Postoperative Pain
Conditions
Brief summary
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.
Interventions
DRUGPreoperative 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.
DRUGPreoperative 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.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women \> 18 years old * English-speaking * Stage \> 2 pelvic organ prolapse * Undergoing pelvic organ prolapse procedure (including native tissue vaginal procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic procedure, obliterative procedure) * Planning overnight stay
Exclusion criteria
* Renal dysfunction (creatinine clearance \<60 mL/min) * Allergy to acetaminophen and ibuprofen * Allergy to gabapentin * Patients on a Controlled Substance Agreement or Opioid Contract from another provider. This information is available in the IU Health electronic medical record, Cerner.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Prescription at Discharge | Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inpatient Pain Scores | Length of postoperative hospital stay (an average of 32 hours following surgery) | 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. |
| Inpatient Morphine Milligram Equivalents | Length of postoperative hospital stay (an average of 32 hours following surgery) | 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. |
| Opioid Refill Requests | 6 weeks | 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. |
| Nausea | Length of postoperative hospital stay (an average of 32 hours following surgery) | Nausea will be measured by the number of as needed antiemetics the patient received postoperatively. |
| Sedation | On postoperative day 1 between 6AM and 10AM | 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. |
| Length of Stay | Time of registration for surgery to time of discharge from hospital | Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 59 |
| 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. | 55 |
| Total | 114 |
Baseline characteristics
| Characteristic | Preoperative Gabapentin/Postoperative Placebo | Preoperative Gabapentin/Postoperative Gabapentin | Total |
|---|---|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 11.1 | 59.8 years STANDARD_DEVIATION 12.9 | 59.6 years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 54 Participants | 49 Participants | 103 Participants |
| Sex: Female, Male Female | 59 Participants | 55 Participants | 114 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 55 |
| other Total, other adverse events | 0 / 59 | 0 / 55 |
| serious Total, serious adverse events | 0 / 59 | 0 / 55 |
Outcome results
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.
Time frame: Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Preoperative Gabapentin/Postoperative Placebo | Opioid Prescription at Discharge | Opioid prescription at discharge | 40 Participants |
| Preoperative Gabapentin/Postoperative Placebo | Opioid Prescription at Discharge | No opioid prescription at discharge | 19 Participants |
| Preoperative Gabapentin/Postoperative Gabapentin | Opioid Prescription at Discharge | Opioid prescription at discharge | 40 Participants |
| Preoperative Gabapentin/Postoperative Gabapentin | Opioid Prescription at Discharge | No opioid prescription at discharge | 15 Participants |
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.
Time frame: Length of postoperative hospital stay (an average of 32 hours following surgery)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Gabapentin/Postoperative Placebo | Inpatient Morphine Milligram Equivalents | 15 morphine milligram equivalenst |
| Preoperative Gabapentin/Postoperative Gabapentin | Inpatient Morphine Milligram Equivalents | 7.5 morphine milligram equivalenst |
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.
Time frame: Length of postoperative hospital stay (an average of 32 hours following surgery)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Gabapentin/Postoperative Placebo | Inpatient Pain Scores | 6 units on a scale |
| Preoperative Gabapentin/Postoperative Gabapentin | Inpatient Pain Scores | 7 units on a scale |
Secondary
Length of Stay
Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital.
Time frame: Time of registration for surgery to time of discharge from hospital
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Preoperative Gabapentin/Postoperative Placebo | Length of Stay | 32.8 hours | Standard Deviation 7.6 |
| Preoperative Gabapentin/Postoperative Gabapentin | Length of Stay | 31.0 hours | Standard Deviation 4.3 |
Secondary
Nausea
Nausea will be measured by the number of as needed antiemetics the patient received postoperatively.
Time frame: Length of postoperative hospital stay (an average of 32 hours following surgery)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Preoperative Gabapentin/Postoperative Placebo | Nausea | 0 antiemetics used |
| Preoperative Gabapentin/Postoperative Gabapentin | Nausea | 0 antiemetics used |
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.
Time frame: 6 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Preoperative Gabapentin/Postoperative Placebo | Opioid Refill Requests | Refill/new opioid prescription within 6 weeks | 50 Participants |
| Preoperative Gabapentin/Postoperative Placebo | Opioid Refill Requests | No refill/new opioid prescription within 6 weeks | 9 Participants |
| Preoperative Gabapentin/Postoperative Gabapentin | Opioid Refill Requests | Refill/new opioid prescription within 6 weeks | 49 Participants |
| Preoperative Gabapentin/Postoperative Gabapentin | Opioid Refill Requests | No refill/new opioid prescription within 6 weeks | 6 Participants |
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.
Time frame: On postoperative day 1 between 6AM and 10AM
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Preoperative Gabapentin/Postoperative Placebo | Sedation | Feeling active, vital, alert, or wide awake | 13 Participants |
| Preoperative Gabapentin/Postoperative Placebo | Sedation | Foggy; losing interest in remaining awake; slowed down | 2 Participants |
| Preoperative Gabapentin/Postoperative Placebo | Sedation | Functioning at high levels, but not at peak; able to concentrate | 19 Participants |
| Preoperative Gabapentin/Postoperative Placebo | Sedation | Sleep, woozy, fighting sleep; prefer to lie down | 1 Participants |
| Preoperative Gabapentin/Postoperative Placebo | Sedation | Somewhat foggy, let down | 5 Participants |
| Preoperative Gabapentin/Postoperative Placebo | Sedation | No longer fight sleep, sleep onset soon, having dream-like thoughts | 0 Participants |
| Preoperative Gabapentin/Postoperative Placebo | Sedation | Awake, but relaxed; responsive but not fully alert | 8 Participants |
| Preoperative Gabapentin/Postoperative Gabapentin | Sedation | No longer fight sleep, sleep onset soon, having dream-like thoughts | 0 Participants |
| Preoperative Gabapentin/Postoperative Gabapentin | Sedation | Feeling active, vital, alert, or wide awake | 15 Participants |
| Preoperative Gabapentin/Postoperative Gabapentin | Sedation | Functioning at high levels, but not at peak; able to concentrate | 15 Participants |
| Preoperative Gabapentin/Postoperative Gabapentin | Sedation | Awake, but relaxed; responsive but not fully alert | 12 Participants |
| Preoperative Gabapentin/Postoperative Gabapentin | Sedation | Somewhat foggy, let down | 3 Participants |
| Preoperative Gabapentin/Postoperative Gabapentin | Sedation | Foggy; losing interest in remaining awake; slowed down | 1 Participants |
| Preoperative Gabapentin/Postoperative Gabapentin | Sedation | Sleep, woozy, fighting sleep; prefer to lie down | 4 Participants |