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The purpose of the study is to evaluate whether being randomized to an aggressive postoperative non-narcotic pain regimen that treats pain from multiple different pathways may decrease postoperative pain levels, decrease constipation, and decrease the dependency on opioid medications after anorectal surgery versus the standard of care for managing pain. This use of a more aggressive pain regimen is considered an enhanced recovery after surgery (ERAS) protocol because it is theorized to improve or "enhance" postoperative recovery by both decreasing the use of narcotics and their detrimental effects as well as increasing the benefit of using additional non-narcotic pain medication.
Although pain is a predictable part of the postoperative experience, inadequate management of pain is common and can have profound implications Most patients who undergo surgical procedures experience acute postoperative pain, but evidence suggests that less than half report adequate postoperative pain relief. Many preoperative, intraoperative, and postoperative interventions and management strategies are available for reducing and managing postoperative pain. Mostly, pain is treated with opioids which are narcotics. medically they are primarily used for pain relief and these are historically considered "safe" drugs as they do not impose an increased risk of bleeding, kidney, or stomach problems. However, many patients taking high dose opioids have a higher risk of constipation. Unrelieved postoperative pain may result in economic and medical implications such as extended lengths of stay, readmissions, and patient dissatisfaction with medical care. With the rising concern over narcotic use, physicians are increasingly seeking alternative ways to help patients manage pain throughout their hospital stay and beyond However, few studies in anorectal surgery have shown that using an aggressive postoperative non-narcotic pain regimen (ERAS) can help reduce postoperative pain and decreased returns to emergency care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (multimodal ERAS) | Experimental | Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control:
Postoperative laxative regimen:
|
|
| Arm 2 (control) | Active Comparator | Postoperative pain control:
Postoperative laxative regimen:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERAS | Combination Product | Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Narcotic Use Postoperatively in Oral Morphine Equivalents | Total amount of narcotics used | 1 week postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Median Postoperative Pain Scores | Level of pain measured on a scale of 0-10 with 0 being the lowest level of pain and 10 being the highest level of pain as reported by the participant | 1 week postoperatively |
| Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Zaghiyan, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai | Los Angeles | California | 90048 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39016381 | Derived | Yao LY, Parrish AB, Fleshner PR, Zaghiyan KN. Implementation of a Multimodal Enhanced Recovery Protocol in Ambulatory Anorectal Surgery: A Randomized Trial. Dis Colon Rectum. 2024 Oct 1;67(10):1304-1312. doi: 10.1097/DCR.0000000000003435. Epub 2024 Jul 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 (Multimodal ERAS) | Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control:
Postoperative laxative regimen:
ERAS: Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol |
| FG001 | Arm 2 (Control) | Postoperative pain control:
Postoperative laxative regimen:
Standard of care: Oxcodone PO Ketorolac IV only (intraop) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 (Multimodal ERAS) | Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control:
Postoperative laxative regimen:
ERAS: Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Total Narcotic Use Postoperatively in Oral Morphine Equivalents | Total amount of narcotics used | Posted | Median | Full Range | Oral morphine miligram equivalents | 1 week postoperatively |
|
30 days postoperatively
Any unexpected or adverse event that may or may not have resulted in unplanned visit to the emergency department, clinic, or additional tests or procedures.
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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 | Arm 1 (Multimodal ERAS) | Arm1 (Multimodal ERAS): Preoperative: oral gabapentin 600mg and oral acetaminophen 1,000mg Postoperative pain control:
Postoperative laxative regimen:
ERAS: Gabapentin Acetaminophen Ketoroloac IV (intraop) and PO Dexamethasone (included with benzocaine in local anesthesia) Oxycodone PO Polyethylene glycol |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse event not resulting in significant morbidity or mortality | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Zaghiyan | Cedars-Sinai Medical Center | 310-289-9224 | karen.zaghiyan@cshs.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 | Feb 3, 2020 | Sep 4, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 6, 2020 | Sep 4, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Combination Product | Oxcodone PO Ketorolac IV only (intraop) |
|
Number of participants who experienced complications
| 1 month postoperatively |
| BG001 | Arm 2 (Control) | Postoperative pain control:
Postoperative laxative regimen:
Standard of care: Oxcodone PO Ketorolac IV only (intraop) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Arm 2 (Control) | Postoperative pain control:
Postoperative laxative regimen:
Standard of care: Oxcodone PO Ketorolac IV only (intraop) |
|
|
| Secondary | Median Postoperative Pain Scores | Level of pain measured on a scale of 0-10 with 0 being the lowest level of pain and 10 being the highest level of pain as reported by the participant | Posted | Median | Full Range | score on a scale | 1 week postoperatively |
|
|
|
| Secondary | Complications | Number of participants who experienced complications | Posted | Count of Participants | Participants | 1 month postoperatively |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 4 |
| 45 |
| EG001 | Arm 2 (Control) | Postoperative pain control:
Postoperative laxative regimen:
Standard of care: Oxcodone PO Ketorolac IV only (intraop) | 0 | 44 | 0 | 44 | 2 | 44 |
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