Multimodal Analgesia Effect on Post Surgical Patient

NCT04240626 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: 1452523
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity, Morbid; Surgery; Bariatric Surgery Candidate

Keywords

Bariatric Surgery,; Pain Control; Gabapentinin

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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; 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

Multi-Modal

EXPERIMENTAL

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; 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

Interventions

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

Also known as: Gabapentin

Multi-Modal

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

Also known as: Hydromorphone

Multi-Modal; Standard of Care

Marcaine Injectable Product DRUG

0.25% local injectable anesthetic agent infiltrated at all laparoscopic incision sites for both groups.

Multi-Modal; Standard of Care

Oxycodone Hydrochloride DRUG

1 mg/ml oral solution, dosage 5-10mg q4h prn for pain control

Multi-Modal; Standard of Care

Hycet 7.5Mg-325Mg/15Ml Solution DRUG

Dosage: 10-15ml q4h prn for pain control

Also known as: Hydrocodone

Multi-Modal; Standard of Care

Zofran Injection DRUG

4 mg IV for nausea control while inpatient, prn

Also known as: Odanesetron

Multi-Modal; Standard of Care

Scopolamine patch DRUG

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

Also known as: Scopolamine

Multi-Modal; Standard of Care

Ativan DRUG

0.5mg IV as needed in conjunction with/without Scopolamine and Zofran for Nausea control

Multi-Modal; Standard of Care

Flexeril Oral Product DRUG

5 mg orally q8h prn for muscle spasms.

Also known as: Cyclobenziparin

Multi-Modal; Standard of Care

Tylenol Suspension DRUG

1000 mg q6h PRN for pain control.

Also known as: Acetaminophen

Multi-Modal

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Health

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Obesity, Morbid; Agnosia

Interventions

Gabapentin; Hydromorphone; Oxycodone; oxycodone-acetaminophen; Hydrocodone; Ondansetron; Scopolamine; Lorazepam; Acetaminophen

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Codeine; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Benzodiazepinones; Benzodiazepines; Benzazepines; Acetanilides; Anilides; Amides; Aniline Compounds

Study Officials

• Mohamed R Ali, MD, FACS

  Professor of Surgery

  PRINCIPAL INVESTIGATOR

• Barbara Jachniewicz, MSN, CRNFA,

  Nurse Practitioner, Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: January 27, 2020
• Study Start: January 20, 2021
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): June 24, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)