What side effects are associated with this type of intervention?

Common treatments for postoperative pain include NSAIDs, acetaminophen, and non-pharmacological interventions. NSAIDs can cause gastrointestinal issues, renal impairment, and cardiovascular problems, especially in patients with pre-existing conditions. Acetaminophen is generally well-tolerated but can lead to liver damage if taken in excessive doses. Non-pharmacological interventions, such as physical therapy and cognitive-behavioral therapy, have few reported adverse effects but require more rigorous trials to fully understand their safety and efficacy.

What prior FDA approvals exist?

The FDA has approved several non-opioid medications for the treatment of postoperative pain, including NSAIDs like ibuprofen and acetaminophen. These medications are often recommended due to their efficacy in reducing pain and minimizing opioid-related side effects. Studies have shown that NSAIDs can provide better global improvement in pain management compared to placebo, although their effectiveness for acute pain relief is still debated. Additionally, intravenous acetaminophen has been used as an adjunct analgesic in postoperative settings, reducing opioid consumption without increasing opioid-related adverse effects. Other non-opioid alternatives being explored include topical agents like diclofenac gel and patches, which have shown efficacy in managing localized pain.

What other types of research exist?

Promising alternatives to non-opioid pain management for postoperative patients in 2024 include: 1) Mind-body therapies such as mindfulness, meditation, and guided imagery, which have shown effectiveness in reducing pain perception. 2) Psychological techniques like cognitive-behavioral therapy (CBT) and acceptance and commitment therapy (ACT) that help patients manage pain through mental strategies. 3) Physical rehabilitation methods including physical therapy and exercise programs tailored to enhance recovery and reduce pain. 4) Complementary medicine approaches such as acupuncture and transcutaneous electrical nerve stimulation (TENS). 5) Novel pharmacological agents like acetyl-L-carnitine and topical treatments (e.g., amitriptyline and ketamine creams) that target specific pain pathways without the risks associated with opioids.

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Non-Opioid Pain Management After Surgery (NOPIOiDS Trial)

N/A

Waitlist Available

Led By Badar Mian, MD

Research Sponsored by Albany Medical College

Eligibility Criteria Checklist

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

Must have

All patients undergoing major urologic cancer surgery, either open or laparoscopic, will be included in the study.

This will include all open or laparoscopic or robotic surgery including radical prostatectomy, radical cystectomy, radical nephrectomy, partial nephrectomy, nephron-ureterectomy, and similar procedures.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to stop or greatly reduce giving opioid painkillers to patients after major urology surgeries to prevent long-term use and addiction.

Who is the study for?

This trial is for patients undergoing major urologic cancer surgeries like prostatectomy, cystectomy, or nephrectomy. It's open to those who can have surgery either through traditional (open) methods or minimally invasive techniques (laparoscopic/robotic). People with allergies or intolerance to NSAIDs may not participate.

What is being tested?

The study aims to eliminate opioid prescriptions at discharge after major urologic surgeries. The focus is on whether patients can recover without opioids and avoid the risk of developing a habit or persistent use associated with postoperative pain management.

What are the potential side effects?

Since this trial involves not prescribing opioids, there are no direct side effects from medications being tested. However, participants might experience different levels of postoperative pain managed by alternatives to opioids.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am having major surgery for urologic cancer, no matter the method.

Select...

I have undergone major surgery for urological cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

All opioids prescriptions within 30 days of surgery

Opioids

Secondary study objectives

Contact with healthcare facilities

Post-operative pain after discharge

Satisfaction score during home recovery

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: No opioids prescriptions at dischargeExperimental Treatment1 Intervention

Patients will receive non-opioid analgesia, mostly over the counter, medications such as acetaminophen or ibuprofen. Opioids may be prescribed if the patients experience break through pain and call the office.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

No opioids at discharge

2018

N/A

~350

0 / 2Eligibility 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

The most common non-opioid treatments for postoperative pain include NSAIDs, acetaminophen, and topical agents like diclofenac and capsaicin. NSAIDs inhibit cyclooxygenase enzymes, reducing the formation of pain-causing prostaglandins. Acetaminophen likely works through central COX inhibition and modulation of the endocannabinoid system. Topical agents provide localized relief; diclofenac reduces inflammation by inhibiting COX enzymes, and capsaicin depletes substance P, a neuropeptide involved in pain transmission. These mechanisms are important for postoperative pain patients as they offer effective pain relief while minimizing the risk of opioid dependency and side effects.

Challenges and opportunities in translational pain research - An opinion paper of the working group on translational pain research of the European pain federation (EFIC).Pathophysiologic Approach to Pain Therapy for Complex Pain Entities: A Narrative Review.