NCT04240626

Multimodal Analgesia Effect on Post Surgical Patient

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: Female
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Obesity, Morbid
• Surgery
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
DRUG	Neurontin	600 mg on-call prior to surgery, post surgery 100 mg liquid q 8-12 hours post surgery with Tylenol every 6 hours
DRUG	Dilaudid Injectable Product	.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
DRUG	Marcaine Injectable Product	0.25% local injectable anesthetic agent infiltrated at all laparoscopic incision sites for both groups.
DRUG	Oxycodone Hydrochloride	1 mg/ml oral solution, dosage 5-10mg q4h prn for pain control
DRUG	Hycet 7.5Mg-325Mg/15Ml Solution	Dosage: 10-15ml q4h prn for pain control
DRUG	Zofran Injection	4 mg IV for nausea control while inpatient, prn
DRUG	Scopolamine patch	Topical application patch for nausea control, used with/without Ativan.
DRUG	Ativan	0.5mg IV as needed in conjunction with/without Scopolamine and Zofran for Nausea control
DRUG	Flexeril Oral Product	5 mg orally q8h prn for muscle spasms.
DRUG	Tylenol Suspension	1000 mg q6h PRN for pain control.

Timeline

• Start date: 2021-01-20
• Primary completion: 2026-06-24
• Completion: 2026-06-24
• First posted: 2020-01-27
• Last updated: 2025-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study