NOL Guided Analgesia for Spinal Surgery

JB
Overseen ByJaime Baratta, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if NOL (nociception level index) monitoring can improve pain management during and after spine surgery. It focuses on patients undergoing procedures like laminectomy, spinal fusion, or disc replacement under general anesthesia. The trial will assess whether NOL-guided intraoperative analgesia affects the amount of pain medication needed and the overall surgical experience. Suitable participants are those advised by a doctor to undergo spine surgery and who consent to general anesthesia. As an unphased trial, this study allows patients to contribute to innovative pain management research that could enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude those who have used psychoactive drugs in the last 90 days or are currently using IV opioids. It's best to discuss your specific medications with the trial team.

What prior data suggests that NOL guided intraoperative analgesia is safe for spinal surgery?

Research has shown that using NOL (Nociception Level) monitoring to manage pain during surgery can be safe for patients. In studies where NOL guided anesthesia, patients often required smaller doses of fentanyl, a common pain medication. This method reduced the drug dose by about 25% compared to those without NOL guidance. Smaller doses are generally safer, leading to fewer side effects.

Moreover, patients experienced less pain after surgery with NOL. One study found that pain levels dropped by 33% in those with NOL-guided anesthesia compared to those without it. Lower pain levels typically result in fewer complications and a smoother recovery.

Overall, current research suggests that NOL-guided pain management during surgery is well-tolerated and may improve recovery by reducing the need for large amounts of pain medication.12345

Why are researchers excited about this trial?

NOL guided intraoperative analgesia is unique because it uses a novel approach to manage pain during spinal surgery. Unlike traditional methods that rely on fixed doses of painkillers, this technique leverages real-time monitoring of a patient's nociception level (which is how the body processes pain) to tailor the analgesia dosage precisely. Researchers are excited about this method because it promises to improve pain management by minimizing over- or under-dosing, which could lead to faster recovery and fewer side effects for patients undergoing spinal surgery.

What evidence suggests that NOL guided intraoperative analgesia is effective for spinal surgery?

Research has shown that using the nociception level index (NOL) to guide pain relief can significantly improve pain management during and after spine surgery. One study demonstrated that NOL guidance reduced the amount of fentanyl needed during surgery by 25%. Another study found that patients experienced less pain post-surgery, with average pain scores of 3.0 compared to 5.0 for those without NOL-guided treatment. This trial will include a retrospective cohort arm, using data from the hospital's EMR system to compare outcomes. These findings suggest that NOL monitoring helps customize pain relief more effectively, potentially leading to better patient outcomes.23678

Are You a Good Fit for This Trial?

This trial is for people undergoing spine surgery under general anesthesia. Participants are likely adults scheduled for this type of surgery, but specific inclusion and exclusion criteria are not detailed.

Inclusion Criteria

Opioid tolerant and patients with documented chronic pain may be included
Patient able to provide informed consent
ASA I-III
See 2 more

Exclusion Criteria

Non-sinus heart rate
Pregnancy or lactation
I have used psychoactive drugs regularly in the past 90 days.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative Monitoring

NOL nociception level index monitoring is used to guide intraoperative analgesia dosing during spine surgery under general anesthesia

1 day
1 visit (in-person)

Postoperative Ward Recovery

Participants are monitored for postoperative outcomes including opioid consumption, pain intensity, and patient satisfaction

3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • NOL guided intraoperative analgesia

Trial Overview

The study tests whether using the NOL (Nociception Level Index) monitor to guide pain medication during spine surgery improves patient outcomes compared to past cases where standard monitoring was used.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Retrospective cohortExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medasense Biometrics Ltd

Lead Sponsor

Trials
16
Recruited
900+

Thomas Jefferson Health

Collaborator

Citations

Intraoperative Nociception Monitoring Using the NoL Index

These findings suggest that NoL monitoring may help identify high-nociception phases and guide tailored analgesic strategies. Future randomized ...

Pain Efficacy of perioperative pharmacological and ...

Double-drug therapy was less effective, but showed moderate morphine reduction in a range of –15 to –17 mg and pain score reduction in a range of –1 to –1.6.

3.

associationofanaesthetists-publications.onlinelibrary.wiley.com

associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.16148

Effect of nociception level index‐guided intra‐operative ...

The primary outcomes were pain intensity and opioid consumption during the first 60–120 min after surgery. Secondary outcomes were the incidence ...

The Role of Multimodal Analgesia in Spine Surgery

This project proposes a scoping review to examine the role of multimodal analgesia. (MMA) in reducing opioid consumption and improving surgical ...

Impact of NOL - Nociception Level Index Intraoperative ...

The study will assess the impact of intraoperative use of NOL nociception monitoring in in-hospital spine surgery procedures performed under ...

Impact of NOL - Nociception Level Index Intraoperative ...

The objective of this study is to evaluate the clinical impact of the device on intraoperative and post operative patient outcomes and ...

Reduced postoperative pain using Nociception Level ...

Use of the NOL index to guide intraoperative fentanyl dosing resulted in reduced postoperative pain scores and a smaller increase in stress hormones.

Intraoperative Analgesia Guided by the Nociception Level ...

Conclusion: NOL guidance resulted in a statistically significant reduction of 25% in the doses of fentanyl administered in the NOL guided group ...