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The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Gabapentin/Postoperative Placebo | Placebo Comparator |
| |
| Preoperative Gabapentin/Postoperative Gabapentin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Gabapentin/Postoperative Placebo | Drug | Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Prescription at Discharge | Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids. | Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Refill Requests | Number of patients in each group who call the office to request a new opioid prescription (if they were discharged without a prescription) or to request an opioid prescription refill (if they were discharged with a prescription) within the 6-week postoperative time period. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglass S Hale, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42294807 | Derived | Guanzon A, Hale D, Morse D, Bhamidipalli SS, Guise D, Hamner J, Heit M. Perioperative Gabapentin and Opioid Requirements: A Randomized Controlled Trial. Urogynecology (Phila). 2026 Jun 15. doi: 10.1097/SPV.0000000000001891. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Preoperative Gabapentin/Postoperative Placebo | Preoperative Gabapentin/Postoperative Placebo: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain. |
| FG001 | Preoperative Gabapentin/Postoperative Gabapentin | Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Preoperative Gabapentin/Postoperative Placebo | Preoperative Gabapentin/Postoperative Placebo: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain. |
| 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 Prescription at Discharge | Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids. | Posted | Count of Participants | Participants | Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery) |
|
Each participant was assessed from time of surgery until their six week postoperative visit, an average of 6 weeks.
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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 | Preoperative Gabapentin/Postoperative Placebo | Preoperative Gabapentin/Postoperative Placebo: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anna Guanzon | Indiana University School of Medicine | 2197651884 | amguanzon89@gmail.com |
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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 | Mar 23, 2021 | Aug 26, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| Preoperative Gabapentin/Postoperative Gabapentin | Drug | Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain. |
|
| Inpatient Pain Scores |
Pain scores in the hospital will be measured on a numeric rating scale (0-10) with 0 being no pain and 10 being worst pain. Highest pain score recorded. |
| Length of postoperative hospital stay (an average of 32 hours following surgery) |
| Inpatient Morphine Milligram Equivalents | Total morphine milligram equivalents used will be calculated by converting total PO and IV opioids used postoperatively until hospital discharge to morphine milligram equivalents using the opioid equianalgesic chart. | Length of postoperative hospital stay (an average of 32 hours following surgery) |
| Length of Stay | Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital. | Time of registration for surgery to time of discharge from hospital |
| Nausea | Nausea will be measured by the number of "as needed" antiemetics the patient received postoperatively. | Length of postoperative hospital stay (an average of 32 hours following surgery) |
| Sedation | Sedation will be measured by the Stanford Sleepiness Scale. This is a self-administered scale that the patient will complete at 10AM on postoperative day 1. | On postoperative day 1 between 6AM and 10AM |
| BG001 |
| Preoperative Gabapentin/Postoperative Gabapentin |
Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain. |
|
|
| Secondary | Opioid Refill Requests | Number of patients in each group who call the office to request a new opioid prescription (if they were discharged without a prescription) or to request an opioid prescription refill (if they were discharged with a prescription) within the 6-week postoperative time period. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| Secondary | Inpatient Pain Scores | Pain scores in the hospital will be measured on a numeric rating scale (0-10) with 0 being no pain and 10 being worst pain. Highest pain score recorded. | Posted | Median | Full Range | units on a scale | Length of postoperative hospital stay (an average of 32 hours following surgery) |
|
|
|
| Secondary | Inpatient Morphine Milligram Equivalents | Total morphine milligram equivalents used will be calculated by converting total PO and IV opioids used postoperatively until hospital discharge to morphine milligram equivalents using the opioid equianalgesic chart. | Posted | Median | Full Range | morphine milligram equivalenst | Length of postoperative hospital stay (an average of 32 hours following surgery) |
|
|
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| Secondary | Length of Stay | Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital. | Posted | Mean | Standard Deviation | hours | Time of registration for surgery to time of discharge from hospital |
|
|
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| Secondary | Nausea | Nausea will be measured by the number of "as needed" antiemetics the patient received postoperatively. | Posted | Median | Full Range | antiemetics used | Length of postoperative hospital stay (an average of 32 hours following surgery) |
|
|
|
| Secondary | Sedation | Sedation will be measured by the Stanford Sleepiness Scale. This is a self-administered scale that the patient will complete at 10AM on postoperative day 1. | Posted | Count of Participants | Participants | On postoperative day 1 between 6AM and 10AM |
|
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| 0 |
| 59 |
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | Preoperative Gabapentin/Postoperative Gabapentin | Preoperative Gabapentin/Postoperative Gabapentin: Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain. | 0 | 55 | 0 | 55 | 0 | 55 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Awake, but relaxed; responsive but not fully alert |
|
| Somewhat foggy, let down |
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| Foggy; losing interest in remaining awake; slowed down |
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| Sleep, woozy, fighting sleep; prefer to lie down |
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| No longer fight sleep, sleep onset soon, having dream-like thoughts |
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