Multimodal Analgesia Effect on Post Surgical Patient

Study Overview
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Brief Summary
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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
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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).

Official Title
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Multimodal Analgesia Effect on Post Surgical Patient

Conditions
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Obesity, Morbid, Surgery, Bariatric Surgery Candidate

Intervention / Treatment
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* Drug: Neurontin
* Drug: Dilaudid Injectable Product
* Drug: Marcaine Injectable Product
* Drug: Oxycodone Hydrochloride
* Drug: Hycet 7.5Mg-325Mg/15Ml Solution
* Drug: Zofran Injection
* Drug: Scopolamine patch
* Drug: Ativan
* Drug: Flexeril Oral Product
* Drug: Tylenol Suspension


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>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<br>* .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<br>* Other names: Hydromorphone;Drug: Marcaine Injectable Product<br>* 0.25% local injectable anesthetic agent infiltrated at all laparoscopic incision sites for both groups.<br>Drug: Oxycodone Hydrochloride<br>* 1 mg/ml oral solution, dosage 5-10mg q4h prn for pain control<br>Drug: Hycet 7.5Mg-325Mg/15Ml Solution<br>* Dosage: 10-15ml q4h prn for pain control<br>* Other names: Hydrocodone;Drug: Zofran Injection<br>* 4 mg IV for nausea control while inpatient, prn<br>* Other names: Odanesetron;Drug: Scopolamine patch<br>* Topical application patch for nausea control, used with/without Ativan.<br>* Other names: Scopolamine;Drug: Ativan<br>* 0.5mg IV as needed in conjunction with/without Scopolamine and Zofran for Nausea control<br>Drug: Flexeril Oral Product<br>* 5 mg orally q8h prn for muscle spasms.<br>* Other names: Cyclobenziparin;|
| Experimental: Multi-Modal<br>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: Neurontin<br>* 600 mg on-call prior to surgery, post surgery 100 mg liquid q 8-12 hours post surgery with Tylenol every 6 hours<br>* Other names: Gabapentin;Drug: Dilaudid Injectable Product<br>* .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<br>* Other names: Hydromorphone;Drug: Marcaine Injectable Product<br>* 0.25% local injectable anesthetic agent infiltrated at all laparoscopic incision sites for both groups.<br>Drug: Oxycodone Hydrochloride<br>* 1 mg/ml oral solution, dosage 5-10mg q4h prn for pain control<br>Drug: Hycet 7.5Mg-325Mg/15Ml Solution<br>* Dosage: 10-15ml q4h prn for pain control<br>* Other names: Hydrocodone;Drug: Zofran Injection<br>* 4 mg IV for nausea control while inpatient, prn<br>* Other names: Odanesetron;Drug: Scopolamine patch<br>* Topical application patch for nausea control, used with/without Ativan.<br>* Other names: Scopolamine;Drug: Ativan<br>* 0.5mg IV as needed in conjunction with/without Scopolamine and Zofran for Nausea control<br>Drug: Flexeril Oral Product<br>* 5 mg orally q8h prn for muscle spasms.<br>* Other names: Cyclobenziparin;Drug: Tylenol Suspension<br>* 1000 mg q6h PRN for pain control.<br>* Other names: Acetaminophen;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bariatric Surgery,, Pain Control, Gabapentinin