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OpenTrials
Active, Not Recruiting

NCT Number: NCT04240626

Multimodal Analgesia Effect on Post Surgical Patient

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity, Morbid Agnosia Bariatric Surgery Candidate Body Weight Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Surgery

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UC Davis Health

Sacramento, California, 95817, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

neurontin

Drug

600 mg on-call prior to surgery, post surgery 100 mg liquid q 8-12 hours post surgery with Tylenol every 6 hours

Other names: Gabapentin

Dilaudid Injectable Product

Drug

.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

Other names: Hydromorphone

Marcaine Injectable Product

Drug

0.25% local injectable anesthetic agent infiltrated at all laparoscopic incision sites for both groups.

Oxycodone hydrochloride

Drug

1 mg/ml oral solution, dosage 5-10mg q4h prn for pain control

Hycet 7.5Mg-325Mg/15Ml Solution

Drug

Dosage: 10-15ml q4h prn for pain control

Other names: Hydrocodone

Zofran Injection

Drug

4 mg IV for nausea control while inpatient, prn

Other names: Odanesetron

scopolamine patch

Drug

Topical application patch for nausea control, used with/without Ativan.

Other names: Scopolamine

Ativan

Drug

0.5mg IV as needed in conjunction with/without Scopolamine and Zofran for Nausea control

Flexeril Oral Product

Drug

5 mg orally q8h prn for muscle spasms.

Other names: Cyclobenziparin

Tylenol Suspension

Drug

1000 mg q6h PRN for pain control.

Other names: Acetaminophen

Primary outcomes

  1. Change In Post Operative Pain Intensity

    Time frame: 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

  2. Change in Oral Morphine Equivalence (OME) from 3 days and 14 days post surgery

    Time frame: 3 Days and 14 Days Post Surgery

    OME Table is used to measure opioid use post surgery

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2020
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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