Multimodal Analgesia Effect on Post Surgical Patient

August 7, 2023 updated by: University of California, Davis
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
The group will receive the standard of care pain control protocol after index Bariatric Surgery which includes the use of a PCA (patient controlled analgesia) with Dilaudid or Morphine Sulphate, transitioning to oral narcotic based pain control medications.
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
Other Names:
  • Hydromorphone
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
Other Names:
  • Hydrocodone
Drug: Zofran Injection
4 mg IV for nausea control while inpatient, prn
Other Names:
  • Odanesetron
Drug: Scopolamine patch
Topical application patch for nausea control, used with/without Ativan.
Other Names:
  • Scopolamine
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.
Other Names:
  • Cyclobenziparin
Experimental: Multi-Modal
Patients will receive Gabapentin pre-operatively on-call 120 minutes prior to surgery starting. Patients at the conclusion of surgery will have additional doses of Ofirmev (IV Tylenol) and Gabapentin via IV based on patients pre-operative weight. Post surgery the patient will be transitioned to oral pain medications (Tylenol and Gabapentin) with rescue medications available for breakthrough pain control.
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
Other Names:
  • Hydromorphone
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
Other Names:
  • Hydrocodone
Drug: Zofran Injection
4 mg IV for nausea control while inpatient, prn
Other Names:
  • Odanesetron
Drug: Scopolamine patch
Topical application patch for nausea control, used with/without Ativan.
Other Names:
  • Scopolamine
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.
Other Names:
  • Cyclobenziparin
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
Other Names:
  • Gabapentin
Drug: Tylenol Suspension
1000 mg q6h PRN for pain control.
Other Names:
  • Acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 Days and 14 Days Post Surgery
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
3 Days and 14 Days Post Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Mohamed R Ali, MD, FACS, Professor of Surgery
  • Principal Investigator: Barbara Jachniewicz, MSN, CRNFA,, Nurse Practitioner, Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 16, 2019

First Submitted That Met QC Criteria

January 21, 2020

First Posted (Actual)

January 27, 2020

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1452523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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