Gabapentin for Relief of Immediate Postoperative Pain

Postoperative Pain Clinical Trial

— GRIPP  

Official title:

GRIPP: Gabapentin for Relief of Immediate Postoperative Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03750773
• Other study ID #: 1809661339
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: July 2, 2019
• Est. completion date: April 2020

Study information

• Verified date: July 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to use gabapentin as an additional or alternative treatment for short term pain control following cesarean delivery in order to reduce the use of opioid pain medication and improve overall pain control following surgery.

Description:

This is a randomized, placebo controlled, double blind study. After consent, the subject will complete a Depression Screening to establish a baseline score. Within 2 hours following completion of a cesarean section, the subject will be given the study drug (600mg Gabapentin) or placebo. She will be given this every 8 hours for 48 hours scheduled. She will also have the option to take routine opioid pain medication if her pain is uncontrolled. She will be asked to rate her postoperative pain on a Visual Analog Scale prior to receiving the study drug, 2-4 hours after each dose, and at 24, 36, and 48 hours postoperatively. For breastfeeding infants, data will be collected regarding overall feeding quality, somnolence levels, gestational age at birth, infant weight at birth and discharge, the highest bilirubin level while inpatient and any treatment for this as applicable. The subject will complete the Depression Scale again at 48 hours following delivery. At one week postpartum, they will receive a phone call and the following will be addressed: a final pain survey, a Depression survey, nausea level, number of pain pills left in their prescription, adverse events, whether or not they would take the study drug again if they should happen to have another cesarean section, and infant well-being if breastfeeding.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Pregnant women at least 18 years of age

2. Gestational age > or = to 30 weeks

3. Singleton gestation

4. Women undergoing a non-emergent cesarean delivery

5. Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean

6. Ability to undergo the informed consent process in English

Exclusion Criteria:

1. Vertical skin incision

2. General anesthesia for cesarean

3. History of major depression or postpartum depression requiring medication

4. Chronic opiate use during pregnancy, defined as anyone who has taken an opioid or opioid replacement therapy in the 3 days prior to admission for delivery. This does not include opioids given for labor anesthesia.

5. Magnesium sulfate treatment postpartum

6. Preexisting fibromyalgia, chronic pain syndrome, or rheumatologic disorder

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Gabapentin 600mg
Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.
• Placebo oral capsule
Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine milligram equivalents consumed in the first 48 hours postoperatively	The total morphine milligram equivalents consumed by the subjects within the first 48 hours postoperatively will be recorded and compared between the two arms.	48 hours
Secondary	Total morphine milligram equivalents from hospital discharge to one week postoperatively	The total number of pills of postoperative opioid pain medication consumed will be recorded, converted into morphine milligram equivalents, and compared between the two arms.	one week
Secondary	Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively	Each subject will report a measure of pain on a Visual Analog Scale before and 2-4 hours after each dose of study drug or placebo, and at 24, 36, and 48 hours postoperatively.	48 hours
Secondary	Number and type of adverse events potentially associated with study drug (Safety and Tolerability)	Adverse events of maternal dizziness, nausea, notable peripheral edema, suicidal behavior or ideation, infant somnolence, and drug reactions will be recorded	one week