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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.
Project Summary
Justification for the project
One half of all pregnancies among American women are unintended, with nearly 4 in 10 ending in pregnancy termination by abortion. Elective abortions are among the most common outpatient surgical procedure, with an estimated 46 million performed worldwide annually. The management of pain is critical to patient care throughout the abortion experience since the vast majority of women will experience pain with the procedure. Patients are most affected by pain during paracervical block, cervical dilation, suction aspiration, and post operatively with uterine cramping. Innovation in pain control and reduction of anxiety, nausea and vomiting using a low cost, well-tolerated intervention could impact thousands of women each year.
Proposed research
This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.
New features
Gabapentin as an adjunct o pain management has proven beneficial in gynecological surgery. Its use in similar surgical settings as an adjunct to pain management regiments has proven to be beneficial. It is generally well tolerated, inexpensive, has minimal side effects, and few contraindications.
Problems anticipated
The high volume at the study clinic will benefit recruitment efforts, however, as the coordination of this study may potentially disrupt clinic flow there will be limits on daily recruitment. Postoperative follow-up may be challenging, thus to reduce the impact of loss to follow-up, most of the outcomes are measured on the same day as the procedure. Further, multiple contact approaches will be employed and a second incentive offered after completion of the postoperative assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin group | Experimental | This group will receive local anesthesia per clinic protocol plus Gabapentin 600mg 1-2 hours preoperatively. |
|
| Placebo group | Placebo Comparator | This group will receive local anesthesia per clinic protocol plus placebo 1-2 hours preoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Participants in this group will receive 600 mg of gabapentin given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion. Gabapentin is an FDA approved medication that is used to prevent seizures and to treat various forms of chronic and acute pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Time of Uterine Evacuation | The primary outcome measure is a pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation. "No pain" is scored as 0 and "worst pain imaginable" is scored as 100. | During the procedure on Study Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative Pain Level | Pain level at a variety of time points will be measured using a 100-mm visual analog scale (VAS) to log the change in pain levels between the study arms. "No pain" is scored as 0 and "worst pain imaginable" is scored as 100. Pain will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, and 30 minutes following the procedure (at discharge). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Haddad, MD, MS, MPH | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlanta Women's Center | Atlanta | Georgia | 30342 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32534843 | Derived | Hailstorks TP, Cordes SMD, Cwiak CA, Gray BA, Ge L, Moore RH, Haddad LB. Gabapentin as an adjunct to paracervical block for perioperative pain management for first-trimester uterine aspiration: a randomized controlled trial. Am J Obstet Gynecol. 2020 Dec;223(6):884.e1-884.e10. doi: 10.1016/j.ajog.2020.06.011. Epub 2020 Jun 11. |
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A total of 122 individuals were eligible and consented to participate in the study. Six withdrew prior to randomization and an additional 2 withdrew prior to beginning the study, resulting in 114 receiving the intervention.
Participants were recruited from the Atlanta Women's Center in Atlanta, Georgia. Enrollment began on December 8, 2016 and all study procedures concluded on June 26, 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin Group | Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure. |
| FG001 | Placebo Group | Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The baseline population includes participants completing all study procedures on the day of surgery.
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin Group | Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure. |
| BG001 | Placebo Group | Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure. |
| 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 | Pain at Time of Uterine Evacuation | The primary outcome measure is a pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation. "No pain" is scored as 0 and "worst pain imaginable" is scored as 100. | Participants completing all assessments on the day of the procedure are included in this analysis. | Posted | Mean | Standard Error | score on a scale | During the procedure on Study Day 1 |
|
Data on adverse events were collected from the time of investigational medication administration through the follow up phone call on the day after the procedure.
