Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.
This randomized controlled trial of IV Acetaminophen compared to placebo will evaluate the effect of preoperative IV Acetaminophen on postoperative pain scores and narcotic requirements in women undergoing surgical repair of pelvic organ prolapse. 204 women will randomly receive 1000 mg of IV Acetaminophen or saline preoperatively within 30 minutes of surgical incision. Subjects will be offered narcotic and non-narcotic pain medications as needed during the postoperative period. Visual analogue pain scales (VAS) will be obtained at 4, 8, 12, 16, 20 and 24 hours postoperatively. Narcotic consumption will be recorded in morphine-equivalents. We hypothesize that women receiving IV Acetaminophen will have lower VAS scores and decreased narcotic requirements compared to controls.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. |
|
| IV Acetaminophen | Experimental | 100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Acetaminophen | Drug |
|
| |
| IV normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Postoperative Pain | VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain. For this outcome measure, the VAS scores from Baseline and the VAS scores from 24 hours after the end of surgery are being used. The change from baseline in postoperative pain equals the 24 hour VAS score minus the baseline VAS score. The Change from Baseline would be the 24-hour VAS score minus the Baseline VAS score. Higher values indicate more pain; lower values indicate less pain. | 24 hours |
| Cumulative Narcotic Consumption Over the First 24 Hours | Equianalgesic dosage tables will be used to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. Higher numbers indicate higher narcotic usage. | First 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Interference of Pain With Physical, Mental and Social Activities | Interference of pain with physical, mental and social activities will be measured by the Patient Reported Outcomes Measures Information Systems-Pain Interference-Short Form 8a (PROMIS PI-SF-8a) administered on POD#7. This instrument measures the self reported consequences of pain on relevant aspects of one's life. This scale is considered to be universal rather than disease specific. Each question has five response options ranging in value from 1-5. The total raw score for the scale is the sum of all values. The total raw score can range from 8-40. All questions much be answered to obtain a valid score. A higher PROMIS score indicates more 'hurt' or pain. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital of the University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30741813 | Derived | Turner LC, Zyczynski HM, Shepherd JP. Intravenous Acetaminophen Before Pelvic Organ Prolapse Repair: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):492-502. doi: 10.1097/AOG.0000000000003102. |
Not provided
Not provided
Not provided
Women were recruited form the Urogynecology offices of the University of Pittsburgh Medical Center (UPMC) and Allegheny Health Network (AHN) from July 2014 - August 2017.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vaginal Surgery - Placebo | 100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV normal saline These subjects underwent vaginal surgery. |
| FG001 | Vaginal Surgery - IV Acetaminophen | 100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV Acetaminophen These subjects underwent vaginal surgery. |
| FG002 | Laparoscopic Surgery - Placebo | 100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV normal saline These subjects underwent laparoscopic surgery. |
| FG003 | Laparoscopic Surgery - IV Acetaminophen | 100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV Acetaminophen These subjects underwent laparoscopic surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
One subject in the Vaginal Surgery - Placebo group, and one subject in the Laparoscopic Surgery - IV Acetaminophen group did not complete the study. (Missing critical information: (1) information from the pharmacy regarding group assignment; (2) signed informed consent form.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vaginal Surgery - Placebo | 100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV normal saline These subjects underwent vaginal surgery. |
| BG001 | Vaginal Surgery - IV Acetaminophen |
| 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 | Change From Baseline in Postoperative Pain | VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain. For this outcome measure, the VAS scores from Baseline and the VAS scores from 24 hours after the end of surgery are being used. The change from baseline in postoperative pain equals the 24 hour VAS score minus the baseline VAS score. The Change from Baseline would be the 24-hour VAS score minus the Baseline VAS score. Higher values indicate more pain; lower values indicate less pain. | The number of participants analyzed is less than the total starting the study in each group; data is missing. Missing data indicates that a 24 hour VAS was not obtained from the subject. | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
AEs were collected from day of surgery until 6 weeks postop.
