PainPhase 4GabapentinNCT03635905
Gabapentin for Pain Management During Dilation and Evacuation
A Phase 4 study testing Gabapentin in people with Pain, run by Medstar Health Research Institute at 2 sites in United States.
Trial summary
Justification. Pain control is still an issue for women undergoing second trimester abortion procedures. The investigators propose a randomized controlled double-blinded trial evaluating the use of adjunct gabapentin versus placebo in addition to moderate sedation during D\&E. 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
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 May 2017to 20 May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- English proficiency
- 18 years of age or older
- Gestational age 14 weeks or greater
- Ability to provide informed consent
- Desire to proceed with outpatient D\&E under moderate sedation
Who cannot join
- Contraindications to outpatient abortion or moderate sedation
- Current use of gabapentin (Neurontin®) or pregabalin (Lyrica®)
- Severe renal disease
- Allergy or sensitivity to gabapentin or pregabalin
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood
Washington D.C., District of Columbia, 20002
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Gabapentin as an Adjunct for Pain Management During Dilation and Evacuation: A Double-blind Randomized Controlled Trial
Justification. Pain control is still an issue for women undergoing second trimester abortion procedures. The investigators propose a randomized controlled double-blinded trial evaluating the use of adjunct gabapentin versus placebo in addition to moderate sedation during D\&E. The investigators hypothesize that 600 mg oral gabapentin administered pre-operatively at the time of cervical preparation initiation will improve intra-operative pain control. The investigators also hypothesize that it will improve pre- and post-operative pain, anxiety, nausea, vomiting, and overall satisfaction with pain management during D\&E.
To test the hypotheses the investigators plan to enroll 130 participants who will be randomized 1 to 1 to receive either 600 mg gabapentin or placebo at the initiation of cervical preparation.
Read the detailed description
Over 900,000 abortion procedures are performed annually in the United States [1]. For many women, pain relief during abortion is inadequate despite the use of non-steroidal anti-inflammatory drugs, local anesthetics, opioids, and/or moderate sedation. Research on pain control during abortion has focused on methods for relief during first-trimester suction curettage with little research dedicated to pain during dilation and evacuation (D\&E). Gabapentin (Neurontin) has emerged as an effective adjunct to pain management for a variety of surgical procedures. Gabapentin is inexpensive and is also effective in reducing anxiety, nausea, and vomiting. The addition of pre-operative gabapentin to moderate sedation during D\&E may lead to increased patient satisfaction and pain relief without significantly increasing risk or cost.
Proposed Research. The investigators propose a randomized controlled double-blinded trial evaluating the use of adjunct gabapentin versus placebo in addition to moderate sedation during D\&E. The investigators hypothesize that 600 mg oral gabapentin administered pre-operatively at the time of cervical preparation initiation will improve intra-operative pain control. The investigators also hypothesize that it will improve pre- and post-operative pain, anxiety, nausea, vomiting, and overall satisfaction with pain management during D\&E. The investigators hypothesize that the doses of moderate sedation agents required to obtain adequate sedation will be decreased if participants receive gabapentin, versus placebo. The investigators also plan to compare the risk of adverse events with adjunct gabapentin versus placebo with moderate sedation.
To test the hypotheses the investigators plan to enroll 130 participants who will be randomized 1 to 1 to receive either 600 mg gabapentin or placebo at the initiation of cervical preparation. Baseline characteristics will be recorded. Pain will be assessed pre-operatively, at 3 intraoperative time points, and postoperatively by 100 mm visual analog scale (VAS). The investigators plan to assess satisfaction with pain control, nausea, vomiting, and anxiety preoperatively and post-operatively, using 5-point Likert scales and the State Trait Anxiety Inventory, respectively. A final assessment will be made by phone on post-operative day one to evaluate overall satisfaction and perform a final screen for adverse events.
New features. No publications have evaluated the use of gabapentin during abortion care, although multiple studies are currently underway investigating gabapentin's effects during first trimester abortion and during overnight cervical osmotic dilators. To the investigators knowledge, this will be the first evaluation of gabapentin in conjunction with moderate sedation for pain relief during same-day second trimester abortion.
