Other Abortion, Spontaneous Abortion
Conditions
Keywords
uterine aspiration
Brief summary
This is a randomized controlled double-blind placebo-controlled trial evaluating the impact of gabapentin given preoperatively on perioperative pain scores for women receiving uterine aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the abortion setting.
Interventions
DRUGGabapentin
600mg Gabapentin administered orally 1-2 hours prior to procedure
DRUGPlacebo
Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women \>=18 years-old * Presenting for a surgical abortion * No contraindication to outpatient abortion * No contraindication to gabapentin * Fluency in English and able to provide informed consent
Exclusion criteria
* Allergy, sensitivity or contraindication to gabapentin * Severe renal disease * Currently using gabapentin or pregalabin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure | 5 minutes | Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative Nausea as Measured by 100-mm VAS | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes | Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life. |
| Number of Subjects Experiencing Perioperative Vomiting | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes | — |
| Perioperative Anxiety as Measured by the 100-mm VAS | 5 minutes, 10 minutes, 30 minutes, discharge | Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious. |
| Number of Subjects Using Pain Medications | 24 hours post-operatively | Pain medications included ibuprofen and oxycodone. |
| Number of Subjects Experiencing Side Effects | 10 minutes post-procedure | Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia. |
| Pain Score on the 100-mm VAS | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute | Measured at baseline, 10 minutes post-procedure, and 30 minutes post-procedure. Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life. |
| Nausea (on a 5-point Scale) | Post-operative day 1 | — |
| Vomiting (on a 5-point Scale) | Post-operative day 1 | — |
| Side Effects (on a 5-point Scale) | Post-operative day 1 | — |
| General Satisfaction With the Procedure (on a 5-point Scale) | Post-operative day 1 | — |
| Pain (on a 5-point Scale) | Post-operative day 1 | — |
Countries
United States
Participant flow
Recruitment details
Recruited between August 2016 and June 2018.
Pre-assignment details
One subject randomized to gabapentin withdrew from the procedure.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Placebo Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure | 48 |
| Group 2: Gabapentin Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure | 47 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Group 2: Gabapentin | Total | Group 1: Placebo |
|---|---|---|---|
| Age, Continuous | 31.7 years STANDARD_DEVIATION 6.1 | 31.7 years STANDARD_DEVIATION 6.1 | 31.8 years STANDARD_DEVIATION 6.3 |
| Baseline Pain | 3.0 units on a scale | 3.0 units on a scale | 3.3 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 87 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 31 Participants | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 26 Participants | 53 Participants | 27 Participants |
| Region of Enrollment United States | 47 participants | 95 participants | 48 participants |
| Sex: Female, Male Female | 47 Participants | 95 Participants | 48 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 / 48 | 0 / 47 |
| other Total, other adverse events | 40 / 48 | 43 / 47 |
| serious Total, serious adverse events | 0 / 48 | 0 / 47 |
Outcome results
Primary
Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure
Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.
Time frame: 5 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Placebo | Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure | 35.7 score on a scale | Standard Deviation 27.5 |
| Group 2: Gabapentin | Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure | 37.1 score on a scale | Standard Deviation 30.4 |
p-value: 0.56Regression, Linear
Secondary
General Satisfaction With the Procedure (on a 5-point Scale)
Time frame: Post-operative day 1
Population: Data not collected.
Secondary
Nausea (on a 5-point Scale)
Time frame: Post-operative day 1
Population: Data not collected.
Secondary
Number of Subjects Experiencing Perioperative Vomiting
Time frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Placebo | Number of Subjects Experiencing Perioperative Vomiting | Baseline | 1 Participants |
| Group 1: Placebo | Number of Subjects Experiencing Perioperative Vomiting | 10 minutes | 1 Participants |
| Group 1: Placebo | Number of Subjects Experiencing Perioperative Vomiting | 30 minutes | 1 Participants |
| Group 2: Gabapentin | Number of Subjects Experiencing Perioperative Vomiting | Baseline | 0 Participants |
| Group 2: Gabapentin | Number of Subjects Experiencing Perioperative Vomiting | 10 minutes | 2 Participants |
| Group 2: Gabapentin | Number of Subjects Experiencing Perioperative Vomiting | 30 minutes | 5 Participants |
Secondary
Number of Subjects Experiencing Side Effects
Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia.
Time frame: 10 minutes post-procedure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Placebo | Number of Subjects Experiencing Side Effects | Dizziness | 14 Participants |
| Group 1: Placebo | Number of Subjects Experiencing Side Effects | Ataxia | 8 Participants |
| Group 1: Placebo | Number of Subjects Experiencing Side Effects | Somnolence | 37 Participants |
| Group 1: Placebo | Number of Subjects Experiencing Side Effects | Asthenia | 31 Participants |
| Group 1: Placebo | Number of Subjects Experiencing Side Effects | Headache | 5 Participants |
| Group 1: Placebo | Number of Subjects Experiencing Side Effects | Amblyopia | 3 Participants |
| Group 2: Gabapentin | Number of Subjects Experiencing Side Effects | Headache | 5 Participants |
| Group 2: Gabapentin | Number of Subjects Experiencing Side Effects | Dizziness | 20 Participants |
| Group 2: Gabapentin | Number of Subjects Experiencing Side Effects | Asthenia | 27 Participants |
| Group 2: Gabapentin | Number of Subjects Experiencing Side Effects | Ataxia | 6 Participants |
| Group 2: Gabapentin | Number of Subjects Experiencing Side Effects | Amblyopia | 3 Participants |
| Group 2: Gabapentin | Number of Subjects Experiencing Side Effects | Somnolence | 41 Participants |
Secondary
Number of Subjects Using Pain Medications
Pain medications included ibuprofen and oxycodone.
