Gabapentin as Adjunctive Treatment for Postoperative Pain Control

Drug Usage Clinical Trial

Official title:

Effect of Gabapentin on Postoperative Pain Control After a Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490345
• Other study ID #: 1507497375
• Status: Completed
• Phase: Phase 1
• First received: July 1, 2015
• Last updated: August 21, 2017
• Start date: October 2015
• Est. completion date: June 29, 2017

Study information

• Verified date: August 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The specific aims of this research study are to use 600 mg gabapentin as an adjunctive treatment for acute postoperative pain control in order to reduce postoperative opiate consumption and improve postoperative pain control.

Description:

After consent has been obtained for the study and the cesarean has been completed, when the participant is in the recovery room, she will take the first pill of the study drug. This will occur approximately 30-60 minutes after the cesarean is completed. The time of first dose will be noted on the data capture form. The following will then occur:

• Participants will take study capsules (either 600 mg gabapentin or placebo) every 8 hours for the first 48 hours after beginning the study. The nurse on the unit will be sent the study drug in a blinded capsule by the Investigational Pharmacy.

• Participants will be asked about postoperative pain on a Visual Analog Scale by the care nurses or study personnel before each dose of study drug, before receiving any opioid medication, 2-4 hours after study drugs are consumed, at 24, 36 and 48 hours post surgery, and any other times during routine postoperative clinical care would warrant. Women record pain postoperatively on a similar scale as part of routine clinical care. Prescription pain medication will be given per clinical routine care. Study personnel will note how many pills were sent home.

• One week (6-9 days) after the cesarean delivery, participants will be contacted by phone or other preferred method and asked about pain score, somnolence scores, dizziness, nausea, depression, any problems they are experiencing, and asked how many pain pills are left in their prescriptions given when they went home. These data will be recorded.

An Edinburgh Depression Scale will also be administered upon consent, at 48 hours, and again at one week after delivery. If the scores meet the specified criteria, the provider will by notified or if the subject has already been discharged from the hospital, she will be given contact information for follow up care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 29, 2017
• Est. primary completion date: June 29, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women at least 18 years of age

• Singleton gestation

• Gestational age equal to or greater than 30 weeks

• Women undergoing a non-emergent (often scheduled) repeat cesarean delivery

• Spinal anesthesia utilized during cesarean

Exclusion Criteria:

• History of opiate abuse

• Women on opiates during pregnancy

• Women requiring treatment with magnesium sulfate postpartum

• Preexisting Fibromyalgia, chronic pain syndrome, or rheumatologic disorder

• General anesthesia required for cesarean

• Plans to breastfeed

• History of major depression or postpartum depression requiring medication

• Planned classical cesarean section

Related Conditions & MeSH terms

• Drug Usage
• Pain, Postoperative

Intervention

Drug:
• gabapentin
gabapentin usage as adjunctive treatment for pain control
• Placebo
Identical placebo

Locations

Country	Name	City	State
United States	Eskenazi Health	Indianapolis	Indiana
United States	Eskenazi Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of opioid equivalents consumed		48 hours after cesarean delivery
Secondary	Amount of opioid equivalents consumed		one week after cesarean delivery
Secondary	VAS pain scores		one week after cesarean delivery
Secondary	Adverse events (somnolence, dizziness, nausea, depression, suicidal ideation, or notable peripheral edema) or drug reactions		one week after cesarean delivery