Do Experience of Pain and 30-Day Surgery Outcomes Differ in Robotic Bariatric Surgery Patients Treated With Narcotic vs. Non-narcotic Pain Management Protocols?

2108122253

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.

2022-02-18

2024-06-01

2025-06-01

Early phase I

244

Inclusion Criteria: * Laparoscopic or Robotic Sleeve Gastrectomy bariatric surgery scheduled electively from the BUMCP Bariatric Clinic * BMI\>35kg/m2 * Patient of Principal Investigator or Co-Investigator * 18 years or older Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '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.\n\nThe 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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': '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.'}}, 'enrollmentInfo': {'count': 244, 'type': 'ESTIMATED'}}

2024-02-16