Pain ControlEarly Phase 1NCT04292171
Gabapentin for Perioperative Pain Relief in Surgical Abortion
A Early Phase 1 study testing Gabapentin in people with Pain Control, run by University of Nevada, Las Vegas at 1 site in United States.
Trial summary
Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Control
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Mar 2018
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- present use of gabapentin or pregabalin,
- renal disease
- sensitivity or allergy to gabapentin
- Missed abortion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gabapentin for Perioperative Pain Relief in Surgical Abortion: a Double-blind Randomized Controlled Trial
Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion.
Read the 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.
- Conditions
- Pain Control
- Being tested
- Gabapentin, Placebos
- Keywords
- Gabapentin Abortion
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Preoperative treatment with Gabapentin
PlacebosDrug
Preoperative treatment with Placebo
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin Arm | Active comparator | Gabapentin 600 mg given 1-2 hours prior to surgical abortion Receives: Drug: Gabapentin |
| Placebo Arm | Placebo comparator | Placebo (vit C) given 1-2 hours prior to surgical abortion Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain
Measured: 5 minutes postoperative
Secondary outcomes (4)
Pain Score 24
Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain
Measured: 24 hours postop
Nausea
Nausea at 24 hours using 100mm VAS, 1=none, 100=extreme
Measured: 24 hours postoperative
Vomiting
Vomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme
Measured: 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
Measured: 30 minutes postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start1 May 2017
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind placebo-controlled randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Levy, University of Nevada, Las Vegas
- Investigators
- Vani Dandolu, MD, Study chair, University of Nevada School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292171
- Sponsor's protocol ID
- 734275-7
- Status last verified
- Nov 2020
- First submitted
- 5 Feb 2020
- Last updated
- 2 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the participant data de-identified that was collected during the study.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin for Perioperative Pain Relief in Surgical Abortion: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04292171
- Acronym / sponsor ID
- 734275-7
- Conditions
- Pain Control
- Keywords
- Gabapentin Abortion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 2 Mar 2020 (actual)
- Results
- Posted 2 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- double-blind placebo-controlled randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Gabapentin Arm | Active comparator | Drug: GabapentinGabapentin 600 mg given 1-2 hours prior to surgical abortion |
| Placebo Arm | Placebo comparator | Drug: PlacebosPlacebo (vit C) given 1-2 hours prior to surgical abortion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- present use of gabapentin or pregabalin,
- renal disease
- sensitivity or allergy to gabapentin
- Missed abortion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinPreoperative treatment with Gabapentin | Drug | Gabapentin Arm |
| PlacebosPreoperative treatment with Placebo | Drug | Placebo Arm |
Primary outcome
Pain Score
Time frame: 5 minutes postoperative
100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain
4 secondary outcomes
Pain Score 24
Time frame: 24 hours postop
Nausea
Time frame: 24 hours postoperative
Vomiting
Time frame: 24 hours postoperative
Pain Score at 30 Minutes Postoperative
Time frame: 30 minutes postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All of the participant data de-identified that was collected during the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vani Dandolu, MD study chair
University of Nevada School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Gabapentin in people with Pain Control, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 5 minutes postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.