Time frame: 24 hours post-operatively
Population: The number of subjects analyzed for ibuprofen and oxycodone and oxycodone only reflects the number of subjects that received a prescription for opiates.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Placebo | Number of Subjects Using Pain Medications | Oxycodone only | 6 Participants |
| Group 1: Placebo | Number of Subjects Using Pain Medications | No pain medication | 10 Participants |
| Group 1: Placebo | Number of Subjects Using Pain Medications | Ibuprofen only | 23 Participants |
| Group 1: Placebo | Number of Subjects Using Pain Medications | Ibuprofen and oxycodone | 9 Participants |
| Group 2: Gabapentin | Number of Subjects Using Pain Medications | Ibuprofen and oxycodone | 6 Participants |
| Group 2: Gabapentin | Number of Subjects Using Pain Medications | Oxycodone only | 1 Participants |
| Group 2: Gabapentin | Number of Subjects Using Pain Medications | Ibuprofen only | 23 Participants |
| Group 2: Gabapentin | Number of Subjects Using Pain Medications | No pain medication | 17 Participants |
Secondary
Pain (on a 5-point Scale)
Time frame: Post-operative day 1
Population: Data not collected.
Secondary
Pain Score on the 100-mm VAS
Measured at baseline, 10 minutes post-procedure, and 30 minutes post-procedure. Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.
Time frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Placebo | Pain Score on the 100-mm VAS | Baseline | 3.3 units on a scale |
| Group 1: Placebo | Pain Score on the 100-mm VAS | 10 minutes | 19.8 units on a scale |
| Group 1: Placebo | Pain Score on the 100-mm VAS | 30 minutes | 12.6 units on a scale |
| Group 2: Gabapentin | Pain Score on the 100-mm VAS | Baseline | 3.0 units on a scale |
| Group 2: Gabapentin | Pain Score on the 100-mm VAS | 10 minutes | 20.0 units on a scale |
| Group 2: Gabapentin | Pain Score on the 100-mm VAS | 30 minutes | 9.5 units on a scale |
Secondary
Perioperative Anxiety as Measured by the 100-mm VAS
Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious.
Time frame: 5 minutes, 10 minutes, 30 minutes, discharge
Population: One subject in the placebo group did not have anxiety at discharge measured.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Placebo | Perioperative Anxiety as Measured by the 100-mm VAS | 5 minutes | 24.5 units on a scale |
| Group 1: Placebo | Perioperative Anxiety as Measured by the 100-mm VAS | 10 minutes | 14.5 units on a scale |
| Group 1: Placebo | Perioperative Anxiety as Measured by the 100-mm VAS | 30 minutes | 13.3 units on a scale |
| Group 1: Placebo | Perioperative Anxiety as Measured by the 100-mm VAS | Discharge | 10.5 units on a scale |
| Group 2: Gabapentin | Perioperative Anxiety as Measured by the 100-mm VAS | Discharge | 8.0 units on a scale |
| Group 2: Gabapentin | Perioperative Anxiety as Measured by the 100-mm VAS | 5 minutes | 23.5 units on a scale |
| Group 2: Gabapentin | Perioperative Anxiety as Measured by the 100-mm VAS | 30 minutes | 7.0 units on a scale |
| Group 2: Gabapentin | Perioperative Anxiety as Measured by the 100-mm VAS | 10 minutes | 11.0 units on a scale |
Secondary
Perioperative Nausea as Measured by 100-mm VAS
Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life.
Time frame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Placebo | Perioperative Nausea as Measured by 100-mm VAS | Baseline | 3.0 units on a scale |
| Group 1: Placebo | Perioperative Nausea as Measured by 100-mm VAS | 10 minutes | 2.5 units on a scale |
| Group 1: Placebo | Perioperative Nausea as Measured by 100-mm VAS | 30 minutes | 2.3 units on a scale |
| Group 2: Gabapentin | Perioperative Nausea as Measured by 100-mm VAS | Baseline | 3.0 units on a scale |
| Group 2: Gabapentin | Perioperative Nausea as Measured by 100-mm VAS | 10 minutes | 1.0 units on a scale |
| Group 2: Gabapentin | Perioperative Nausea as Measured by 100-mm VAS | 30 minutes | 1.0 units on a scale |
Secondary
Side Effects (on a 5-point Scale)
Time frame: Post-operative day 1
Population: Data not collected.
Secondary
Vomiting (on a 5-point Scale)
Time frame: Post-operative day 1
Population: Data not collected.