In addition to specific side effects collected as an outcome measure, adverse effects were tracked and monitored during the study. An adverse event is defined as any health-related reaction, effect, toxicity or abnormal laboratory result experienced during the course of the study, irrespective of relationship to the study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gabapentin Group | Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low Blood Pressure | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Hailstorks, MD, MPH | Emory University | 404-778-1385 | tiffany.p.hailstorks@emory.edu |
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| 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 8, 2016 | Jul 2, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D005680 | gamma-Aminobutyric Acid |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
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|
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| Placebo | Drug | Participants in this group will receive 600 mg of gelatin capsules that are identical in appearance to gabapentin capsules. The placebo will be given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion. |
|
| Pre-procedure through post-procedure on Study Day 1 |
| Number of Participants Using Pain Medication | The number of participants reporting filling and using the prescription for ibuprofen postoperatively. During the follow-up phone call on the day after the procedure, participants were asked whether or not they filled the pain medication prescription and if they took any of the medication. | Postoperative Day 1 |
| Perioperative Nausea | Nausea level was measured using a 100-mm visual analog scale (VAS) to log the change in nausea levels between the study arms. No nausea is reported as 0 while "worst nausea I have ever felt" is reported at 100. Nausea was reported immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure. | Pre-procedure through post-procedure on Study Day 1 |
| Perioperative Vomiting | Participants reported if they vomited during the perioperative period to assess changes in vomiting incidences between the study arms. Vomiting is reported for the time periods of immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure. | Pre-procedure through post-procedure on Study Day 1 |
| Anxiety Levels | Participants reported how much anxiety they were currently experiencing on a 100-point scale where "No Anxiety" is scored as 0 and "Extremely Anxious" is scored as 100. Anxiety is reported for the time periods of immediately prior to the procedure, 10 minutes after the procedure, and 30 minutes after the procedure. | Pre-procedure through post-procedure on Study Day 1 |
| Side Effects | Participants were asked if they experienced dizziness, lack of muscle control, sleepiness or drowsiness, weakness or lack of energy, headache, or visual changes. | 10 and 30 minutes post procedure on Study Day 1 |
| Moderate Pain at Postoperation Follow-up Assessment | During the Postoperative Day 1 phone call, participants self reported how much they experienced moderate pain in the last 24 hours where 10 = none of the time and 0 = all of the time. "Moderate pain" was defined according to the perception of each participant. | Postoperative Day 1 |
| Severe Pain at Postoperation Follow-up Assessment | During the Postoperative Day 1 phone call, participants self reported how much they experienced severe pain in the last 24 hours where 10 = none of the time and 0 = all of the time. "Severe pain" was defined according to the perception of each participant. | Postoperative Day 1 |
| Nausea or Vomiting at Postoperation Follow-up Assessment | During the Postoperative Day 1 phone call, participants self reported how much they experienced nausea or vomiting in the last 24 hours where 10 = none of the time and 0 = all of the time. Nausea and vomiting were self-reported together as a single outcome. | Postoperative Day 1 |
| Vomiting Since Leaving Clinic | During the Postoperative Day 1 phone call, participants self reported whether or not they had vomited since leaving the clinic. | Postoperative Day 1 |
| Overall Satisfaction With the Procedure | Overall satisfaction with the procedure was assessed on a 10-point scale on the day after the procedure, where 1 = very dissatisfied and 10 = very satisfied. | Postoperative Day 1 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gestational age | Mean | Standard Deviation | days |
|
|
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| Secondary | Perioperative Pain Level | Pain level at a variety of time points will be measured using a 100-mm visual analog scale (VAS) to log the change in pain levels between the study arms. "No pain" is scored as 0 and "worst pain imaginable" is scored as 100. Pain will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, and 30 minutes following the procedure (at discharge). | Participants completing all assessments on the day of the procedure are included in this analysis. | Posted | Mean | Standard Error | score on a scale | Pre-procedure through post-procedure on Study Day 1 |
|
|
|
| Secondary | Number of Participants Using Pain Medication | The number of participants reporting filling and using the prescription for ibuprofen postoperatively. During the follow-up phone call on the day after the procedure, participants were asked whether or not they filled the pain medication prescription and if they took any of the medication. | Participants completing the follow up assessment one day after the procedure are included in this analysis. | Posted | Count of Participants | Participants | Postoperative Day 1 |
|
|
|
| Secondary | Perioperative Nausea | Nausea level was measured using a 100-mm visual analog scale (VAS) to log the change in nausea levels between the study arms. No nausea is reported as 0 while "worst nausea I have ever felt" is reported at 100. Nausea was reported immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure. | Participants completing all assessments on the day of the procedure are included in this analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Pre-procedure through post-procedure on Study Day 1 |
