Pain Management Study

NCT05231460 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 2108122253
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Transversus Abdominis Plane (TAP) Block; Bariatric Surgery; Pain, post-operative; Analgesics, Non-Narcotic; Analgesics, Narcotic; Sleeve gastrectomy; Gastric Sleeve; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  Patient reported postoperative pain using the Wong Baker Faces pain scale. The scale shows a series of six faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable. Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.

  discharge or 24 hours postoperative, whichever is first

Secondary Outcomes (4)

• Postoperative nausea

  post-operative until patient discharge or up to 90 days, whichever comes first

• 200 foot ambulation

  post-operative until patient discharge or up to 90 days, whichever comes first

• Hospital length of stay

  post-operative until patient discharge or up to 90 days, whichever comes first

• Readmissions

  up to 30-day postoperatively

Study Arms (4)

narcotic regimen with TAP block

ACTIVE COMPARATOR

Patient will receive Tap Block and will be administered the Narcotic Pain Regimen post-operatively

Drug: Active Comparator: narcotic regimen with TAP block

narcotic regimen with no TAP block

ACTIVE COMPARATOR

Patient will not receive TAP block and will be administered the Narcotic Pain Regimen post-operatively

Drug: Active Comparator: narcotic regimen with no TAP block

non-narcotic regimen with TAP block

ACTIVE COMPARATOR

Patient will receive Tap Block and will be administered Non-narcotic Pain Regimen post-operatively

Drug: non-narcotic regimen with TAP block

non-narcotic regimen with no TAP block

ACTIVE COMPARATOR

Patient will not receive TAP block and will be administered Non-narcotic Pain Regimen post-operatively

Drug: non-narcotic regimen with no TAP block

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

narcotic regimen with TAP block

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

narcotic regimen with no TAP block

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 TAP block

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

non-narcotic regimen with no TAP block

Eligibility Criteria

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

You may qualify if:

• Laparoscopic or Robotic Sleeve Gastrectomy bariatric surgery scheduled electively from the BUMCP Bariatric Clinic
• BMI\>35kg/m2
• Patient of Principal Investigator or Co-Investigator
• years or older

You may not qualify if:

• Chronic Pain Management on narcotics at New Patient visit or placed on narcotics prior to surgery
• Re-operative bariatric surgery procedures
• Admitted to the ICU after surgery
• Unable to walk 200ft
• Allergic to narcotics, steroids, or other medications used in the protocol
• Use of insulin to treat diabetes
• Chronic Kidney Disease - stage 4 or greater
• Significant hepatic disease
• Carries a diagnosis of Pulmonary Hypertension
• Carries a diagnosis of Congestive Heart Failure
• Pregnant

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Bites and Stings; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Treating surgeon will not be blinded to randomizations. Anesthesiologist providing the Tap Block will be blinded to narcotic arm and unblinded to Tap vs No Tap. Study Coordinator will be blinded to Tap vs No Tap. Statistician will be unblinded to both groups at end of study for final analysis.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Surgery

Model Details: Each subject will be randomized at 1:1 ratio to receive either the Narcotic Pain Regimen or the Non-narcotic Pain Regimen and will also be randomized at 1:1 ratio to receive either TAP block or no TAP block. Eligible subjects will therefore be randomized to one of four arms with approximately equal sizes:1) narcotic regimen with TAP block; 2) narcotic regimen with no TAP block; 3) non-narcotic regimen with TAP block; 4) non-narcotic regimen with no TAP block. The primary comparison will be between narcotic and non-narcotic regimens (arms 1 and 2 combined versus arms 3 and 4 combined). Comparison of TAP block versus no TAP block (arms 1 and 3 combined versus arms 2 and 4 combined) will performed as a secondary analysis.

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: February 9, 2022
• Study Start: February 18, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)