Pain Control
Conditions
Keywords
Gabapentin Abortion
Brief summary
Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion.
Detailed description
A double-blind placebo controlled trial of gabapentin in the setting of an ambulatory surgical abortion center where patients receive either the routine intravenous sedation, local cervical anesthesia plus 600mg of gabapentin one hour prior to surgery vs. the same regimen plus placebo one hour prior to surgery. Our primary outcome measure will be post-operative validated pain scores using a 11-point visual analog scale (VAS). Secondary measures will include nausea and vomiting during, after and 24 hours after the procedure. A second and third pain assessment using VAS will be made at 30 minutes and at 24 hours postoperatively.
Interventions
DRUGGabapentin
Preoperative treatment with Gabapentin
DRUGPlacebos
Preoperative treatment with Placebo
Sponsors
University of Nevada, Las Vegas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
pharmacy prepared sequentially numbered opaque bottles with identical capsules containing either placebo (vit c) or Gabapentin 600mg, block randomized
Intervention model description
double-blind placebo-controlled randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women seeking surgical abortion between 5 and 23 6/7 weeks of ultrasound age. * English or Spanish speaking * eligible for office-based surgical pregnancy termination
Exclusion criteria
* present use of gabapentin or pregabalin, * renal disease * sensitivity or allergy to gabapentin * Missed abortion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score | 5 minutes postoperative | 100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score 24 | 24 hours postop | Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain |
| Nausea | 24 hours postoperative | Nausea at 24 hours using 100mm VAS, 1=none, 100=extreme |
| Vomiting | 24 hours postoperative | Vomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme |
| Pain Score at 30 Minutes Postoperative | 30 minutes postoperative | 100mm Visual analog scale for level of pain, 1-100, 1=no pain, 100= extreme pain |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin Arm Gabapentin 600 mg given 1-2 hours prior to surgical abortion
Gabapentin: Preoperative treatment with Gabapentin | 107 |
| Placebo Arm Placebo (vit C) given 1-2 hours prior to surgical abortion
Placebos: Preoperative treatment with Placebo | 109 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Delivered prior to procedure | 0 | 1 |
| Overall Study | Pharmacy error | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo Arm | Total | Gabapentin Arm |
|---|---|---|---|
| Age, Continuous | 27.1 years STANDARD_DEVIATION 6.03 | 27.4 years STANDARD_DEVIATION 6.13 | 27.7 years STANDARD_DEVIATION 6.26 |
| Living Arrangements Alone | 10 Participants | 23 Participants | 13 Participants |
| Living Arrangements with Children | 44 Participants | 72 Participants | 28 Participants |
| Living Arrangements with Family | 35 Participants | 72 Participants | 37 Participants |
| Living Arrangements with Friends | 7 Participants | 14 Participants | 7 Participants |
| Living Arrangements with Partner | 46 Participants | 90 Participants | 44 Participants |
| Pregnancy History History of Abortions | 47 Participants | 98 Participants | 51 Participants |
| Pregnancy History History of cesarean delivery | 23 Participants | 41 Participants | 18 Participants |
| Pregnancy History history of ectopic pregnancy | 5 Participants | 5 Participants | 0 Participants |
| Pregnancy History History of Miscarriages | 20 Participants | 43 Participants | 23 Participants |
| Pregnancy History History of Stillbirths | 4 Participants | 4 Participants | 0 Participants |
| Pregnancy History History of Surgical Abortion | 44 Participants | 90 Participants | 46 Participants |
| Pregnancy History History of Vaginal deliveries | 59 Participants | 99 Participants | 40 Participants |
| Pregnancy History Previous Pregnancy YES | 88 Participants | 170 Participants | 82 Participants |
| Race/Ethnicity, Customized Asian | 5 Participants | 11 Participants | 6 Participants |
| Race/Ethnicity, Customized Black/ African American | 18 Participants | 38 Participants | 20 Participants |
| Race/Ethnicity, Customized Hawiian/Pacific Islander | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 47 Participants | 83 Participants | 36 Participants |
| Race/Ethnicity, Customized more than one | 10 Participants | 13 Participants | 3 Participants |
| Race/Ethnicity, Customized other | 33 Participants | 50 Participants | 17 Participants |
| Race/Ethnicity, Customized White/Caucasian | 39 Participants | 92 Participants | 53 Participants |
| Region of Enrollment United States | 109 participants | 216 participants | 107 participants |
| Sex: Female, Male Female | 109 Participants | 216 Participants | 107 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 / 107 | 0 / 109 |
| other Total, other adverse events | 0 / 107 | 0 / 109 |
| serious Total, serious adverse events | 0 / 107 | 0 / 109 |
Outcome results
Primary
Pain Score
100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain
Time frame: 5 minutes postoperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin Arm | Pain Score | 17 score on a scale |
| Placebo Arm | Pain Score | 17 score on a scale |
Secondary
Nausea
Nausea at 24 hours using 100mm VAS, 1=none, 100=extreme
Time frame: 24 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin Arm | Nausea | 1.74 VAS 100mm | Standard Deviation 10.923 |
| Placebo Arm | Nausea | 1.74 VAS 100mm | Standard Deviation 8.14 |
Secondary
Pain Score 24
Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain
Time frame: 24 hours postop
Population: We lost to followup 40 in Gaba arm, 48 in the placebo arm at 24 hrs - these patients did not respond to our calls
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin Arm | Pain Score 24 | 0 score on a scale |
| Placebo Arm | Pain Score 24 | 1 score on a scale |
Secondary
Pain Score at 30 Minutes Postoperative
100mm Visual analog scale for level of pain, 1-100, 1=no pain, 100= extreme pain
Time frame: 30 minutes postoperative
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin Arm | Pain Score at 30 Minutes Postoperative | 20 score on a scale |
| Placebo Arm | Pain Score at 30 Minutes Postoperative | 23 score on a scale |
Secondary
Vomiting
Vomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme
Time frame: 24 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin Arm | Vomiting | 0.85 VAS 100mm | Standard Deviation 6.063 |
| Placebo Arm | Vomiting | 0.74 VAS 100mm | Standard Deviation 5.125 |