Clinical trial NCT02944656: Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management
Official title: Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management for Surgical Abortion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Perioperative pain
Outpatient surgery
Obstetrics/gynecology
Pain management
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2016-10-26
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain at Time of Uterine Evacuation
timeFrame: During the procedure on Study Day 1
Secondary outcomes:
measure: Perioperative Pain Level
timeFrame: Pre-procedure through post-procedure on Study Day 1
measure: Number of Participants Using Pain Medication
timeFrame: Postoperative Day 1
measure: Perioperative Nausea
timeFrame: Pre-procedure through post-procedure on Study Day 1
measure: Perioperative Vomiting
timeFrame: Pre-procedure through post-procedure on Study Day 1
measure: Anxiety Levels
timeFrame: Pre-procedure through post-procedure on Study Day 1
measure: Side Effects
timeFrame: 10 and 30 minutes post procedure on Study Day 1
measure: Moderate Pain at Postoperation Follow-up Assessment
timeFrame: Postoperative Day 1
measure: Severe Pain at Postoperation Follow-up Assessment
timeFrame: Postoperative Day 1
measure: Nausea or Vomiting at Postoperation Follow-up Assessment
timeFrame: Postoperative Day 1
measure: Vomiting Since Leaving Clinic
timeFrame: Postoperative Day 1
measure: Overall Satisfaction With the Procedure
timeFrame: Postoperative Day 1
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Women's Center
state: Georgia
Study officials:
affiliation: Emory University
name: Lisa Haddad, MD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.