Obesity, Morbid, Surgery, Bariatric Surgery Candidate
Conditions
Keywords
Bariatric Surgery,, Pain Control, Gabapentinin
Brief 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
Detailed description
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).
Interventions
DRUGNeurontin
600 mg on-call prior to surgery, post surgery 100 mg liquid q 8-12 hours post surgery with Tylenol every 6 hours
.5-1 mg IV Q3 hours and IV Tylenol 1000mg every 6 hours post surgery transitioning to oral pain control medications (Hycet 7.5/325mg/5 ml, 5-10 ml every 4 hours
0.25% local injectable anesthetic agent infiltrated at all laparoscopic incision sites for both groups.
1 mg/ml oral solution, dosage 5-10mg q4h prn for pain control
DRUGHycet 7.5Mg-325Mg/15Ml Solution
Dosage: 10-15ml q4h prn for pain control
DRUGZofran Injection
4 mg IV for nausea control while inpatient, prn
Topical application patch for nausea control, used with/without Ativan.
DRUGAtivan
0.5mg IV as needed in conjunction with/without Scopolamine and Zofran for Nausea control
DRUGFlexeril Oral Product
5 mg orally q8h prn for muscle spasms.
DRUGTylenol Suspension
1000 mg q6h PRN for pain control.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients agreeing to participate in the study will be assigned one of two treatment arms. Neither the care team nor the patient will be masked.
Intervention model description
Patients will receive Gabapentin and Ofirmev post surgery (dosage based on patients pre-operative weight) with on-call medications as needed including narcotic analgesia for breakthrough pain control
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change In Post Operative Pain Intensity | 3 Days and 14 Days Post Surgery | Using the Wong-Baker Pain Rating Scale-0=No Pain, 2-4, Slight Pain, 6-8, Moderate Pain, 9-10, Severe Pain |
| Change in Oral Morphine Equivalence (OME) from 3 days and 14 days post surgery | 3 Days and 14 Days Post Surgery | OME Table is used to measure opioid use post surgery |
Countries
United States
Outcome results
None listed