Clinical trial

Multimodal Analgesia Effect on Post Surgical Patient

Active, not recruiting · Phase 4 · 1 countries · Registry ID NCT04240626

Active, not recruitingPhase 4Interventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age35 Years to 65 Years

SexFemale

Healthy volunteersNot accepted

ConditionObesity, Morbid, Surgery, Bariatric Surgery Candidate

Full registry 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

Treatments and study arms

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

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

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

Zofran Injection

Drug

4 mg IV for nausea control while inpatient, prn

Scopolamine patch

Drug

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

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.

Tylenol Suspension

Drug

1000 mg q6h PRN for pain control.

Primary outcomes

Change In Post Operative Pain Intensity3 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

Change in Oral Morphine Equivalence (OME) from 3 days and 14 days post surgery3 Days and 14 Days Post Surgery

OME Table is used to measure opioid use post surgery

Study locations

1 locations were listed when this page was built. The first 40 are shown.

UC Davis Health🇺🇸 Sacramento, California, United States

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