Multimodal Analgesia Effect on Post Surgical Patient

Surgery Clinical Trial

Official title:

Multimodal Analgesia Effect on Post Surgical Patient

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04240626
• Other study ID #: 1452523
• Status: Recruiting
• Phase: Phase 4
• Start date: January 20, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: University of California, Davis
• Contact: William Smith, BS, CCRP
• Phone: 916-734-7820
• Email: whsmith[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity, Morbid
• Surgery

Intervention

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
• 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
• Marcaine Injectable Product
0.25% local injectable anesthetic agent infiltrated at all laparoscopic incision sites for both groups.
• Oxycodone Hydrochloride
1 mg/ml oral solution, dosage 5-10mg q4h prn for pain control
• Hycet 7.5Mg-325Mg/15Ml Solution
Dosage: 10-15ml q4h prn for pain control
• Zofran Injection
4 mg IV for nausea control while inpatient, prn
• Scopolamine patch
Topical application patch for nausea control, used with/without Ativan.
• Ativan
0.5mg IV as needed in conjunction with/without Scopolamine and Zofran for Nausea control
• Flexeril Oral Product
5 mg orally q8h prn for muscle spasms.
• Tylenol Suspension
1000 mg q6h PRN for pain control.

Locations

Country	Name	City	State
United States	UC Davis Health	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change In Post Operative Pain Intensity	Using the Wong-Baker Pain Rating Scale-0=No Pain, 2-4, Slight Pain, 6-8, Moderate Pain, 9-10, Severe Pain	3 Days and 14 Days Post Surgery
Primary	Change in Oral Morphine Equivalence (OME) from 3 days and 14 days post surgery	OME Table is used to measure opioid use post surgery	3 Days and 14 Days Post Surgery