|
|
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| Secondary | Perioperative Vomiting | Participants reported if they vomited during the perioperative period to assess changes in vomiting incidences between the study arms. Vomiting is reported for the time periods of immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure. | Participants completing all assessments on the day of the procedure are included in this analysis. | Posted | Count of Participants | Participants | Pre-procedure through post-procedure on Study Day 1 |
|
|
|
| Secondary | Anxiety Levels | Participants reported how much anxiety they were currently experiencing on a 100-point scale where "No Anxiety" is scored as 0 and "Extremely Anxious" is scored as 100. Anxiety is reported for the time periods of immediately prior to the procedure, 10 minutes after the procedure, and 30 minutes after the procedure. | Participants completing all assessments on the day of the procedure are included in this analysis. | Posted | Median | Inter-Quartile Range | score on a scale | Pre-procedure through post-procedure on Study Day 1 |
|
|
|
| Secondary | Side Effects | Participants were asked if they experienced dizziness, lack of muscle control, sleepiness or drowsiness, weakness or lack of energy, headache, or visual changes. | This analysis includes participants responding to the side effects questions. Two did not answer any questions. Two participants in the gabapentin group did not complete the side effect assessment at 30 minutes post-procedure. One participant in the placebo group did not respond to the assessment of weakness at 30 minutes post-procedure. | Posted | Count of Participants | Participants | 10 and 30 minutes post procedure on Study Day 1 |
|
|
|
| Secondary | Moderate Pain at Postoperation Follow-up Assessment | During the Postoperative Day 1 phone call, participants self reported how much they experienced moderate pain in the last 24 hours where 10 = none of the time and 0 = all of the time. "Moderate pain" was defined according to the perception of each participant. | Participants completing the follow up assessment one day after the procedure are included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Postoperative Day 1 |
|
|
|
| Secondary | Severe Pain at Postoperation Follow-up Assessment | During the Postoperative Day 1 phone call, participants self reported how much they experienced severe pain in the last 24 hours where 10 = none of the time and 0 = all of the time. "Severe pain" was defined according to the perception of each participant. | Participants completing the follow up assessment one day after the procedure are included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Postoperative Day 1 |
|
|
|
| Secondary | Nausea or Vomiting at Postoperation Follow-up Assessment | During the Postoperative Day 1 phone call, participants self reported how much they experienced nausea or vomiting in the last 24 hours where 10 = none of the time and 0 = all of the time. Nausea and vomiting were self-reported together as a single outcome. | Participants completing the follow up assessment one day after the procedure are included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | Postoperative Day 1 |
|
|
|
| Secondary | Vomiting Since Leaving Clinic | During the Postoperative Day 1 phone call, participants self reported whether or not they had vomited since leaving the clinic. | Participants completing the follow up assessment one day after the procedure are included in this analysis. | Posted | Count of Participants | Participants | Postoperative Day 1 |
|
|
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| Secondary | Overall Satisfaction With the Procedure | Overall satisfaction with the procedure was assessed on a 10-point scale on the day after the procedure, where 1 = very dissatisfied and 10 = very satisfied. | Participants completing the follow up assessment one day after the procedure are included in this analysis. | Posted | Count of Participants | Participants | Postoperative Day 1 |
|
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|
| 0 |
| 54 |
| 0 |
| 54 |
| 1 |
| 54 |
| EG001 | Placebo Group | Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure. | 0 | 57 | 0 | 57 | 1 | 57 |
| Increased nausea and vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000144 |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| 10 minutes post-procedure |
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| 30 minutes post-procedure |
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| 30 minutes post-procedure |
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| 30 minutes post-procedure |
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| 30 minutes post-procedure |
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| Dizziness 30 minutes post-procedure |
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| Lack of muscle control 10 minutes post-procedure |
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| Lack of muscle control 30 minutes post-procedure |
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| Sleepiness/drowsiness 10 minutes post-procedure |
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| Sleepiness/drowsiness 30 minutes post-procedure |
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| Weakness 10 minutes post-procedure |
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| Weakness 30 minutes post-procedure |
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| Headache 10 minutes post-procedure |
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| Headache 30 minutes post-procedure |
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| Vision changes 10 minutes post-procedure |
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| Vision changes 30 minutes post-procedure |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| 7 |
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| 8 |
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| 9 |
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| 10 (very satisfied) |
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