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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02725710
• Collaborator: (none)
• Enrollment: 96
• Location: 1
• Arms: 2
• Duration (Months): 22.4
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Other Abortion; Spontaneous Abortion	Drug: Gabapentin; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Gabapentin as an Adjunct to Perioperative Pain Management Regimens for Uterine Aspiration: a Randomized Controlled Trial
• Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Jun 13, 2018
• Actual Study Completion Date: Jun 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1: Placebo Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure.	Drug: Placebo; Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure; Other Names: sugar pill
Active Comparator: Group 2: Gabapentin Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure.	Drug: Gabapentin; 600mg Gabapentin administered orally 1-2 hours prior to procedure; Other Names: Neurontin

Outcome Measures

Primary Outcome Measures

1. Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure [5 minutes]

   Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.

Secondary Outcome Measures

1. Pain Score on the 100-mm VAS [Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute]

   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.

2. Perioperative Nausea as Measured by 100-mm VAS [Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes]

   Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life.

3. Number of Subjects Experiencing Perioperative Vomiting [Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes]

4. Perioperative Anxiety as Measured by the 100-mm VAS [5 minutes, 10 minutes, 30 minutes, discharge]

   Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious.

5. Number of Subjects Using Pain Medications [24 hours post-operatively]

   Pain medications included ibuprofen and oxycodone.

6. Number of Subjects Experiencing Side Effects [10 minutes post-procedure]

   Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia.

7. Pain (on a 5-point Scale) [Post-operative day 1]

8. Nausea (on a 5-point Scale) [Post-operative day 1]

9. Vomiting (on a 5-point Scale) [Post-operative day 1]

10. Side Effects (on a 5-point Scale) [Post-operative day 1]

11. General Satisfaction With the Procedure (on a 5-point Scale) [Post-operative day 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27701

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Beverly Gray, MD, Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 16, 2016

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02725710
• Other Study ID Numbers: Pro00063872
• First Posted: Apr 1, 2016
• Last Update Posted: Jul 2, 2019
• Last Verified: Jun 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Duke University: uterine aspiration
• Additional relevant MeSH terms: Abortion, Spontaneous; Gabapentin

Study Results

Participant Flow

Recruitment Details	Recruited between August 2016 and June 2018.
Pre-assignment Detail	One subject randomized to gabapentin withdrew from the procedure.

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Period Title: Overall Study
STARTED	48	47
COMPLETED	47	47
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin	Total
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure	Total of all reporting groups
Overall Participants	48	47	95
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.8 (6.3)	31.7 (6.1)	31.7 (6.1)
Sex: Female, Male (Count of Participants)
Female	48 100%	47 100%	95 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 10.4%	3 6.4%	8 8.4%
Not Hispanic or Latino	43 89.6%	44 93.6%	87 91.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	5 10.4%	5 10.6%	10 10.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	15 31.3%	16 34%	31 32.6%
White	27 56.3%	26 55.3%	53 55.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 2.1%	0 0%	1 1.1%
Region of Enrollment (participants) [Number]
United States	48 100%	47 100%	95 100%
Baseline Pain (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	3.3	3.0	3.0

Outcome Measures

1. Primary Outcome

Title	Pain Score on 100-mm VAS (Visual Analog Scale) at 5 Minutes Post-procedure
Description	Score range of 0 to 100, where 0 means no pain and 100 means worst pain in my life.
Time Frame	5 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Measure Participants	48	47
Mean (Standard Deviation) [score on a scale]	35.7 (27.5)	37.1 (30.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: Placebo, Group 2: Gabapentin
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.56
	Comments
	Method	Regression, Linear
	Comments

2. Secondary Outcome

Title	Pain Score on the 100-mm VAS
Description	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.
Time Frame	Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minute

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Measure Participants	48	47
Baseline	3.3	3.0
10 minutes	19.8	20.0
30 minutes	12.6	9.5

3. Secondary Outcome

Title	Perioperative Nausea as Measured by 100-mm VAS
Description	Score range of 0 to 100, where 0 means no nausea and 100 means worst nausea in my life.
Time Frame	Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Measure Participants	48	47
Baseline	3.0	3.0
10 minutes	2.5	1.0
30 minutes	2.3	1.0

