Pelvic Organ Prolapse
Conditions
Keywords
IV acetaminophen, Postoperative pain, Pelvic organ prolapse surgery, Pelvic organ prolapse repair
Brief summary
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.
Detailed description
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.
Interventions
DRUGIV Acetaminophen
DRUGIV normal saline
IV normal saline
Sponsors
Halina M Zyczynski, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women ≥ 18 years of age * scheduled to undergo surgery for POP via a vaginal or minimally invasive (laparoscopic/robotic) route at the University of Pittsburgh Medical Center * women anticipated to have a hospital stay ≥24 hours
Exclusion criteria
* allergy/intolerance to acetaminophen * hepatic dysfunction * significant alcohol use - defined as patient reported consumption of more than 7 standard drinks per week and/or 3 drinks per day
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Postoperative Pain | 24 hours | 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. |
| Cumulative Narcotic Consumption Over the First 24 Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interference of Pain With Physical, Mental and Social Activities | 1 week | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| 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. | 52 |
| 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. | 51 |
| 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. | 50 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Missing critical information | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Laparoscopic Surgery - Placebo | Vaginal Surgery - IV Acetaminophen | Total | Laparoscopic Surgery - IV Acetaminophen | Vaginal Surgery - Placebo |
|---|---|---|---|---|---|
| Age, Continuous | 60.22 years STANDARD_DEVIATION 8 | 70.5 years STANDARD_DEVIATION 9.2 | 65.5 years STANDARD_DEVIATION 9.9 | 62.08 years STANDARD_DEVIATION 7 | 69.24 years STANDARD_DEVIATION 10.87 |
| Baseline POPQ Stage Missing | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Baseline POPQ Stage Stage II | 8 Participants | 7 Participants | 28 Participants | 5 Participants | 8 Participants |
| Baseline POPQ Stage Stage III | 42 Participants | 37 Participants | 151 Participants | 37 Participants | 35 Participants |
| Baseline POPQ Stage Stage IV | 1 Participants | 7 Participants | 21 Participants | 8 Participants | 5 Participants |
| Baseline VAS Pain Score | 5.57 units on a scale STANDARD_DEVIATION 15.6 | 3.41 units on a scale STANDARD_DEVIATION 8.71 | 5.75 units on a scale STANDARD_DEVIATION 13.45 | 6.91 units on a scale STANDARD_DEVIATION 12.75 | 7.32 units on a scale STANDARD_DEVIATION 15.73 |
| Current Smoker | 2 Participants | 2 Participants | 8 Participants | 1 Participants | 3 Participants |
| Parity | 2 births | 2 births | 2 births | 2 births | 2 births |
| Postmenopausal | 44 Participants | 49 Participants | 181 Participants | 45 Participants | 43 Participants |
| Race/Ethnicity, Customized African American | 0 Participants | 2 Participants | 4 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 51 Participants | 50 Participants | 196 Participants | 48 Participants | 47 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 51 Participants | 52 Participants | 202 Participants | 50 Participants | 49 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 52 | 0 / 51 | 0 / 50 |
| other Total, other adverse events | 0 / 49 | 0 / 52 | 0 / 51 | 0 / 50 |
| serious Total, serious adverse events | 1 / 49 | 1 / 52 | 0 / 51 | 3 / 50 |
Outcome results
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.
Time frame: 24 hours
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vaginal Surgery - Placebo | Change From Baseline in Postoperative Pain | 20.5 units on a scale | Standard Deviation 23.1 |
| Vaginal Surgery - IV Acetaminophen | Change From Baseline in Postoperative Pain | 29.2 units on a scale | Standard Deviation 28.3 |
| Laparoscopic Surgery - Placebo | Change From Baseline in Postoperative Pain | 20.7 units on a scale | Standard Deviation 24.6 |
| Laparoscopic Surgery - IV Acetaminophen | Change From Baseline in Postoperative Pain | 20.1 units on a scale | Standard Deviation 25.7 |
Comparison: Aim 1: Quantify the impact of IV acetaminophen on 1a) postoperative pain scores ... 1a) To achieve this aim, we will measure the degree of postoperative pain using visual analog scales (VAS) at multiple specified time points throughout the postoperative period; we report on change from Baseline VAS at 24 Hours Postop. Null Hypothesis is that there is no difference between subgroups in VAS scores. Sample size was determined considering significant differences in VAS scores.p-value: <0.05Mixed Models Analysis
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.
Time frame: First 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vaginal Surgery - Placebo | Cumulative Narcotic Consumption Over the First 24 Hours | 32.5 mg | Standard Deviation 24.7 |
| Vaginal Surgery - IV Acetaminophen | Cumulative Narcotic Consumption Over the First 24 Hours | 31.6 mg | Standard Deviation 23.6 |
| Laparoscopic Surgery - Placebo | Cumulative Narcotic Consumption Over the First 24 Hours | 47.4 mg | Standard Deviation 24.2 |
| Laparoscopic Surgery - IV Acetaminophen | Cumulative Narcotic Consumption Over the First 24 Hours | 44.5 mg | Standard Deviation 24.2 |
Comparison: 1b) We will use equianalgesic dosage tables to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. We hypothesize that those patients receiving preemptive IV acetaminophen will have lower postoperative VAS scores and reduced narcotic requirements compared to placebo.p-value: <0.05t-test, 2 sided
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.
Time frame: 1 week
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vaginal Surgery - Placebo | Interference of Pain With Physical, Mental and Social Activities | 18.4 units on a scale | Standard Deviation 0.15 |
| Vaginal Surgery - IV Acetaminophen | Interference of Pain With Physical, Mental and Social Activities | 22.0 units on a scale | Standard Deviation 11.9 |
| Laparoscopic Surgery - Placebo | Interference of Pain With Physical, Mental and Social Activities | 22.9 units on a scale | Standard Deviation 8.1 |
| Laparoscopic Surgery - IV Acetaminophen | Interference of Pain With Physical, Mental and Social Activities | 25.2 units on a scale | Standard Deviation 9.4 |