PainPhase 4GabaNCT02944656
Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management
A Phase 4 study testing Gabapentin in people with Pain, run by Emory University at 1 site in United States.
Trial summary
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. 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
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2016to 26 Jun 2018
- Phase
- Phase 4
- 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 >=18 years-old
- Presenting for a surgical abortion
- Fluency in English and able to provide informed consent
- Has a driver to take them home following the procedure
Who cannot join
- Allergy, sensitivity or contraindication to gabapentin
- Severe renal disease
- Currently using gabapentin or pregabalin
- Contraindication to outpatient abortion under local anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management for Surgical Abortion: a Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Pain
- Being tested
- Gabapentin, Placebo
- Keywords
- Perioperative pain, Outpatient surgery, Obstetrics/gynecology, Pain management
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Gaba, Neurontin
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin group | Experimental | This group will receive local anesthesia per clinic protocol plus Gabapentin 600mg 1-2 hours preoperatively. Receives: Drug: Gabapentin |
| Placebo group | Placebo comparator | This group will receive local anesthesia per clinic protocol plus placebo 1-2 hours preoperatively. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the procedure on Study Day 1
Secondary outcomes (11)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start8 Dec 2016
- Primary completion26 Jun 2018
- Study completion26 Jun 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Lisa Haddad, Emory University
- Investigators
- Lisa Haddad, MD, MS, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944656
- Sponsor's protocol ID
- IRB00084198
- Acronym
- Gaba
- Status last verified
- Jul 2019
- First submitted
- 13 Oct 2016
- Last updated
- 8 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32534843
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management for Surgical Abortion: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02944656
- Acronym / sponsor ID
- Gaba / IRB00084198
- Conditions
- Pain
- Keywords
- Perioperative pain, Outpatient surgery, Obstetrics/gynecology, Pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- 8 Dec 2016 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Posted 8 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin group | Experimental | Drug: GabapentinThis group will receive local anesthesia per clinic protocol plus Gabapentin 600mg 1-2 hours preoperatively. |
| Placebo group | Placebo comparator | Drug: PlaceboThis group will receive local anesthesia per clinic protocol plus placebo 1-2 hours preoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women >=18 years-old
- Presenting for a surgical abortion
- Fluency in English and able to provide informed consent
- Has a driver to take them home following the procedure
Key exclusion criteria (4 listed)
- Allergy, sensitivity or contraindication to gabapentin
- Severe renal disease
- Currently using gabapentin or pregabalin
- Contraindication to outpatient abortion under local anesthesia
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: Gaba, NeurontinParticipants 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. | Drug | Gabapentin group |
| PlaceboParticipants 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. | Drug | Placebo group |
Primary outcome
Pain at Time of Uterine Evacuation
Time frame: During the procedure on Study Day 1
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.
11 secondary outcomes
Perioperative Pain Level
Time frame: Pre-procedure through post-procedure on Study Day 1
Number of Participants Using Pain Medication
Time frame: Postoperative Day 1
Perioperative Nausea
Time frame: Pre-procedure through post-procedure on Study Day 1
Perioperative Vomiting
Time frame: Pre-procedure through post-procedure on Study Day 1
Anxiety Levels
Time frame: Pre-procedure through post-procedure on Study Day 1
Side Effects
Time frame: 10 and 30 minutes post procedure on Study Day 1
Moderate Pain at Postoperation Follow-up Assessment
Time frame: Postoperative Day 1
Severe Pain at Postoperation Follow-up Assessment
Time frame: Postoperative Day 1
Nausea or Vomiting at Postoperation Follow-up Assessment
Time frame: Postoperative Day 1
Vomiting Since Leaving Clinic
Time frame: Postoperative Day 1
Overall Satisfaction With the Procedure
Time frame: Postoperative Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32534843Hailstorks 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.
- 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.
Lisa Haddad, MD, MS, MPH principal investigator
Emory University
1 site 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 Emory University 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 4 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 8 Aug 2019. 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?
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?
Yes. Results are posted in the registry (first posted 8 Aug 2019). 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 at Time of Uterine Evacuation (time frame: During the procedure on Study Day 1). 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 NCT02944656, 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 8 Aug 2019.