Multimodal Analgesia Effect on Post Surgical Patient

University of California (UC) Davis

Status and phase: Enrolling; Phase 4

Conditions: Surgery; Bariatric Surgery Candidate; Obesity, Morbid

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04240626

1452523

Details and patient eligibility

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

Full 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).

Enrollment: 60 estimated patients

Sex: Female

Ages: 35 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Standard of Care

Active Comparator group

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.

Treatment:

Drug: Ativan

Drug: Marcaine Injectable Product

Drug: Dilaudid Injectable Product

Drug: Hycet 7.5Mg-325Mg/15Ml Solution

Drug: Scopolamine patch

Drug: Zofran Injection

Drug: Oxycodone Hydrochloride

Drug: Flexeril Oral Product

Multi-Modal

Experimental group

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.

Treatment:

Drug: Neurontin

Drug: Ativan

Drug: Marcaine Injectable Product

Drug: Dilaudid Injectable Product

Drug: Hycet 7.5Mg-325Mg/15Ml Solution

Drug: Scopolamine patch

Drug: Zofran Injection

Drug: Tylenol Suspension

Drug: Oxycodone Hydrochloride

Drug: Flexeril Oral Product