- Conditions
- Pain
- Being tested
- Gabapentin, Placebo
- Keywords
- abortion, gabapentin, Neurontin, Dilation and evacuation
- Medical subject headings
- Pain, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called (Neurontin)
Gabapentin (Neurontin®) is FDA-approved for the treatment of post-herpetic neuralgia and seizure disorder. Off-label uses include chronic refractory cough, neuropathy, hot flashes, restless leg syndrome, social anxiety disorder, and post-operative pain
PlaceboDrug
Methylcellulose placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Gabapentin (Neurontin)- 600 mg oral administered pre-operatively at the time of cervical preparation Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum procedural pain
Measured on 100-mm visual analog scale (higher score = more pain)
Measured: Intra-operative
Secondary outcomes (7)
Peri-operative pain
Measured by 100-mm visual analog scale (higher score represents more pain)
Measured: At enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.
Nausea
Measured on 5-point Likert scale (higher score represents more nausea)
Measured: At enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.
Vomiting
Measured on 5-point Likert scale (higher score represents more vomiting)
Measured: At enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.
Anxiety
Measured by State Trait Anxiety Inventory. 20 State anxiety items. Higher score represents more anxiety
Measured: Prior to procedure and prior to discharge from clinic, usually within 30 to 120 minutes after completion of procedure.
Satisfaction with pain management
Measured on 5-point Likert scale (Higher score represents greater satisfaction)
Measured: Prior to procedure, prior to discharge from clinic, usually within 30 to 120 minutes after completion of procedure, and post-operative day 1
Adverse events
Including but not limited to respiratory depression and sedation reversal
Measured: Recorded on day of procedure and post-operative day 1
IV sedation doses
Doses of IV fentanyl and IV midazolam administered
Measured: Day of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start26 May 2017
- Primary completion9 May 2019
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning Research Fund
- Responsible party
- Principal investigator, Pamela Lotke, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635905
- Sponsor's protocol ID
- 2017-092
- Acronym
- Gabapentin
- Status last verified
- Jun 2020
- First submitted
- 20 Jul 2018
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brant AR, Reeves MF, Ye PP, Scott RK, Floyd S, Tefera E, Lotke PS. Gabapentin as an adjunct for pain management during dilation and evacuation: A double-blind randomized controlled trial. Contraception. 2023 Feb;118:109892. doi: 10.1016/j.contraception.2022.09.130. Epub 2022 Oct 12.
PubMed 36243129
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin as an Adjunct for Pain Management During Dilation and Evacuation: A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03635905
- Acronym / sponsor ID
- Gabapentin / 2017-092
- Conditions
- Pain
- Keywords
- abortion, gabapentin, Neurontin, Dilation and evacuation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Collaborators
- Society of Family Planning Research Fund
- Study start
- 26 May 2017 (actual)
- Primary completion
- 9 May 2019 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Justification. Pain control is still an issue for women undergoing second trimester abortion procedures. The investigators propose a randomized controlled double-blinded trial evaluating the use of adjunct gabapentin versus placebo in addition to moderate sedation during D\&E. The investigators hypothesize that 600 mg oral gabapentin administered pre-operatively at the time of cervical preparation initiation will improve intra-operative pain control. The investigators also hypothesize that it will improve pre- and post-operative pain, anxiety, nausea, vomiting, and overall satisfaction with pain management during D\&E.
To test the hypotheses the investigators plan to enroll 130 participants who will be randomized 1 to 1 to receive either 600 mg gabapentin or placebo at the initiation of cervical preparation.
Detailed description
Over 900,000 abortion procedures are performed annually in the United States [1]. For many women, pain relief during abortion is inadequate despite the use of non-steroidal anti-inflammatory drugs, local anesthetics, opioids, and/or moderate sedation. Research on pain control during abortion has focused on methods for relief during first-trimester suction curettage with little research dedicated to pain during dilation and evacuation (D\&E). Gabapentin (Neurontin) has emerged as an effective adjunct to pain management for a variety of surgical procedures. Gabapentin is inexpensive and is also effective in reducing anxiety, nausea, and vomiting. The addition of pre-operative gabapentin to moderate sedation during D\&E may lead to increased patient satisfaction and pain relief without significantly increasing risk or cost.
