Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration

Spontaneous Abortion Clinical Trial

— GABA  

Official title:

Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725710
• Other study ID #: Pro00063872
• Status: Completed
• Phase: Phase 2
• Start date: August 2016
• Est. completion date: June 14, 2018

Study information

• Verified date: June 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled double-blind placebo-controlled trial evaluating the impact of gabapentin given preoperatively on perioperative pain scores for women receiving uterine aspiration between 6 and 14+6 weeks gestation. This study will be a trial included in a prospective meta-analysis evaluating the use of gabapentin on perioperative pain in the abortion setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 14, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women >=18 years-old

• Presenting for a surgical abortion

• No contraindication to outpatient abortion

• No contraindication to gabapentin

• Fluency in English and able to provide informed consent

Exclusion Criteria:

• Allergy, sensitivity or contraindication to gabapentin

• Severe renal disease

• Currently using gabapentin or pregalabin

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Other Abortion
• Spontaneous Abortion

Intervention

Drug:
• Gabapentin
600mg Gabapentin administered orally 1-2 hours prior to procedure
• Placebo
Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure	Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.	5 minutes
Secondary	Pain Score on the 100-mm VAS	Measured at baseline, 10 minutes post-procedure, and 30 minutes post-procedure. Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.	Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute
Secondary	Perioperative Nausea as Measured by 100-mm VAS	Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life.	Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
Secondary	Number of Subjects Experiencing Perioperative Vomiting		Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
Secondary	Perioperative Anxiety as Measured by the 100-mm VAS	Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious.	5 minutes, 10 minutes, 30 minutes, discharge
Secondary	Number of Subjects Using Pain Medications	Pain medications included ibuprofen and oxycodone.	24 hours post-operatively
Secondary	Number of Subjects Experiencing Side Effects	Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia.	10 minutes post-procedure
Secondary	Pain (on a 5-point Scale)		Post-operative day 1
Secondary	Nausea (on a 5-point Scale)		Post-operative day 1
Secondary	Vomiting (on a 5-point Scale)		Post-operative day 1
Secondary	Side Effects (on a 5-point Scale)		Post-operative day 1
Secondary	General Satisfaction With the Procedure (on a 5-point Scale)		Post-operative day 1