Anesthesia , Analgesia, Pain After Surgery, Spine Surgery
Conditions
Keywords
nociception, pain, NOL nociception level index, quality improvement
Brief summary
The objective of this study is to evaluate the clinical impact of the NOL nociception level index monitoring on intraoperative and post operative patient outcomes and institutional metrics when used to guide intraoperative analgesia dosing in patients undergoing spine surgery under general anesthesia when compared to a case controlled retrospective cohort.
Detailed description
The study will assess the impact of intraoperative use of NOL nociception monitoring in in-hospital spine surgery procedures performed under general anesthesia on post operative patient outcomes. The study is designed as a quality improvement project with the prospective outcomes to be compared to a retrospective matched cohort. The objective of this study is to evaluate the clinical impact of the device on intraoperative and post operative patient outcomes and institutional metrics when used to guide intraoperative analgesia dosing in patients undergoing spine surgery under general anesthesia when compared to a case controlled retrospective cohort. The clinical impact will also be translated into economic metrics. Secondary endpoints 1. Reduction in time to extubation 2. Reduction in time to PACU discharge readiness 3. Reduction in anesthesia related adverse events: 1. PONV 2. Respiratory depression defined as respiratory rate (RR) below 8 respirations per minute (RPM) for 1 minute. Saturation of less than 90% for 1 minute under continuous monitoring 3. Somnolence 4. Sedation (Pasero score) 5. Discharge readiness (modified Aldrete score) 6. PACU pain intensity (NRS pain intensity ratings measured according to SOC) 6.3 Exploratory endpoints INTRAOPERATIVE 1. Reduction in hemodynamic instability (hypertension, hypotensive events) 2. Use of vasoactive medication (ephedrine, phenylephrine, norepinephrine, atropine) 3. Association between time spent with NOL values above 25 and PACU pain intensity ratings WARD - up to 48 hours post surgery 1. Patient reported satisfaction levels using questionnaire QR15 2. Pain intensity (Time points: NRS according to the SOC)) 3. 48 hours post-operative opioid consumption 4. Requirement for Acute Pain Service consultation 5. Reduction in rescue opioid requirements 6. Ketamine prescription on the ward 7. Opioid prescription on the ward 8. PONV medication consumption 9. Clinician survey on the device
Interventions
DEVICENOL guided intraoperative analgesia
The PMD-200 monitor with the NOL index will be used to guide analgesia dosing during anesthesia maintenance as an adjunct monitor used alongside other anesthesia monitors. If the NOL value is above 25 for sixty seconds or more, clinicians will evaluate whether more analgesia is needed. If the NOL value is below 25 the patient is considered to have adequately managed nociception.
Sponsors
Medasense Biometrics Ltd
Thomas Jefferson Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years old. * ASA I-III * Elective spine surgery (laminectomy, spinal fusion, and disc replacement) under general anesthesia. * Opioid tolerant and patients with documented chronic pain may be included * Patient able to provide informed consent
Exclusion criteria
* • Use of any type of anesthesia other than general anesthesia (neuraxial, epidural analgesia or local regional anesthesia) * Use of intraoperative methadone * Non-sinus heart rate * Pregnancy/lactation * Chronic use of psychoactive drugs within 90 days prior to surgery * Patients currently using IV opioids (IV drug abuse) * Allergy or intolerance to any of the study anesthesia related drugs * History of severe cardiac arrhythmias within the last 12 months * Surgeries less than 1.5 hours (from incision to extubation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total opioid requirement during surgery and PACU stay | One day | Total opioid requirement during surgery and PACU stay reported in morphine equivalents (mgs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in time to extubation | one day | Reduction in time to extubation measured in minutes |
| Reduction in time to PACU discharge readiness | one day | Reduction in time to PACU discharge readiness measured in minutes |
| Modified Aldrete Score | one day | Modified Aldrete Score (scale of 0-10) |
| Reduction in PACU pain intensity rating | one day | Reduction in PACU pain intensity rating (NRS scale of 0-10 ) |
| Anesthesia Related Adverse Events - PONV | 1 day | PONV in PACU assessed used accepted PONV symptom scale (0-4) |
| Anesthesia Related Adverse Events in PACU - Respiratory Depression | one day | Respiratory depression defined as respiratory rate (RR) below 8 respirations per minute (RPM) for 1 minute. Saturation of less than 90% for 1 minute under continuous monitoring |
| Anesthesia Related Adverse Events in PACU - Sedation & Somnolence | one day | Sedation \& Somnolence using Pasero Scale (S 1-4) |
Countries
United States
Contacts
CONTACTJaime Baratta, MD
Outcome results
None listed