SAEs were defined a priori as readmissions to the hospital for any reason within 6 weeks of surgery. All subject medical records were reviewed to discover these events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vaginal Surgery - Placebo | 100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV normal saline These subjects underwent vaginal surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission within 6 weeks of surgery | Surgical and medical procedures | Systematic Assessment | Any readmission within 6 weeks of surgery. Medical records for all subjects were reviewed to discover these events. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Halina Zyczynski | University of Pittsburgh | 412-641-1440 | hzyczynski@mail.magee.edu |
Not provided
| 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 20, 2018 | Oct 17, 2018 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
IV normal saline |
|
|
| 1 week |
100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV Acetaminophen These subjects underwent vaginal surgery. |
| BG002 | Laparoscopic Surgery - Placebo | 100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV normal saline These subjects underwent laparoscopic surgery. |
| BG003 | Laparoscopic Surgery - IV Acetaminophen | 100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV Acetaminophen These subjects underwent laparoscopic surgery. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Postmenopausal | Count of Participants | Participants |
|
| Current Smoker | Count of Participants | Participants |
|
| Parity | Parity refers to the number of times the subject gave birth to a baby more than 20 weeks gestation. Parity is expressed as a whole number. | Median | Inter-Quartile Range | births |
|
| Baseline POPQ Stage | POP-Q Stage is the Pelvic Organ Prolapse Quantification Stage. This is a whole number which refers to the extend of the prolapse, and how far past the hymen it extends. POP-Q Stage is a whole number between 1 and 4. Stage 1 is prolapse which is fully contained within the vagina and above the hymen. Stage 4 is prolapse which extends at least 3 cm beyond the hymen. | Count of Participants | Participants |
|
| Baseline VAS Pain Score | VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain. | Mean | Standard Deviation | units on a scale |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Vaginal Surgery - Placebo | 100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV normal saline These subjects underwent vaginal surgery. |
| OG001 | Vaginal Surgery - IV Acetaminophen | 100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV Acetaminophen These subjects underwent vaginal surgery. |
| OG002 | Laparoscopic Surgery - Placebo | 100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV normal saline These subjects underwent laparoscopic surgery. |
| OG003 | Laparoscopic Surgery - IV Acetaminophen | 100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV Acetaminophen These subjects underwent laparoscopic surgery. |
|
|
|
| Primary | Cumulative Narcotic Consumption Over the First 24 Hours | Equianalgesic dosage tables will be used to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. Higher numbers indicate higher narcotic usage. | Posted | Mean | Standard Deviation | mg | First 24 hours |
|
|
|
|
| Secondary | Interference of Pain With Physical, Mental and Social Activities | Interference of pain with physical, mental and social activities will be measured by the Patient Reported Outcomes Measures Information Systems-Pain Interference-Short Form 8a (PROMIS PI-SF-8a) administered on POD#7. This instrument measures the self reported consequences of pain on relevant aspects of one's life. This scale is considered to be universal rather than disease specific. Each question has five response options ranging in value from 1-5. The total raw score for the scale is the sum of all values. The total raw score can range from 8-40. All questions much be answered to obtain a valid score. A higher PROMIS score indicates more 'hurt' or pain. | The number of participants analyzed is less than the total starting the study in each group; data is missing. Missing data indicates that the PROMIS PI-SF-8A was not received from the subject. | Posted | Mean | Standard Deviation | units on a scale | 1 week |
|
|
|
| 0 |
| 49 |
| 1 |
| 49 |
| 0 |
| 49 |
| EG001 | Vaginal Surgery - IV Acetaminophen | 100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV Acetaminophen These subjects underwent vaginal surgery. | 0 | 52 | 1 | 52 | 0 | 52 |
| EG002 | Laparoscopic Surgery - Placebo | 100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV normal saline These subjects underwent laparoscopic surgery. | 0 | 51 | 0 | 51 | 0 | 51 |
| EG003 | Laparoscopic Surgery - IV Acetaminophen | 100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery. IV Acetaminophen These subjects underwent laparoscopic surgery. | 0 | 50 | 3 | 50 | 0 | 50 |
|
Not provided
Not provided
Not provided
| D010335 | Pathologic Processes |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |