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Multimodal Analgesia Effect on Post Surgical Patient

Primary Purpose

Obesity, Morbid, Surgery, Bariatric Surgery Candidate

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Neurontin
Dilaudid Injectable Product
Marcaine Injectable Product
Oxycodone Hydrochloride
Hycet 7.5Mg-325Mg/15Ml Solution
Zofran Injection
Scopolamine patch
Ativan
Flexeril Oral Product
Tylenol Suspension
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring Bariatric Surgery,, Pain Control, Gabapentinin

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UC Davis HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Multi-Modal

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
Change in Oral Morphine Equivalence (OME) from 3 days and 14 days post surgery
OME Table is used to measure opioid use post surgery

Secondary Outcome Measures

Full Information

First Posted
October 16, 2019
Last Updated
August 7, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT04240626
Brief Title
Multimodal Analgesia Effect on Post Surgical Patient
Official Title
Multimodal Analgesia Effect on Post Surgical Patient
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid, Surgery, Bariatric Surgery Candidate
Keywords
Bariatric Surgery,, Pain Control, Gabapentinin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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 control
Masking
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Multi-Modal
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Neurontin
Other Intervention Name(s)
Gabapentin
Intervention Description
600 mg on-call prior to surgery, post surgery 100 mg liquid q 8-12 hours post surgery with Tylenol every 6 hours
Intervention Type
Drug
Intervention Name(s)
Dilaudid Injectable Product
Other Intervention Name(s)
Hydromorphone
Intervention Description
.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
Intervention Type
Drug
Intervention Name(s)
Marcaine Injectable Product
Intervention Description
0.25% local injectable anesthetic agent infiltrated at all laparoscopic incision sites for both groups.
Intervention Type
Drug
Intervention Name(s)
Oxycodone Hydrochloride
Intervention Description
1 mg/ml oral solution, dosage 5-10mg q4h prn for pain control
Intervention Type
Drug
Intervention Name(s)
Hycet 7.5Mg-325Mg/15Ml Solution
Other Intervention Name(s)
Hydrocodone
Intervention Description
Dosage: 10-15ml q4h prn for pain control
Intervention Type
Drug
Intervention Name(s)
Zofran Injection
Other Intervention Name(s)
Odanesetron
Intervention Description
4 mg IV for nausea control while inpatient, prn
Intervention Type
Drug
Intervention Name(s)
Scopolamine patch
Other Intervention Name(s)
Scopolamine
Intervention Description
Topical application patch for nausea control, used with/without Ativan.
Intervention Type
Drug
Intervention Name(s)
Ativan
Intervention Description
0.5mg IV as needed in conjunction with/without Scopolamine and Zofran for Nausea control
Intervention Type
Drug
Intervention Name(s)
Flexeril Oral Product
Other Intervention Name(s)
Cyclobenziparin
Intervention Description
5 mg orally q8h prn for muscle spasms.
Intervention Type
Drug
Intervention Name(s)
Tylenol Suspension
Other Intervention Name(s)
Acetaminophen
Intervention Description
1000 mg q6h PRN for pain control.
Primary Outcome Measure Information:
Title
Change In Post Operative Pain Intensity
Description
Using the Wong-Baker Pain Rating Scale-0=No Pain, 2-4, Slight Pain, 6-8, Moderate Pain, 9-10, Severe Pain
Time Frame
3 Days and 14 Days Post Surgery
Title
Change in Oral Morphine Equivalence (OME) from 3 days and 14 days post surgery
Description
OME Table is used to measure opioid use post surgery
Time Frame
3 Days and 14 Days Post Surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William Smith, BS, CCRP
Phone
916-734-7820
Email
whsmith@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed R Ali, MD, FACS
Organizational Affiliation
Professor of Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Jachniewicz, MSN, CRNFA,
Organizational Affiliation
Nurse Practitioner, Department of Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Smith
Phone
916-734-7820
Email
whsmith@ucdavis.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Multimodal Analgesia Effect on Post Surgical Patient

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