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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Placebo | Active Comparator | Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. |
|
| Group 2: Gabapentin | Active Comparator | Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 600mg Gabapentin administered orally 1-2 hours prior to procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute |
| Perioperative Nausea as Measured by 100-mm VAS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Gray, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27701 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31403587 | Derived | Gray BA, Hagey JM, Crabtree D, Wynn C, Weber JM, Pieper CF, Haddad LB. Gabapentin for Perioperative Pain Management for Uterine Aspiration: A Randomized Controlled Trial. Obstet Gynecol. 2019 Sep;134(3):611-619. doi: 10.1097/AOG.0000000000003398. |
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One subject randomized to gabapentin withdrew from the procedure.
Recruited between August 2016 and June 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Group 2: Gabapentin |
| 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 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. | Posted | Mean | Standard Deviation | score on a scale | 5 minutes |
|
10 minutes post-procedure
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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 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeremy M. Weber | Duke University | 919-681-4561 | jeremy.m.weber@duke.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 16, 2016 | Jun 11, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Placebo | Drug | Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure |
|
|
Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life. |
| Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes |
| 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 | Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious. | 5 minutes, 10 minutes, 30 minutes, discharge |
| Number of Subjects Using Pain Medications | Pain medications included ibuprofen and oxycodone. | 24 hours post-operatively |
| Number of Subjects Experiencing Side Effects | Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia. | 10 minutes post-procedure |
| Pain (on a 5-point Scale) | Post-operative day 1 |
| 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 |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Pain | Measured using the 100-mm visual analog scale (VAS), where 0 means no pain and 100 means worst pain in my life. | Median | Inter-Quartile Range | units on a scale |
|
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes |
|
|
|
| Secondary | Number of Subjects Experiencing Perioperative Vomiting | Posted | Count of Participants | Participants | Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes |
|
|
|
| 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. | One subject in the placebo group did not have anxiety at discharge measured. | Posted | Median | Inter-Quartile Range | units on a scale | 5 minutes, 10 minutes, 30 minutes, discharge |
|
|
|
| Secondary | Number of Subjects Using Pain Medications | Pain medications included ibuprofen and oxycodone. | The number of subjects analyzed for "ibuprofen and oxycodone" and "oxycodone only" reflects the number of subjects that received a prescription for opiates. | Posted | Count of Participants | Participants | 24 hours post-operatively |
|
|
|
| Secondary | Number of Subjects Experiencing Side Effects | Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia. | Posted | Count of Participants | Participants | 10 minutes post-procedure |
|
|
|
| Secondary | Pain (on a 5-point Scale) | Data not collected. | Posted | Post-operative day 1 |
|
|
| Secondary | Nausea (on a 5-point Scale) | Data not collected. | Posted | Post-operative day 1 |
|
|
| Secondary | Vomiting (on a 5-point Scale) | Data not collected. | Posted | Post-operative day 1 |
|
|
| Secondary | Side Effects (on a 5-point Scale) | Data not collected. | Posted | Post-operative day 1 |
|
|
| Secondary | General Satisfaction With the Procedure (on a 5-point Scale) | Data not collected. | Posted | Post-operative day 1 |
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 40 |
| 48 |
| EG001 | 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 | 0 | 47 | 0 | 47 | 43 | 47 |
| Ataxia | Nervous system disorders | Non-systematic Assessment |
|
| Somnolence | General disorders | Non-systematic Assessment |
|
| Asthenia | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Amblyopia | Eye disorders | Non-systematic Assessment |
|
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| 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 |
| D002241 | Carbohydrates |
| 30 minutes |
|
| 30 minutes |
|
| 30 minutes |
|
| 10 minutes |
|
|
| 30 minutes |
|
|
| Discharge |
|
|
| Ibuprofen only |
|
|
| Ibuprofen and oxycodone |
|
|
| Oxycodone only |
|
|
| Somnolence |
|
| Asthenia |
|
| Headache |
|
| Amblyopia |
|