ANI-Guided Opioid Administration for Acute Pain During Surgery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Antimuscarinics, Alpha 2 agonists

Disqualifiers: Pregnancy, Pacemaker, Chronic opioids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Intraoperative period

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for providing pain relief during surgery. It compares two approaches: ANI-guided opioid administration, which uses a special tool to guide painkiller doses, and standard opioid administration, which follows standard practice. The goal is to determine if this tool can enhance pain management during and after surgery. Individuals who have undergone planned abdominal or spinal surgery with anesthesia, do not have heart or lung issues, and can consent in English or Spanish may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative pain management techniques that could improve surgical outcomes.

Will I have to stop taking my current medications?

The trial requires that you do not take certain medications like antimuscarinic agents, alpha 2 agonists, antiarrhythmics, beta blockers, or chronic opioids. If you are on these medications, you may need to stop them to participate.

What prior data suggests that ANI-guided opioid administration is safe for surgical patients?

Research shows that using the Analgesia Nociception Index (ANI) to guide pain medication during surgery can effectively manage pain. Studies have found that patients with ANI-guided pain management often require less opioid medication. This suggests that the method might be safer by potentially lowering the risk of side effects from high opioid doses.

While the materials provided do not specify negative effects related to ANI-guided opioid use, using less opioid medication generally results in fewer side effects. Common opioid side effects include nausea and drowsiness, which can be concerning.

Overall, guiding opioid use with ANI during surgery appears well-tolerated and focuses on reducing opioid requirements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ANI-guided opioid administration because it offers a personalized approach to pain management during surgery. Unlike traditional methods that follow standard dosing protocols, this technique uses the analgesia nociceptive index (ANI) to tailor opioid dosages to the patient's specific needs in real-time. This could potentially reduce the risk of over-sedation or under-treatment of pain, leading to better outcomes and enhancing patient safety.

What evidence suggests that this trial's treatments could be effective for acute pain during surgery?

This trial will compare ANI-guided opioid administration with standard opioid administration during surgery. Research has shown that using the Analgesia Nociception Index (ANI) during surgery can help doctors administer the correct amount of pain medication. ANI distinguishes between when a patient is in pain and when they are not, even under anesthesia. This approach has reduced the amount of pain medication needed during surgery, potentially lowering the risk of side effects. However, some studies found that ANI did not significantly reduce moderate to severe pain after surgery compared to standard methods. Overall, using ANI to guide pain medication appears promising for better management, but it may not always affect pain levels post-surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Tiffany Moon, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75, with a BMI of 19-35 kg/m2, undergoing abdominal or spinal surgery under general anesthesia with sevoflurane-fentanyl. Participants must speak English or Spanish and have no advanced lung or heart disease. Excluded are those on certain heart medications, chronic opioids users, pregnant/nursing women, and those with irregular heart rhythms.

Inclusion Criteria

You are in good to excellent overall health.

Your body mass index (BMI) is between 19 and 35.

Willing and able to consent in English or Spanish

Exclusion Criteria

Patient refusal

Your heart rhythm is not regular.

You have a pacemaker.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ANI-guided or standard care opioid administration during surgery

Intraoperative period

1 visit (in-person, surgical procedure)

Postoperative Recovery

Participants are monitored for pain, nausea, and opioid use in the PACU

Postoperative recovery period, an average of 1 hour

1 visit (in-person, PACU)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ANI-guided opioid administration
• Standard opioid administration

Trial Overview The study compares ANI-guided opioid administration to standard care in managing pain during and after surgery. It's randomized: patients are put into the ANI group or standard care by chance. The team assessing post-surgery recovery won't know which group patients were in to avoid bias.

How Is the Trial Designed?

Group I: ANI-guided opioid administration Experimental Treatment 1 Intervention

Intraoperative opioid will be administered based on the analgesia nociceptive index (ANI)

Group II: Standard opioid administration Active Control 1 Intervention

Intraoperative opioid will be administered by guiding standard practice

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Citations

1. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-021-01272-2

Comparative study of analgesia nociception index (ANI) vs ... The aim of the current study was to compare the efficacy of ANI with standard pharmacokinetic pattern to guide intraoperative fentanyl administration.

2. sciencedirect.com sciencedirect.com/science/article/pii/S000709121731677X

Postoperative pain after laparoscopic cholecystectomy is ... The usage of ANI guidance did not result in a decrease in the rate of moderate/severe pain (50.8% vs 45.0%: difference of −5.8%, 95% confidence interval, −23.7% ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10608238/

Pain Assessment Using the Analgesia Nociception Index (ANI ... The analgesia nociception index (ANI) has emerged as a potential measurement for objective pain assessment during general anesthesia.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03684590?tab=table

ANI Versus Standard Care in Surgical Patients Receiving ... This study aims to be a randomized, controlled study of ANI-guided opioid administration versus standard clinical practice in surgical patients undergoing ...

5. epain.org epain.org/journal/view.html?uid=1899&vmd=Full

Pain assessment using the Analgesia Nociception Index in ... ANI effectively differentiated between the pain and non-pain states in sedated patients with moderate diagnostic accuracy and helped reduce opioid consumption.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5695271/

Postoperative pain management in the postanesthesia care unit Acute postoperative pain remains a major problem, resulting in multiple undesirable outcomes if inadequately controlled.

7. mdpi.com mdpi.com/2227-9032/9/3/333

Perioperative Pain Management and Opioid Stewardship This review seeks to summarize and integrate key recommendations into a “roadmap” for institutional adoption of perioperative analgesic and opioid optimization ...