scale | up to 4 days |
|
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There were no adverse events
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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 | Exparel | 266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ali Shariat | Mount Sinai St. Luke's | 914-409-5023 | alishariatmd@gmail.com |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine HCl with Epinephrine | Drug | 75mg/30mL 0.25% Bupivacaine HCl with epinephrine |
|
| Normal Saline | Drug | 30mL Normal Saline |
|
| Number of Participants With Postoperative Nausea and Vomiting | Number of participants with postoperative nausea and vomiting episodes | up to 4 days |
| Number of Participants With Pain During Bowel Movements | Number of participants with pain during postoperative bowel movements | Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days |
| Number of Participants With Urinary Retention | up to 4 days |
| BG002 | Normal Saline | 30mL Normal Saline |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Normal Saline |
30mL Normal Saline |
|
|
| Secondary | Number of Oxycodone Tablets Taken | Number of postoperative opioid consumption - oxycodone tablets (5mg each) | Posted | Mean | Standard Deviation | tablets | up to 4 days |
|
|
|
| Secondary | Postoperative Opioid Consumption - Hydromorphone I.V | Posted | Mean | Standard Deviation | mg | 1 hour and 2 hours post op |
|
|
|
| Secondary | Number of Participants With Postoperative Nausea and Vomiting | Number of participants with postoperative nausea and vomiting episodes | Posted | Count of Participants | Participants | up to 4 days |
|
|
|
| Secondary | Number of Participants With Pain During Bowel Movements | Number of participants with pain during postoperative bowel movements | Posted | Count of Participants | Participants | Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days |
|
|
|
| Secondary | Number of Participants With Urinary Retention | Posted | Count of Participants | Participants | up to 4 days |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Bupivacaine HCl With Epinephrine | 75mg/30mL 0.25% Bupivacaine HCl with epinephrine | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Normal Saline | 30mL Normal Saline | 0 | 2 | 0 | 2 | 0 | 2 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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