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This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive 1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control group will receive placebo saline infusions at the same time intervals. All subjects will receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects receiving IV acetaminophen will have lower VAS scores and decreased total narcotic consumption in comparison to the control group.
see brief summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Acetaminophen | Experimental | Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. |
|
| Saline | Placebo Comparator | Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Acetaminophen | Drug | Details covered in arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain While Active - 18 hr | Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active. | 18 hours |
| Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery | Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for nausea/vomiting. | 24 hours |
| Time to First Rescue Narcotic | The time from the end of surgery to the time any IV narcotic is given. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Flatus/Bowel Movement | Length of time from the end of surgery to the time of first flatus or bowel movement. | 9000 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catrina Crisp, MD, MSc | TriHealth Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TriHealth - Good Samaritan and Bethesda North Hospitals | Cincinnati | Ohio | 45220 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28230615 | Derived | Crisp CC, Khan M, Lambers DL, Westermann LB, Mazloomdoost DM, Yeung JJ, Kleeman SD, Pauls RN. The Effect of Intravenous Acetaminophen on Postoperative Pain and Narcotic Consumption After Vaginal Reconstructive Surgery: A Double-Blind Randomized Placebo-Controlled Trial. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):80-85. doi: 10.1097/SPV.0000000000000347. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Acetaminophen | Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description. |
| FG001 | Saline | Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Acetaminophen | Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description. |
| BG001 |
| 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 | Pain While Active - 18 hr | Post operative pain will be assessed 18 hours after surgery. Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable. A pain score will be collected for pain while active. | Posted | Median | Inter-Quartile Range | mm | 18 hours |
|
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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 | IV Acetaminophen | Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Specialist | TriHealth | 513-862-2341 | ganga_devaiah@trihealth.com |
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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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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 24 hours |
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for itching. | 24 hours |
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for headache. | 24 hours |
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for insomnia. | 24 hours |
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for rash/hives. | 24 hours |
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for shortness of breath. | 24 hours |
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for respiratory depression. | 24 hours |
| Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for urinary retention. | 24 hours |
| Time to Ambulation | Length of time from the end of surgery to the time of ambulation. | 1800 minutes |
| Saline |
Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given.
IV Acetaminophen: Details covered in arm description.
|
|
|
| Primary | Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery | Hydromorphone will be administered for breakthrough pain. The total amount consumed in the first 24 hours post surgery will be recorded. | Posted | Median | Inter-Quartile Range | mgs | 24 hours |
|
|
|
| Secondary | Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for nausea/vomiting. | Count reported for nausea/vomiting. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Time to First Rescue Narcotic | The time from the end of surgery to the time any IV narcotic is given. | Posted | Median | Inter-Quartile Range | minutes | 24 hours |
|
|
|
| Secondary | Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for itching. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for headache. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for insomnia. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for rash/hives. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for shortness of breath. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for respiratory depression. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Narcotic Associated Side Effects | The incidence of known narcotic associated side effects will be recorded for urinary retention. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Time to Ambulation | Length of time from the end of surgery to the time of ambulation. | Posted | Median | Inter-Quartile Range | minutes | 1800 minutes |
|
|
|
| Other Pre-specified | Time to First Flatus/Bowel Movement | Length of time from the end of surgery to the time of first flatus or bowel movement. | Posted | Median | Inter-Quartile Range | minutes | 9000 minutes |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Saline | Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours. The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision. A total of 4 doses will be given. IV Acetaminophen: Details covered in arm description. | 0 | 50 | 0 | 50 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |