Clinical trial NCT02725710: Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration
Official title: Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Other Abortion
Spontaneous Abortion
Keywords: uterine aspiration
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure
timeFrame: 5 minutes
Secondary outcomes:
measure: Pain Score on the 100-mm VAS
timeFrame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute
measure: Perioperative Nausea as Measured by 100-mm VAS
timeFrame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
measure: Number of Subjects Experiencing Perioperative Vomiting
timeFrame: Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes
measure: Perioperative Anxiety as Measured by the 100-mm VAS
timeFrame: 5 minutes, 10 minutes, 30 minutes, discharge
measure: Number of Subjects Using Pain Medications
timeFrame: 24 hours post-operatively
measure: Number of Subjects Experiencing Side Effects
timeFrame: 10 minutes post-procedure
measure: Pain (on a 5-point Scale)
timeFrame: Post-operative day 1
measure: Nausea (on a 5-point Scale)
timeFrame: Post-operative day 1
measure: Vomiting (on a 5-point Scale)
timeFrame: Post-operative day 1
measure: Side Effects (on a 5-point Scale)
timeFrame: Post-operative day 1
measure: General Satisfaction With the Procedure (on a 5-point Scale)
timeFrame: Post-operative day 1
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Beverly Gray, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gray BA, Hagey JM, Crabtree D, Wynn C, Weber JM, Pieper CF, Haddad LB. Gabapentin for Perioperative Pain Management for Uterine Aspiration: A Randomized Controlled Trial. Obstet Gynecol. 2019 Sep;134(3):611-619. doi: 10.1097/AOG.0000000000003398.