Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Other Abortion
- Sponsor
- Duke University
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Group 1: Placebo
Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.
Intervention: Placebo
Group 2: Gabapentin
Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.
Intervention: Gabapentin
Outcomes
Primary Outcomes
Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure
Time Frame: 5 minutes
Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.
Secondary Outcomes
- Number of Subjects Experiencing Perioperative Vomiting(Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes)
- Side Effects (on a 5-point Scale)(Post-operative day 1)
- Perioperative Anxiety as Measured by the 100-mm VAS(5 minutes, 10 minutes, 30 minutes, discharge)
- Number of Subjects Using Pain Medications(24 hours post-operatively)
- Nausea (on a 5-point Scale)(Post-operative day 1)
- Pain Score on the 100-mm VAS(Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute)
- Perioperative Nausea as Measured by 100-mm VAS(Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes)
- Number of Subjects Experiencing Side Effects(10 minutes post-procedure)
- Pain (on a 5-point Scale)(Post-operative day 1)
- Vomiting (on a 5-point Scale)(Post-operative day 1)
- General Satisfaction With the Procedure (on a 5-point Scale)(Post-operative day 1)