Opioid Free Anesthesia vs. Opioid Anesthesia Techniques.

Phase 2

• Conditions: Analgesic Drug Dependence; Colectomy
• Interventions: Drug: Opioid-free Anesthesia; Drug: Opioid Anesthesia

• Registration Number: NCT03367988
• Lead Sponsor: University of South Florida

Brief Summary

A comparison of post-operative opioid use in Laparoscopic Colectomy patients receiving Opioid or Opioid-free Anesthesia.

Detailed Description

The study population will be composed of 100 patients total, 50 opioid-free anesthesia laparoscopic colectomy patients and 50 opioid anesthesia laparoscopic colectomy patients at Tampa General Hospital. After consent is obtained patients will be electronically randomized using REDCap in a 1:1 ratio and assigned to a opioid anesthesia or opioid free anesthesia group. Patients will also consent to be asked survey questions preoperatively and be followed for 12 months postoperatively at specific intervals to evaluate pain, satisfaction, and opioid prescription use. This will be done through a data mining platform and service known as REDCap. REDCap is partnered with USF to allow for subject management, data collection and the distribution of surveys via mobile phone. All data collected by REDCap is stored on a HIPPA compliant server. Patients will receive automated push notifications to their mobile phones to fill out surveys regarding their pill usage, pain, and satisfaction for a year or until cessation of opioid use is confirmed. Confirmation of opioid cessation will be performed on a case by case basis by the principal investigator, Dr. Camporesi. In addition to the surveys performed, nausea and pain scores will be collected prospectively from observation in the PACU

Study Timeline

• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-11
• Study Start: 2018-12-01
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-25
• Primary Completion: 2023-01
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients admitted to TGH for laparoscopic colectomy under Dr. Sanchez's care
• Adults aged 18 and older

Exclusion Criteria

• Patients who are pregnant
• Patients that are not registered within Tampa General Hospital Electronic Medical Records System
• Patients without smart phone capabilities
• Patients younger than 18 years
• Patients older than 80 years
• Patients who cannot speak or read English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid-free Anesthesia	Opioid-free Anesthesia	Patients will receive no intraoperative narcotics as part of their anesthesia regimen
Opioid Anesthesia	Opioid Anesthesia	Patients will receive intraoperative narcotics as part of their anesthesia regimen

Primary Outcome Measures

Name	Time	Method
Brief Pain Inventory	Once a week for up to 12 months	a standardized 9 question survey broken into pain severity and pain interference sections. The sections rank various items relating to their respective categorizations of pain on a scale from 0 to 10. The arithmetic mean of each section can then be utilized to determine Severity of pain and impact of pain on daily function during the past week.
Post-surgical opioid prescription use, # of pills used per week	Once a week for up to 12 months	Weekly pill use for pain management upon discharge

Secondary Outcome Measures

Name	Time	Method
PACU: Pain Scores	1 - 3 hours	Visual Analogue Scale (VAS) pain scores every 15 minutes on a 10 centimeter scale. Using a ruler, the score is determined by measuring the distance (cm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity. no pain (0 cm), mild pain(1-4.4 cm), moderate pain (4.5-7.4 cm), and severe pain (7.5-10 cm). Normative values are not available. The scale has to be shown to the patient otherwise it is an auditory scale not a visual one.
PACU: Nausea Scores	1 - 3 hours	Postoperative Nausea and Vomiting (PONV) every 15 minutes scores (0-4) 0, no nausea; 1, mild nausea ≤ 15 minutes; 2, nausea ≥ 10 minutes; 3, nausea ≥ 5 minutes; 4, vomiting
PACU: Opioid Use in Morphine Equivalents	1 - 3 hours	Total ammount of rescue narcotics used in PACU converted to milligram morphine equivalents using CDC guidelines for prescribing Opioids
Patient Satisfaction	12 months	Patient treatment satisfaction survey results
Length of Stay	1- 5 days	Total length of hospital stay in hours

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States