RECRUITING
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Multimodal Analgesia Effect on Post Surgical Patient
Patients undergoing Bariatric Surgery at the University of California Davis Medical Center will be divided into two groups, one receiving Standard of Care pain control medications vs the second group which will receive non-narcotic pain medications with rescue pain medications available if needed
Conditions:
🦠 Obesity, Morbid 🦠 Surgery 🦠 Bariatric Surgery Candidate
🗓️ Study Start (Actual) 20 January 2021
🗓️ Primary Completion (Estimated) 30 December 2024
✅ Study Completion (Estimated) 31 December 2025
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Sacramento, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Women who undergo index weight loss procedures at UC Davis Medical Center
    • * Women with a BMI =\>30
    • * Age from 35-65
    • * American Society of Anesthesiology (ASA) score of 3 or less
    • * No previous history of prior abdominal/foregut surgery

    Exclusion Criteria:

    • * Not having an index weight los surgery for obesity
    • * Do not meet the NIH Standards for weight loss surgery
    • * Additional planned or unplanned procedures during the index surgical procedure such as Cholecystectomy or extensive lysis of adhesions (\>30 minutes)
    • * BMI \< 30
    • * Men
    • * Women considering or currently planning on gender altering/modification
    • * ASA score of 4 or higher
    • * Patients less than 35 years of age or older than 65 years of age at the time of surgical consent
    • * A history of open abdominal surgery including umbilical, ventral, or splengalic hernia repair with or without mesh implantation, transplant or vascular surgery or any foregut procedures including hiatal hernia repair or anti-reflux surgery
    • * Arthritis, Fibromyalgia, chronic pain syndrome
    • * Other conditions requiring daily use of oral pain medications
    • * Prisoners
    • * Allergy to Gabapentin
Ages Eligible for Study: 35 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 October 2019
  • First Submitted that Met QC Criteria 21 January 2020
  • First Posted 27 January 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 August 2023
  • Last Update Posted 9 August 2023
  • Last Verified August 2023
I'm interested ...!!