Gabapentin for Pain Management During Dilation and Evacuation

Pain Clinical Trial

— Gabapentin  

Official title:

Gabapentin as an Adjunct for Pain Management During Dilation and Evacuation: A Double-blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03635905
• Other study ID #: 2017-092
• Status: Completed
• Phase: Phase 4
• Start date: May 26, 2017
• Est. completion date: May 20, 2020

Study information

• Verified date: June 2020
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 20, 2020
• Est. primary completion date: May 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Gabapentin
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
• Placebo
Methylcellulose placebo capsule

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Planned Parenthood	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Health Research Institute	Society of Family Planning Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum procedural pain	Measured on 100-mm visual analog scale (higher score = more pain)	Intra-operative
Secondary	Peri-operative pain	Measured by 100-mm visual analog scale (higher score represents more pain)	At enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.
Secondary	Nausea	Measured on 5-point Likert scale (higher score represents more nausea)	At enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.
Secondary	Vomiting	Measured on 5-point Likert scale (higher score represents more vomiting)	At enrollment, prior to procedure, speculum insertion, aspiration, speculum removal, and discharge from clinic, usually within 30 to 120 minutes after completion of procedure.
Secondary	Anxiety	Measured by State Trait Anxiety Inventory. 20 State anxiety items. Higher score represents more anxiety	Prior to procedure and prior to discharge from clinic, usually within 30 to 120 minutes after completion of procedure.
Secondary	Satisfaction with pain management	Measured on 5-point Likert scale (Higher score represents greater satisfaction)	Prior to procedure, prior to discharge from clinic, usually within 30 to 120 minutes after completion of procedure, and post-operative day 1
Secondary	Adverse events	Including but not limited to respiratory depression and sedation reversal	Recorded on day of procedure and post-operative day 1
Secondary	IV sedation doses	Doses of IV fentanyl and IV midazolam administered	Day of procedure