What side effects are associated with this type of intervention?

Opioid-free total intravenous anesthesia (TIVA) for postoperative recovery commonly involves agents like ketamine, lidocaine, and acetaminophen. Ketamine can cause psychomimetic effects such as hallucinations and confusion, as well as cardiovascular effects like increased blood pressure and heart rate. Intravenous lidocaine may lead to systemic toxicity, including neurological symptoms (e.g., dizziness, seizures) and cardiovascular issues (e.g., arrhythmias). Acetaminophen, while generally safe, can cause liver toxicity at high doses. These side effects are crucial to consider when aiming to improve postoperative recovery without opioids.

What prior FDA approvals exist?

The FDA has approved several non-opioid medications and techniques aimed at improving postoperative quality of recovery while minimizing opioid use. Notable examples include intravenous acetaminophen, which has been shown to reduce opioid consumption and improve pain management in various surgical settings. Additionally, dexmedetomidine, an alpha-2 adrenoceptor agonist, has been approved for its sedative and analgesic properties, contributing to enhanced recovery protocols. These treatments align with the goals of Opioid-Free Total Intravenous Anesthesia (OFTIVA) by providing effective pain relief and reducing the risk of opioid-related complications.

What other types of research exist?

Promising alternatives to Opioid-Free Total Intravenous Anesthesia for postoperative quality of recovery include: 1) Neuraxial anesthesia (e.g., spinal or epidural anesthesia), which has been shown to improve long-term survival and reduce postoperative complications in various surgeries. 2) Peripheral nerve blocks, such as femoral or adductor canal blocks, which provide effective pain relief with less quadriceps weakness, facilitating early mobilization. 3) Periarticular infiltration with long-acting local anesthetics and adjuvants, which can offer targeted pain control. 4) Multimodal analgesia protocols that combine non-opioid medications like NSAIDs, acetaminophen, and gabapentinoids to manage pain effectively while minimizing opioid use.

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Other

Opioid-Free Anesthesia for Bariatric Surgery

Phase 4

Waitlist Available

Led By Judith Aronsohn, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

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

Must have

Undergoing laparoscopic bariatric surgery for weight loss.

Be older than 18 years old

Must not have

Abnormal renal function

Any contraindication to any opioid or non-opioid pain analgesics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to postoperative day one

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a type of anesthesia that doesn't use opioids and is given through an IV. It is aimed at morbidly obese patients having weight-loss surgery, who often have problems with opioid side effects like breathing issues and nausea. The goal is to see if this method improves recovery after surgery by avoiding these complications.

Who is the study for?

This trial is for non-pregnant adults with a body mass index high enough to qualify for laparoscopic bariatric surgery, who are in relatively good health (ASA I-III). It's not suitable for those with severe systemic disease (ASA IV-V), active liver or kidney issues, substance misuse history, daily opioid use, or allergies to eggs/soy.

What is being tested?

The study compares two types of anesthesia during weight loss surgery: one using opioids and the other being opioid-free. The goal is to see which method leads to better recovery after surgery without the complications often caused by opioids.

What are the potential side effects?

While specific side effects aren't listed here, generally speaking, avoiding opioids may reduce risks like breathing problems and nausea after surgery. However, there could be discomfort or pain that typically would be managed by opioids.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for weight loss surgery using a minimally invasive method.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is not normal.

Select...

I cannot take certain painkillers due to allergies or side effects.

Select...

I have an active liver condition.

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I have been using opioids daily for pain management for a year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to postoperative day one

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to postoperative day one

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to postoperative day one for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of Recovery

Secondary study objectives

Opioid Consumption

Pain Intensities

Time to Aldrete Score of 9

Other study objectives

Postoperative Nausea and Vomiting

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Opioid Free Anesthesia GroupExperimental Treatment1 Intervention

Group II: Opioid Anesthesia GroupActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Opioid Free Total Intravenous Anesthesia

2021

Completed Phase 4

~60

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intravenous acetaminophen works by inhibiting the synthesis of prostaglandins in the central nervous system, which helps reduce pain and fever. NSAIDs, such as ibuprofen, inhibit cyclooxygenase (COX) enzymes, reducing the production of prostaglandins involved in inflammation and pain. Intravenous lidocaine stabilizes neuronal membranes by inhibiting sodium channels, which reduces pain signaling. These treatments are important for postoperative quality of recovery as they provide effective pain relief while minimizing the risk of opioid-related complications such as respiratory depression, nausea, and addiction. By using opioid-free analgesia, patients can experience a smoother recovery with fewer side effects, leading to improved overall outcomes.

Optimal management of perioperative analgesia regarding immediate and short-term outcomes after liver transplantation - A systematic review, meta-analysis and expert panel recommendations.Evaluation of an Opioid-Free Anesthesia Protocol for Elective Abdominal Surgery in a Community Hospital.Preventing opioid prescription after major surgery: a scoping review of opioid-free analgesia.