Gabapentin as an Adjunct to Paracervical Block for Perioperative Pain Management

NCT02944656 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB00084198
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Perioperative pain; Outpatient surgery; Obstetrics/gynecology; Pain management

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Perioperative Pain Level

  Pre-procedure through post-procedure on Study Day 1

• Number of Participants Using Pain Medication

  Postoperative Day 1

• Perioperative Nausea

  Pre-procedure through post-procedure on Study Day 1

• Perioperative Vomiting

  Pre-procedure through post-procedure on Study Day 1

• Anxiety Levels

  Pre-procedure through post-procedure on Study Day 1

Study Arms (2)

Gabapentin group

EXPERIMENTAL

This group will receive local anesthesia per clinic protocol plus Gabapentin 600mg 1-2 hours preoperatively.

Drug: Gabapentin

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Gabapentin DRUG

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.

Also known as: Gaba, Neurontin

Gabapentin group

Placebo DRUG

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.

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• Society of Family Planning: collaborator

Study Sites (1)

Atlanta Women's Center

Atlanta, Georgia, 30342, United States

Location

Related Publications (1)

• 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.

  PMID: 32534843 DERIVED

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Gabapentin; gamma-Aminobutyric Acid

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Tiffany Hailstorks, MD, MPH
• Organization: Emory University

tiffany.p.hailstorks@emory.edu

404-778-1385

Study Officials

• Lisa Haddad, MD, MS, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 26, 2016
• Study Start: December 8, 2016
• Primary Completion: June 26, 2018
• Study Completion: June 26, 2018
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)