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Opioid-free Anesthesia for Analgesic Dependence (OFA vs OA Trial)

Phase 2 & 3

Recruiting

Led By Enrico Camporesi, MD

Research Sponsored by University of South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

OFA vs OA Trial Summary

This trial looks at whether patients who have surgery for colorectal cancer have less pain and need fewer opioids when they are given opioid-free anesthesia.

Eligible Conditions

Analgesic Drug Dependence
Colectomy

OFA vs OA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brief Pain Inventory

Post-surgical opioid prescription use, # of pills used per week

Secondary outcome measures

Length of Stay

PACU: Nausea Scores

Morphine

+2 more

OFA vs OA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Opioid-free AnesthesiaExperimental Treatment1 Intervention

Patients will receive no intraoperative narcotics as part of their anesthesia regimen

Group II: Opioid AnesthesiaActive Control1 Intervention

Patients will receive intraoperative narcotics as part of their anesthesia regimen

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Who is running the clinical trial?

University of South FloridaLead Sponsor

407 Previous Clinical Trials

186,709 Total Patients Enrolled

Enrico Camporesi, MDPrincipal InvestigatorUniversity of South Florida

1 Previous Clinical Trials

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research include older individuals as participants?

"The target population for recruitment in this clinical trial are patients who fall between 18 and 80 years old."

Answered by AI

Who does this experiment require as participants?

"This study is enrolling around 100 individuals who have undergone colectomy and are between the ages of 18-80."

Answered by AI

How many people can join this clinical trial at its maximum capacity?

"Yes, according to the information available on clinicaltrials.gov, this study is still recruiting patients. The listing was first posted on December 1st, 2018 and was last updated on May 23rd, 2022. They are looking for 100 individuals total at a single site."

Answered by AI

Are people with the specific condition required for this trial currently being accepted?

"That is correct. The listing on clinicaltrials.gov says that this study, which was first advertised on December 1st 2018, is seeking patients at present. They are looking for 100 people to participate at a single site."

Answered by AI

What are the measurable goals of this experiment?

"The primary outcome variable that will be monitored weekly for 12 months is post-surgical opioid prescription use in pills per week. Secondary outcome measures include length of stay in hours, patient satisfaction based on survey results, and pain scores every 15 minutes on a visual analogue scale from 0 to 10 cm."

Answered by AI

Recent research and studies

AnesthesiologyJournal

Does Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?

Mauermann, Eckhard, Joerg Filitz, Patrick Dolder, Katharina M. Rentsch, Oliver Bandschapp, and Wilhelm Ruppen. 2016. “Does Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aln.0000000000000976.

JAMA SurgeryJournal

New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults

Brummett, Chad M., Jennifer F. Waljee, Jenna Goesling, Stephanie Moser, Paul Lin, Michael J. Englesbe, Amy S. B. Bohnert, Sachin Kheterpal, and Brahmajee K. Nallamothu. 2017. “New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults”. JAMA Surgery. American Medical Association (AMA). doi:10.1001/jamasurg.2017.0504.

JamaJournal

CDC Guideline for Prescribing Opioids for Chronic Pain—united States, 2016

Dowell, Deborah, Tamara M. Haegerich, and Roger Chou. 2016. “CDC Guideline for Prescribing Opioids for Chronic Pain—united States, 2016”. Jama. American Medical Association (AMA). doi:10.1001/jama.2016.1464.

Anesthesia & AnalgesiaJournal