Multimodal Analgesia Effect on Post Surgical Patient

NCT04240626 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-08

No results posted yet for this study

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

Interventions

DRUG

Neurontin

600 mg on-call prior to surgery, post surgery 100 mg liquid q 8-12 hours post surgery with Tylenol every 6 hours

DRUG

Dilaudid Injectable Product

.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

DRUG

Marcaine Injectable Product

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

DRUG

Oxycodone Hydrochloride

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

DRUG

Hycet 7.5Mg-325Mg/15Ml Solution

Dosage: 10-15ml q4h prn for pain control

DRUG

Zofran Injection

4 mg IV for nausea control while inpatient, prn

DRUG

Scopolamine patch

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

DRUG

Ativan

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

DRUG

Flexeril Oral Product

5 mg orally q8h prn for muscle spasms.

DRUG

Tylenol Suspension

1000 mg q6h PRN for pain control.

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Mohamed R Ali, MD, FACS · Professor of Surgery

  • Barbara Jachniewicz, MSN, CRNFA, · Nurse Practitioner, Department of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2026-06-24
Completion
2026-06-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04240626 on ClinicalTrials.gov