Gabapentin for Perioperative Pain Relief in Surgical Abortion

Pain Control Clinical Trial

Official title:

Gabapentin for Perioperative Pain Relief in Surgical Abortion: a Double-blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292171
• Other study ID #: 734275-7
• Status: Completed
• Phase: Early Phase 1
• Start date: May 1, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: November 2020
• Source: University of Nevada, Las Vegas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gabapentin preoperative use for evaluation of benefit to reduce pain during and after surgical office-based abortion.

Description:

A double-blind placebo controlled trial of gabapentin in the setting of an ambulatory surgical abortion center where patients receive either the routine intravenous sedation, local cervical anesthesia plus 600mg of gabapentin one hour prior to surgery vs. the same regimen plus placebo one hour prior to surgery. Our primary outcome measure will be post-operative validated pain scores using a 11-point visual analog scale (VAS). Secondary measures will include nausea and vomiting during, after and 24 hours after the procedure. A second and third pain assessment using VAS will be made at 30 minutes and at 24 hours postoperatively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women seeking surgical abortion between 5 and 23 6/7 weeks of ultrasound age.
• English or Spanish speaking
• eligible for office-based surgical pregnancy termination

Exclusion Criteria:

• present use of gabapentin or pregabalin,
• renal disease
• sensitivity or allergy to gabapentin
• Missed abortion

Related Conditions & MeSH terms

• Pain Control

Intervention

Drug:
• Gabapentin
Preoperative treatment with Gabapentin
• Placebos
Preoperative treatment with Placebo

Locations

Country	Name	City	State
United States	Birth Control Care Center	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Las Vegas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score	100mm Visual analog scale (VAS) for level of pain, 1-100, 1=no pain, 100= extreme pain	5 minutes postoperative
Secondary	Pain Score 24	Pain at 24 hours postoperative on 100mm VAS, 1=no pain, 100=extreme pain	24 hours postop
Secondary	Nausea	Nausea at 24 hours using 100mm VAS, 1=none, 100=extreme	24 hours postoperative
Secondary	Vomiting	Vomiting at 24 hrs, 100mm VAS, 1=none, 100=extreme	24 hours postoperative
Secondary	Pain Score at 30 Minutes Postoperative	100mm Visual analog scale for level of pain, 1-100, 1=no pain, 100= extreme pain	30 minutes postoperative