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Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management (Gaba)

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ClinicalTrials.gov Identifier: NCT02944656
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Lisa Haddad, Emory University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Gabapentin Drug: Placebo Phase 4

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

The use of gabapentin in the setting of abortion has never been evaluated. 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management for Surgical Abortion: a Randomized Controlled Trial
Actual Study Start Date : December 8, 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gabapentin group
This group will receive local anesthesia per clinic protocol plus Gabapentin 600mg 1-2 hours preoperatively.
Drug: Gabapentin
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.
Other Names:
  • Gaba
  • Neurontin

Placebo Comparator: Placebo group
This group will receive local anesthesia per clinic protocol plus placebo 1-2 hours preoperatively.
Drug: Placebo
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.




Primary Outcome Measures :
  1. Pain at time of uterine evacuation [ Time Frame: Study Day 1, 1-2 hours after drug administration ]
    The primary outcome measure will be pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation.


Secondary Outcome Measures :
  1. Change in perioperative pain level [ Time Frame: Study Day 1 to Postoperative Day 1 ]
    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. Pain will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, 30 minutes following the procedure, at discharge, and at Postoperative Day 1.

  2. Change in perioperative nausea [ Time Frame: Study Day 1 to Postoperative Day 1 ]
    Nausea level at a variety of time points will be measured using a 100-mm visual analog scale (VAS) to log the change in nausea levels between the study arms. Nausea will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, 30 minutes following the procedure, at discharge, and at Postoperative Day 1.

  3. Change in perioperative vomiting [ Time Frame: Study Day 1 to Postoperative Day 1 ]
    Participants will report the number of times they have vomited during the perioperative period to assess changes in vomiting incidences between the study arms. Vomiting will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, 30 minutes following the procedure, at discharge, and at Postoperative Day 1.

  4. Change in anxiety levels [ Time Frame: Study Day 1, after the procedure ]
    Participants will report how much anxiety they are currently experiencing by marking on a sliding scale ranging from "No Anxiety" to "Extremely Anxious". Current anxiety level will be reported at a variety of time points to assess the changes in anxiety levels between the study arms. Anxiety will be assessed at 10 minutes after the procedure, 30 minutes after the procedure, and at discharge.

  5. Anxiety level [ Time Frame: Postoperative Day 1 ]
    At the Postoperative Day 1 visit, participants will report if they have been been feeling worried or anxious during the previous 24 hours using a range between 0 (all of the time) to 10 (none of the time).

  6. General satisfaction with the procedure [ Time Frame: Postoperative Day 1 ]
    General satisfaction with the procedure will be measure on a 10-point scale on the day after the procedure, where 0 = very dissatisfied and 10 = very satisfied.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Allergy, sensitivity or contraindication to gabapentin
  • Severe renal disease
  • Currently using gabapentin or pregabalin
  • Contraindication to outpatient abortion under local anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944656


Contacts
Contact: Tiffany Hailstorks, MD [404] 778-1385
Contact: Lisa Haddad, MD, MS, MPH [404] 778-1385

Locations
United States, Georgia
Atlanta Women's Center Recruiting
Atlanta, Georgia, United States, 30342
Contact: Tiffany Hailstorks, MD    404-778-1385      
Contact: Lisa Haddad, MD, MS, MPH    [404] 778-1385      
Principal Investigator: Lisa Haddad, MD, MS, MPH         
Sponsors and Collaborators
Emory University
Society of Family Planning
Investigators
Principal Investigator: Lisa Haddad, MD, MS, MPH Emory University

Responsible Party: Lisa Haddad, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02944656     History of Changes
Other Study ID Numbers: IRB00084198
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lisa Haddad, Emory University:
Perioperative pain
Outpatient surgery
Obstetrics/gynecology
Pain management

Additional relevant MeSH terms:
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents