Summary

Eligibility
for females ages 35-65 (full criteria)
Dates
study started
estimated completion

Description

Summary

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

Official Title

Multimodal Analgesia Effect on Post Surgical Patient

Details

Pain control after weight loss surgery is challenging due to the alteration of digestive system anatomy and limitation on using medications which can either be crushed or in liquid form for the first 10 days to 14 days after surgery. Additionally there are multiple programs in place to eliminate the use of narcotic/opioid based pain medications due their potential addictive risks.

This study compares two groups of patients whom will have Roux en Y Gastric Bypass Surgery at UC Davis Medical Center, the control group will receive standard of care pain control medications (including opioid based medications) compared to the research arm, this group will receive Gabapentinin and Tylenol for pain control after surgery with rescue pain medications available if needed.

Post surgery both groups will be managed by the Bariatric Surgery Team and will be contacted periodically as part of the standard of care to monitor pain control and usage of any rescue medications (if needed).

Keywords

Obesity, Morbid Surgery Bariatric Surgery Candidate Bariatric Surgery, Pain Control Gabapentinin Acetaminophen Scopolamine Oxycodone Gabapentin Hydromorphone Hydrocodone Bupivacaine Cyclobenzaprine Butylscopolammonium Bromide Neurontin Dilaudid Injectable Product Marcaine Injectable Product Oxycodone Hydrochloride Hycet 7.5Mg-325Mg/15Ml Solution Zofran Injection Scopolamine patch Ativan Flexeril Oral Product Tylenol Suspension Multi-Modal

Eligibility

You can join if…

Open to females ages 35-65

  • 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

You CAN'T join if...

  • 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
Links
Sign up for this study
ID
NCT04240626
Study Type
Interventional
Last Updated