Pain Management Study

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Active Comparator: narcotic regimen with TAP block; Drug: Active Comparator: narcotic regimen with no TAP block; Drug: non-narcotic regimen with TAP block; Drug: non-narcotic regimen with no TAP block

Detailed Description

The majority of patients who undergo surgery will require treatment for the management of acute post-surgical pain. The use of narcotics after elective surgical procedures has contributed to the current opioid epidemic. Striking the right balance of treatment and use of narcotics vs. non-narcotic medications is at a crucial juncture in surgery.

Post-surgical pain influences a patient's perception of quality of care, physical recovery, and length of stay. The threat of poor postoperative pain control is a fear of many patients who will have a surgical procedure. The post- operative pain regimen is traditionally chosen by the operating surgeon rather than in a shared decision-making model where patients are educated about choice and participate in management. This is one of many factors influencing use of medications for post-operative pain. If a patient develops longer term, chronic postsurgical pain it may lead to disability and diminish quality of life, increase healthcare utilization, increase healthcare costs, and result in loss of productivity.

Morbid obesity is a global epidemic that increases the risk of developing related complications such as cardiac failure, type 2 diabetes, hypertension, hyperlipidemia, degenerative joint disease with the development of chronic pain and decreased mobility, and sleep apnea. In 2013 and 2014, 50% of the population had or had been affected by obesity, defined as a BMI ≥30mg/kg2. An established and effective treatment for weight loss is elective bariatric surgery.

Laparoscopic bariatric surgery (>90% of cases) is associated with less postoperative pain than open surgery, however, opioids are still used frequently for analgesia. Opioid analgesia comes with many side effects including nausea, constipation, risk of postoperative ileus, hypopnea, hypoxemia, delayed ambulation and mortality. This patient population is at increased risk for hypoventilation and narcotic related post-operative complications.

In the BUMCP department of bariatric surgery, we began employing a post-operative multimodal pain control protocol in November of 2017 and noticed improvement in pain control, declining levels of nausea and a decrease in the length of stay with our patient population. All medications and surgical interventions are considered approved standard of care in surgery. Previous studies have shown that employing a multimodal pain control protocol, even intraoperatively, influences postoperative pain control, nausea, emesis as well as chronic postoperative pain. In mid-2018 we began offering patients tap blocks which we believe have offered patients more consistent post- operative pain control.

Postsurgical pain control is imperative as it influences a patient's quality of care and life, recovery, and length of stay. Poor pain control can not only lead to increased healthcare utilization/costs, whereas use of opioid analgesia comes with side effects including nausea, constipation, risk of postoperative ileus, hypopnea, hypoxemia, delayed ambulation, mortality, and the increased possibility of long-term narcotic addiction. In the population that suffers from obesity it is desirable to reduce the narcotics being used as they are at increased risk for hypoventilation and post-operative complications. The BUMCP bariatric surgery department began employing a post-operative multimodal pain control protocol and noticed improvement in pain control, a decrease in perioperative morbidity from narcotic use and a decreased length of stay in the elective patient population undergoing primary bariatric surgery. This study will contribute to our knowledge of whether a non-narcotic, multi-modal post-operative pain management protocol is equivalent, if not superior in multiple facets compared to narcotic use.

Objectives

Study Hypothesis:

The use of a multi-modal, non-narcotic pain management regimen in postoperative bariatric patients will have equivalent, if not superior, postoperative outcomes compared with patient receiving narcotic pain management regimen. Those patients receiving a TAP block will have better pain control in the first 24 hours post-op.

Primary outcome measure:

Patient reported postoperative pain using the Wong Baker Faces pain scale (mean of all reported scores till the earlier of discharge and 24 hours postoperative).

Secondary outcomes measures:

• Postoperative nausea numerical rating scale (0-5)
• Length of time before subject can complete 200 feet of ambulation post-op
• Hospital length of stay
• Readmissions for pain control up to 30-day postoperatively (as binary Yes/No and also as a count variable)

• Study Type: Interventional
• Enrollment (Estimated): 244
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Anna Valencia; Phone Number: 520-780-8241; Email: atvalencia@arizona.edu

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner University Medical Center Phoenix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: narcotic regimen with TAP block; Patient will receive Tap Block and will be administered the Narcotic Pain Regimen post-operatively	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
Active Comparator: narcotic regimen with no TAP block; 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; 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
Active Comparator: non-narcotic regimen with TAP block; Patient will receive Tap Block and will be administered Non-narcotic Pain Regimen post-operatively	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
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea	Postoperative nausea defined by numerical rating scale (0-5)	post-operative until patient discharge or up to 90 days, whichever comes first
200 foot ambulation	Length of time before subject can complete 200 feet of ambulation post-op	post-operative until patient discharge or up to 90 days, whichever comes first
Hospital length of stay	Patient's length of stay in the hospital	post-operative until patient discharge or up to 90 days, whichever comes first
Readmissions	Readmissions for pain control	up to 30-day postoperatively

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 21, 2021
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): February 9, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Bariatric Surgery; Postoperative Complications; Sleeve gastrectomy; Transversus Abdominis Plane (TAP) Block; Pain, post-operative; Analgesics, Non-Narcotic; Analgesics, Narcotic; Gastric Sleeve
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics
• Other Study ID Numbers: 2108122253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be retained for future use. Data will not be shared with collaborating entities nor sold/shared with pharmaceutical companies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes