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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Gabapentin; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Atlanta Women's Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: Neurontin; Gaba
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During the procedure on Study Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Postoperative Day 1

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Lisa Haddad, MD, MS, MPH, Emory University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2016
• Primary Completion (Actual): June 26, 2018
• Study Completion (Actual): June 26, 2018

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 24, 2016
• First Posted (Estimate): October 26, 2016

Study Record Updates

• Last Update Posted (Actual): August 8, 2019
• Last Update Submitted That Met QC Criteria: July 17, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Pain management; Outpatient surgery; Perioperative pain; Obstetrics/gynecology
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: IRB00084198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No