Clinical trial NCT04240626: Multimodal Analgesia Effect on Post Surgical Patient
Official title: Multimodal Analgesia Effect on Post Surgical Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity, Morbid
Surgery
Bariatric Surgery Candidate
Keywords: Bariatric Surgery,
Pain Control
Gabapentinin
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change In Post Operative Pain Intensity
timeFrame: 3 Days and 14 Days Post Surgery
measure: Change in Oral Morphine Equivalence (OME) from 3 days and 14 days post surgery
timeFrame: 3 Days and 14 Days Post Surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Health
state: California
Study officials:
affiliation: Professor of Surgery
name: Mohamed R Ali, MD, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Nurse Practitioner, Department of Surgery
name: Barbara Jachniewicz, MSN, CRNFA,
role: PRINCIPAL_INVESTIGATOR
References: