Prediction of Postoperative Pain by Nociception Monitoring

NCT05063227 | Completed

• 1 other identifier: 2021-06
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

General anesthesia is a combination of hypnotic drugs and opioid analgesics. Modern general anesthesia aims to treat nociception induced by surgical stimulation while avoiding an overdose of opioid analgesics and reducing side-effects of opioid administration. Quality and safety of general anesthesia are of major clinical importance and can be improved by adjusting the opioid analgesics to the optimal individual dose needed. In the current clinical practice, the opioid dosage is usually chosen by clinical judgment, though recently different monitoring devices estimating the effect of nociception during unconsciousness have become commercially available. Nevertheless, the impact of nociception-monitor-guided opioid administration on the administered amount of opioid, postoperative short-term recovery, and long-term outcome is inconclusive. This study aims to investigate the predictive power of different nociception monitoring systems for the prediction of moderate to severe immediate postoperative pain from nociception indices measured before awakening from general anesthesia.

Conditions

Pain, Postoperative; Analgesia; Anesthesia Recovery Period; Opioid Use

Keywords

Analgesia Monitoring; General anesthesia

Outcome Measures

Primary Outcomes (1)

• Primary endpoint will be the diagnostic accuracy (ROC analysis) of the nociception indices after the end of surgery to predict moderate to severe immediate postoperative pain

  Numerical Rating Scale (NRS) Scale 4-10 NRS has a minimal value of 0 and a maximal value of 10, higher scores mean a worse outcome (higher pain level).

  Once immediately after arrival in the post-anesthesia care unit (PACU)

Secondary Outcomes (5)

• The correlation between the nociception indices after the end of surgery and immediate postoperative pain measured with the NRS on a scale of 0 - 10

  Once immediately after arrival in the post-anesthesia care unit (PACU)

• The correlation between the nociception indices after the end of surgery and postoperative pain measured with the NRS on a scale of 0 - 10 after 60 minutes in PACU

  First 60 minutes after arrival in the PACU

• Correlation between the nociception indices and the highest postoperative NRS

  Once in the first 2 hours during the PACU stay

• The correlation between the nociception indices after the end of surgery and the amount of opioids in the first 30 minutes after surgery

  Time period of first 30 minutes during the PACU stay

• The correlation between the nociception indices after the end of surgery and the amount of opioids in up to 2 hours after surgery

  Time period of first 2 hours during the PACU stay

Study Arms (1)

Study group

As this is a single-group, observational study all patients will be monitored with all three nociception monitoring systems (the Surgical Pleth Index (SPI), the Pupillary Pain Index (PPI) and the Nociception Level (NOL)) and data on heart rate changes as a variable used in current clinical practice to choose the opioid dosage during general anesthesia will be obtained additionally.

Diagnostic Test: Observational: analgesia monitoring indices and changes in heart rate

Interventions

Observational: analgesia monitoring indices and changes in heart rate DIAGNOSTIC_TEST

After the end of surgery (defined as the time of skin closure or wound dressing), but before awakening (BIS will still be \< 60), SPI, PPI and NOL are recorded in a quiet setting without any other stimulation. Within the five minutes data acquisition period nociception indices are recorded every minute (T0, T1, T2, T3, T4, T5). The highest SPI, PPI and NOL are used for further analysis.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study includes all patients with elective trauma surgery and orthopedic surgery scheduled on a weekday Monday to Friday in the operation theater where the study is conducted,which do not present with an exclusion criterion. There is no further eligibility criteria and thusly, this is a non-sepcified study on all patients that meet the requirements for the three analgesia monitoring devices.

You may qualify if:

• Patients with elective trauma surgery and orthopedic surgery scheduled on a weekday Monday to Friday in the operation theater where the study is conducted

You may not qualify if:

• Beta blocker, digitalis or cardiac pacemaker therapy
• Higher degrees of cardiac arrhythmias, e.g. atrial fibrillation and atrio-ventricular block \>1st degree
• Severe peripheral or cardiac neuropathy
• Eye disease with affection of pupil reactivity
• Intraoperative treatment with ketamine, beta-receptor blockers, beta-receptor agonists or clonidine and treatment with vasoactive medication within 10 min before and during data acquisition period
• Inability to adequately specify postoperative pain level
• Postoperative care in the intensive care unit (ICU) or postanesthesia care unit with planned overnight stay (PACU24, intermediate care unit IMC)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Rainer Nitzschke

Hamburg, 20246, Germany

Location

Related Publications (1)

• Koschmieder KC, Funcke S, Shadloo M, Pinnschmidt HO, Greiwe G, Fischer M, Nitzschke R. Validation of three nociception indices to predict immediate postoperative pain before emergence from general anaesthesia: a prospective double-blind, observational study. Br J Anaesth. 2023 Apr;130(4):477-484. doi: 10.1016/j.bja.2022.11.024. Epub 2023 Jan 4.

  PMID: 36609057 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Rainer Nitzschke, MD

  Center for Anesthesiology and Intensive Care Medicine, University Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2021
• First Posted: October 1, 2021
• Study Start: October 6, 2021
• Primary Completion: December 2, 2021
• Study Completion: January 4, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-07

Locations

DE (1)