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Pain Management Study

NCT05231460 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2025-08-24

No results posted yet for this study

Summary

This study aims to better understand the role that narcotic vs. non-narcotic multimodal pain management play in patients' pain following bariatric surgery (Laproscopic Surgery and Robotic Assisted Surgery). Participation in this study will last approximately 90 days following surgery. During that 90 day period, participants will be asked to report pain and nausea every 4 hours to a study coordinator or nurse while they are recovering in the hospital. Following discharge from the hospital patients will be asked to report pain, nausea, and any medical changes 7 days, 30 days, and 90 days from surgical date.

The procedures and medications used in this study are FDA approved medical therapies and are part of Standard of Care for this population. This study aims to therapeutically investigate efficacy of the proposed pain management regimens. The procedures and individual medications are not the subject of research as they are considered routine well established and documented interventions for obesity and the treatment of post operative pain.

Conditions

  • Pain, Postoperative

Interventions

DRUG

Active Comparator: narcotic regimen with TAP block

Patient will receive Tap Block to 15ml of 0.5% Ropivacaine and will be administered the following Narcotic Pain Regimen post-operatively: * PO Oxycodone 5mg, 10mg q4h for moderate and severe pain * IV Dilaudid 1mg q3h for breakthrough pain

DRUG

Active Comparator: narcotic regimen with no TAP block

Patient will not receive TAP block and will be administered the following Narcotic Pain Regimen post-operatively: * PO Oxycodone 5mg, 10mg q4h for moderate and severe pain * IV Dilaudid 1mg q3h for breakthrough pain

DRUG

non-narcotic regimen with TAP block

Patient will receive Tap Block to 15ml of 0.5% Ropivacaine and will be administered the following Non-narcotic Pain Regimen post-operatively: * Toradol 15mg q6h * Tylenol 1000mg q8h * Gabapentin 100mg three times a day

DRUG

non-narcotic regimen with no TAP block

Patient will not receive TAP block and will be administered the following Non-narcotic Pain Regimen post-operatively: * Toradol 15mg q6h * Tylenol 1000mg q8h * Gabapentin 100mg three times a day

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-18
Primary Completion
2026-06-30
Completion
2026-06-30
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 NCT05231460 on ClinicalTrials.gov