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Completed

NCT Number: NCT05494385

Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative Gabapentin/Postoperative Placebo

Drug

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

Drug

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.

Primary outcomes

  1. Opioid Prescription at Discharge

    Time frame: Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery)

    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.

Secondary outcomes

  1. Opioid Refill Requests

    Time frame: 6 weeks

    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.

  2. Inpatient Pain Scores

    Time frame: Length of postoperative hospital stay (an average of 32 hours following surgery)

    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. Highest pain score recorded.

  3. Inpatient Morphine Milligram Equivalents

    Time frame: Length of postoperative hospital stay (an average of 32 hours following surgery)

    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.

  4. Length of Stay

    Time frame: Time of registration for surgery to time of discharge from hospital

    Length of stay will be measured in hours by time of registration for surgery to time of discharge from hospital.

  5. Nausea

    Time frame: Length of postoperative hospital stay (an average of 32 hours following surgery)

    Nausea will be measured by the number of "as needed" antiemetics the patient received postoperatively.

  6. Sedation

    Time frame: On postoperative day 1 between 6AM and 10AM

    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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 10, 2022
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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