4. Secondary Outcome

Title	Number of Subjects Experiencing Perioperative Vomiting
Time Frame	Baseline (pre-operatively immediately prior to the procedure), 10 minutes, 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Measure Participants	48	47
Baseline	1 2.1%	0 0%
10 minutes	1 2.1%	2 4.3%
30 minutes	1 2.1%	5 10.6%

5. Secondary Outcome

Title	Perioperative Anxiety as Measured by the 100-mm VAS
Description	Score range of 0 to 100, where 0 means no anxiety and 100 means extremely anxious.
Time Frame	5 minutes, 10 minutes, 30 minutes, discharge

Outcome Measure Data

Analysis Population Description

One subject in the placebo group did not have anxiety at discharge measured.

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Measure Participants	48	47
5 minutes	24.5	23.5
10 minutes	14.5	11.0
30 minutes	13.3	7.0
Discharge	10.5	8.0

6. Secondary Outcome

Title	Number of Subjects Using Pain Medications
Description	Pain medications included ibuprofen and oxycodone.
Time Frame	24 hours post-operatively

Outcome Measure Data

Analysis Population Description

The number of subjects analyzed for "ibuprofen and oxycodone" and "oxycodone only" reflects the number of subjects that received a prescription for opiates.

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Measure Participants	48	47
No pain medication	10 20.8%	17 36.2%
Ibuprofen only	23 47.9%	23 48.9%
Ibuprofen and oxycodone	9 18.8%	6 12.8%
Oxycodone only	6 12.5%	1 2.1%

7. Secondary Outcome

Title	Number of Subjects Experiencing Side Effects
Description	Side effects noted are dizziness, ataxia, somnolence, asthenia, headache, and amblyopia.
Time Frame	10 minutes post-procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Measure Participants	48	47
Dizziness	14 29.2%	20 42.6%
Ataxia	8 16.7%	6 12.8%
Somnolence	37 77.1%	41 87.2%
Asthenia	31 64.6%	27 57.4%
Headache	5 10.4%	5 10.6%
Amblyopia	3 6.3%	3 6.4%

8. Secondary Outcome

Title	Pain (on a 5-point Scale)
Time Frame	Post-operative day 1

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Measure Participants	0	0

9. Secondary Outcome

Title	Nausea (on a 5-point Scale)
Time Frame	Post-operative day 1

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Measure Participants	0	0

10. Secondary Outcome

Title	Vomiting (on a 5-point Scale)
Time Frame	Post-operative day 1

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Measure Participants	0	0

11. Secondary Outcome

Title	Side Effects (on a 5-point Scale)
Time Frame	Post-operative day 1

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Measure Participants	0	0

12. Secondary Outcome

Title	General Satisfaction With the Procedure (on a 5-point Scale)
Time Frame	Post-operative day 1

Outcome Measure Data

Analysis Population Description

Data not collected.

Arm/Group Title	Group 1: Placebo	Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure	Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
Measure Participants	0	0

Adverse Events

Time Frame	10 minutes post-procedure
Arm/Group Title	Group 1: Placebo		Group 2: Gabapentin
Arm/Group Description	Usual perioperative pain management protocol PLUS placebo orally 1-2 hour prior to procedure. Placebo: Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure		Usual perioperative pain management protocol PLUS 600mg Gabapentin administered orally 1-2 hour prior to procedure. Gabapentin: 600mg Gabapentin administered orally 1-2 hours prior to procedure
All Cause Mortality
	Group 1: Placebo		Group 2: Gabapentin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/47 (0%)
Serious Adverse Events
	Group 1: Placebo		Group 2: Gabapentin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/47 (0%)
Other (Not Including Serious) Adverse Events
	Group 1: Placebo		Group 2: Gabapentin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	40/48 (83.3%)		43/47 (91.5%)
Eye disorders
Amblyopia	3/48 (6.3%)		3/47 (6.4%)
General disorders
Somnolence	37/48 (77.1%)		41/47 (87.2%)
Nervous system disorders
Dizziness	14/48 (29.2%)		20/47 (42.6%)
Ataxia	8/48 (16.7%)		6/47 (12.8%)
Asthenia	31/48 (64.6%)		27/47 (57.4%)
Headache	5/48 (10.4%)		5/47 (10.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.