Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bariatric Surgery Candidate
  • Obesity Morbid
  • Surgery
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 controlMasking: None (Open Label)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.Primary Purpose: Treatment

Participation Requirements

Age
Between 35 years and 65 years
Gender
Only males

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...

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).

Tracking Information

NCT #
NCT04240626
Collaborators
Not Provided
Investigators
Principal Investigator: Mohamed R Ali, MD, FACS Professor of Surgery Principal Investigator: Barbara Jachniewicz, MSN, CRNFA, Nurse Practitioner, Department of Surgery