Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

Postoperative Pain Clinical Trial

Official title:

Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05494385
• Other study ID #: OBGYN-IIR-PERI-OP-GABAPENTIN
• Status: Completed
• Phase: Phase 4
• Start date: July 27, 2021
• Est. completion date: July 5, 2023

Study information

• Verified date: July 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 5, 2023
• Est. primary completion date: June 17, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women > 18 years old

• English-speaking

• Stage > 2 pelvic organ prolapse

• Undergoing pelvic organ prolapse procedure (including native tissue vaginal procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic procedure, obliterative procedure)

• Planning overnight stay

Exclusion Criteria:

• Renal dysfunction (creatinine clearance <60 mL/min)

• Allergy to acetaminophen and ibuprofen

• Allergy to gabapentin

• Patients on a Controlled Substance Agreement or Opioid Contract from another provider. This information is available in the IU Health electronic medical record, Cerner.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Preoperative Gabapentin/Postoperative Placebo
Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to placebo every 12 hours. The placebo is encapsulated to appear identical to the active drug. This group will have oxycodone 5 mg every 6 hours as needed for pain.
• Preoperative Gabapentin/Postoperative Gabapentin
Postoperatively, this group will receive scheduled acetaminophen and ibuprofen every 6 hours, in addition to gabapentin every 12 hours. The gabapentin is encapsulated to appear identical to the placebo. This group will have oxycodone 5 mg every 6 hours as needed for pain.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	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	Opioid Prescription at Discharge	Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids.	Length of postoperative hospital stay (typically less than 48 hours)
Secondary	Opioid Refill Requests	Number of patients in each group who call the office to request a new opioid prescription (if they were discharged without a prescription) or to request an opioid prescription refill (if they were discharged with a prescription) within the 6-week postoperative time period.	6 weeks
Secondary	Inpatient Pain Scores	Pain scores in the hospital will be measured on a numeric rating scale (0-10) with 0 being no pain and 10 being worst pain. Pain score collected will be pain recorded at 12 hours after arrival to the floor and highest score during hospital stay	Length of postoperative hospital stay (typically less than 48 hours)
Secondary	Inpatient Morphine Milligram Equivalents	Total morphine milligram equivalents used will be calculated by converting total PO and IV opioids used postoperatively until hospital discharge to morphine milligram equivalents using the opioid equianalgesic chart.	Length of postoperative hospital stay (typically less than 48 hours)
Secondary	Length of Stay	Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital.	Length of postoperative hospital stay (typically less than 48 hours)
Secondary	Nausea	Nausea will be measured by the number of "as needed" antiemetics the patient received postoperatively.	Length of postoperative hospital stay (typically less than 48 hours)
Secondary	Sedation	Sedation will be measured by the Stanford Sleepiness Scale. This is a self-administered scale that the patient will complete at 10AM on postoperative day 1.	Length of postoperative hospital stay (typically less than 48 hours)