The Effects of Objective Estimation of Pain Response

NCT04114851 | Completed

• 1 other identifier: 2019-01023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

There are different types of pain generators that give different pain symptoms. In anesthesia and surgery, the pain generator in connection with, for example, surgical procedures is referred to as nociceptive pain. However, there is not enough evidence to support that these physiological changes are direct signs of nociceptive stimulation. The same changes can be seen with an autonomous stress trigger of origin other than just nociceptive stimulation. This means that healthcare professionals who provide anesthesia to patients during, for example, surgery may provide unnecessary pain relief drugs or do not provide pain relief when needed. This is also true in awake patients when pain is complex that, for example, concerns may increase the experience of pain and that healthcare professionals may even then misinterpret and provide more pain-relieving drugs despite the actual need for another drug or complementary treatment. Examples of these include heart rate variation, specific patterns in blood pressure and heart rate response, heart rate amplitude, heart rate range, skin sweating and pupil response. The reason why these changes have not been used to interpret nociceptive stimulation is directly linked to an absence of technology that makes it possible to collect data and interpret these changes. list a number of methods / techniques that are under development, one of which is the Nociception Level Index (NoL). NoL is an indexed value between 0 and 100 and is based on a non-linear combination of nociception-related physiological variables (including heart rate variation, plethysmograph pulse wave amplitude (PPGA) and changes in skin resistance). Possibly NoL is the first evidence-based clinical technology that can discriminate pain response when physiological response is not measured. The research field in the area of non-invasive objective monitoring of pain response in relation to patients' experience of pain is currently almost non-existent in anesthesia / anesthesia care This in turn can also lead to the development of patient safety both during anesthesia and after surgery at nursing department for example, patient-controlled and epidural pain relief in postoperative pain care. investigators intend to study the variation of the NoL index linked to the need for opioids during anesthesia and also after completed anesthesia when the patient wakes up and is in the ward.

Conditions

Anesthesia; Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Amount of opioid used

  Amount of opioid used

  24 hours

Study Arms (2)

Active

EXPERIMENTAL

Patients who get active monitor NoL

Device: NoL

control

NO INTERVENTION

control no NoL

Interventions

NoL DEVICE

NoL active

Active

Eligibility Criteria

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

You may qualify if:

• All patients over 18 yrs old

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Sahlgrenska University hospital

Gothenburg, 41300, Sweden

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: control group will be masked so that the monitor index will not be seen by the caregiver/investigator.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: RCT

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 3, 2019
• Study Start: November 30, 2019
• Primary Completion: December 10, 2024
• Study Completion: February 10, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

SE (1)