Proposed Research. The investigators propose a randomized controlled double-blinded trial evaluating the use of adjunct gabapentin versus placebo in addition to moderate sedation during D\&E. The investigators hypothesize that 600 mg oral gabapentin administered pre-operatively at the time of cervical preparation initiation will improve intra-operative pain control. The investigators also hypothesize that it will improve pre- and post-operative pain, anxiety, nausea, vomiting, and overall satisfaction with pain management during D\&E. The investigators hypothesize that the doses of moderate sedation agents required to obtain adequate sedation will be decreased if participants receive gabapentin, versus placebo. The investigators also plan to compare the risk of adverse events with adjunct gabapentin versus placebo with moderate sedation.
To test the hypotheses the investigators plan to enroll 130 participants who will be randomized 1 to 1 to receive either 600 mg gabapentin or placebo at the initiation of cervical preparation. Baseline characteristics will be recorded. Pain will be assessed pre-operatively, at 3 intraoperative time points, and postoperatively by 100 mm visual analog scale (VAS). The investigators plan to assess satisfaction with pain control, nausea, vomiting, and anxiety preoperatively and post-operatively, using 5-point Likert scales and the State Trait Anxiety Inventory, respectively. A final assessment will be made by phone on post-operative day one to evaluate overall satisfaction and perform a final screen for adverse events.
New features. No publications have evaluated the use of gabapentin during abortion care, although multiple studies are currently underway investigating gabapentin's effects during first trimester abortion and during overnight cervical osmotic dilators. To the investigators knowledge, this will be the first evaluation of gabapentin in conjunction with moderate sedation for pain relief during same-day second trimester abortion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: GabapentinGabapentin (Neurontin)- 600 mg oral administered pre-operatively at the time of cervical preparation |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English proficiency
- 18 years of age or older
- Gestational age 14 weeks or greater
- Ability to provide informed consent
- Desire to proceed with outpatient D\&E under moderate sedation
Key exclusion criteria (4 listed)
- Contraindications to outpatient abortion or moderate sedation
- Current use of gabapentin (Neurontin®) or pregabalin (Lyrica®)
- Severe renal disease
- Allergy or sensitivity to gabapentin or pregabalin
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 |
|---|---|---|
| GabapentinAlso: (Neurontin)Gabapentin (Neurontin®) is FDA-approved for the treatment of post-herpetic neuralgia and seizure disorder. Off-label uses include chronic refractory cough, neuropathy, hot flashes, restless leg syndrome, social anxiety disorder, and post-operative pain | Drug | Gabapentin |
| PlaceboMethylcellulose placebo capsule | Drug | Placebo |
Primary outcome
Maximum procedural pain
Time frame: Intra-operative
Measured on 100-mm visual analog scale (higher score = more pain)
7 secondary outcomes
Peri-operative pain
Time frame: At enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.
Nausea
Time frame: At enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.
Vomiting
Time frame: At enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.
Anxiety
Time frame: Prior to procedure and prior to discharge from clinic, usually within 30 to 120 minutes after completion of procedure.
Satisfaction with pain management
Time frame: Prior to procedure, prior to discharge from clinic, usually within 30 to 120 minutes after completion of procedure, and post-operative day 1
Adverse events
Time frame: Recorded on day of procedure and post-operative day 1
IV sedation doses
Time frame: Day of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Derived from this study: PubMed 36243129Brant AR, Reeves MF, Ye PP, Scott RK, Floyd S, Tefera E, Lotke PS. Gabapentin as an adjunct for pain management during dilation and evacuation: A double-blind randomized controlled trial. Contraception. 2023 Feb;118:109892. doi: 10.1016/j.contraception.2022.09.130. Epub 2022 Oct 12.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin in people with Pain, run by Medstar Health Research Institute at 2 sites 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 5 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 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum procedural pain (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03635905, which also lists 1 linked publication.
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 18 Jun 2020.