Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin Arm | Active Comparator | Gabapentin 600 mg given 1-2 hours prior to surgical abortion |
|
| Placebo Arm | Placebo Comparator | Placebo (vit C) given 1-2 hours prior to surgical abortion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | Preoperative treatment with Gabapentin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | 100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain | 5 minutes postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score 24 | Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain | 24 hours postop |
| Nausea | Nausea at 24 hours using 100mm VAS, 1=none, 100=extreme |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vani Dandolu, MD | University of Nevada School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birth Control Care Center | Las Vegas | Nevada | 89104 | United States |
All of the participant data de-identified that was collected during the study.
Following publication and terminating 5 years following
Investigators must submit a Material Transfer Agreement for data transfer between UNLV School of Medicine and investigators institution. Investigators who demonstrate a legitimate proposal on the purpose for the data set, their intended analysis and schedule for anticipated publication will be considered. Investigators should submit their publications within 18 months of receiving the data set.
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin Arm | Gabapentin 600 mg given 1-2 hours prior to surgical abortion Gabapentin: Preoperative treatment with Gabapentin |
| FG001 | Placebo Arm | Placebo (vit C) given 1-2 hours prior to surgical abortion Placebos: Preoperative treatment with Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin Arm | Gabapentin 600 mg given 1-2 hours prior to surgical abortion Gabapentin: Preoperative treatment with Gabapentin |
| BG001 | Placebo Arm | Placebo (vit C) given 1-2 hours prior to surgical abortion Placebos: Preoperative treatment with Placebo |
| 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 Score | 100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain | Posted | Median | Inter-Quartile Range | score on a scale | 5 minutes postoperative |
|
24 hours
There were no reported adverse event in the study groups
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gabapentin Arm | Gabapentin 600 mg given 1-2 hours prior to surgical abortion Gabapentin: Preoperative treatment with Gabapentin |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam V. Levy MD | University of Nevada Las Vegas School of Medicine | 702-671-2300 | adam.levy@unlv.edu |
Not provided
| 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 | May 1, 2017 | Nov 6, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
Not provided
Not provided
double-blind placebo-controlled randomized controlled trial
Not provided
Not provided
pharmacy prepared sequentially numbered opaque bottles with identical capsules containing either placebo (vit c) or Gabapentin 600mg, block randomized
| Placebos |
| Drug |
Preoperative treatment with Placebo |
|
| 24 hours postoperative |
| Vomiting | Vomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme | 24 hours postoperative |
| Pain Score at 30 Minutes Postoperative | 100mm Visual analog scale for level of pain, 1-100, 1=no pain, 100= extreme pain | 30 minutes postoperative |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pregnancy History | Count of Participants | Participants |
|
| Living Arrangements | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Pain Score 24 | Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain | We lost to followup 40 in Gaba arm, 48 in the placebo arm at 24 hrs - these patients did not respond to our calls | Posted | Median | Inter-Quartile Range | score on a scale | 24 hours postop |
|
|
|
| Secondary | Nausea | Nausea at 24 hours using 100mm VAS, 1=none, 100=extreme | Posted | Mean | Standard Deviation | VAS 100mm | 24 hours postoperative |
|
|
|
| Secondary | Vomiting | Vomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme | Posted | Mean | Standard Deviation | VAS 100mm | 24 hours postoperative |
|
|
|
| Secondary | Pain Score at 30 Minutes Postoperative | 100mm Visual analog scale for level of pain, 1-100, 1=no pain, 100= extreme pain | Posted | Median | Inter-Quartile Range | score on a scale | 30 minutes postoperative |
|
|
|
| 0 |
| 107 |
| 0 |
| 107 |
| 0 |
| 107 |
| EG001 | Placebo Arm | Placebo (vit C) given 1-2 hours prior to surgical abortion Placebos: Preoperative treatment with Placebo | 0 | 109 | 0 | 109 | 0 | 109 |
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002087 |
| Butyrates |
| 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 |