Pain Management Study

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
University of Arizona
Study ID
NCT05231460
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Pain, Postoperative

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active Comparator: narcotic regimen with TAP block — DRUG
    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
  • Active Comparator: narcotic regimen with no TAP block — DRUG
    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
  • non-narcotic regimen with TAP block — DRUG
    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
  • non-narcotic regimen with no TAP block — DRUG
    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

Study Details

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.

Key Dates

Start date
Feb 18, 2022
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
244 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: narcotic regimen with TAP block
    Patient will receive Tap Block and will be administered the Narcotic Pain Regimen post-operatively
  • Active Comparator: narcotic regimen with no TAP block
    Patient will not receive TAP block and will be administered the Narcotic Pain Regimen post-operatively
  • Active Comparator: non-narcotic regimen with TAP block
    Patient will receive Tap Block and will be administered Non-narcotic Pain Regimen post-operatively
  • Active Comparator: non-narcotic regimen with no TAP block
    Patient will not receive TAP block and will be administered Non-narcotic Pain Regimen post-operatively

Primary Outcome Measure

postoperative pain [ Time Frame: discharge or 24 hours postoperative, whichever is first ]

Locations (1)

FacilityCityStateZIPSite coordinators
Banner University Medical Center PhoenixPhoenixArizona85006-

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By research site
Banner University Medical Center Phoenix· Phoenix, AZ

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