The Effect of Nociception Level (NOL) Monitoring on Intraoperative Opioid Consumption in Hip Surgeries

Hip surgeries are one of the most painful surgical operations, and inadequate pain management increases postoperative morbidity and mortality.The incidence of chronic pain after hip surgery is quite high, at 11-40%.For this reason, hip surgeries are complex and specialized surgeries in terms of pain management.According to the surgical procedures pioneered by the European Society of Regional Anesthesia, Pericapsular nerve block (PENG) block is among the recommendations with a high level of evidence for hip surgery in the multimodal analgesia steps guide.In the literature, there are studies comparing the postoperative analgesic effectiveness of PENG block in hip surgeries, but the results are contradictory.In addition, intraoperative pain monitoring was not used in these studies, instead intraoperative analgesia management was provided according to hemodynamic parameters, which may not be objective.Opioid infusion is used in analgesia management during the intraoperative period.While not providing effective analgesia due to insufficient opioid use will have effects, excessive opioid use also has many side effects.Therefore, it would not be correct to administer the same dose of opioid infusion to every patient. As seen in the data in the literature and in daily practice, hemodynamic parameters (such as heart rate, blood pressure) are used for pain monitoring of the patient under general anesthesia, and these parameters may change depending on many other factors.Although some devices that aim to provide pain monitoring by evaluating the effects of pain on the sympathetic system are available on the market, their usage areas have remained limited since their reliability has not been fully demonstrated. Nociception level index (NoL) monitoring provides effective monitoring as it evaluates each patient separately using different parameters (heart rate, heart rate variability, photo-plethysmographic waveform amplitude, skin conductance level, number of skin conductance fluctuations and their time derivatives).While planning this study, İnvestigators aimed to use NoL monitoring in hip surgery, where postoperative pain management is quite challenging and important, as it provides objective and personalized pain management in patients under general anesthesia.When other studies in the literature are examined, the effects of regional techniques have been compared only in the postoperative period.Its effects in the intraoperative period have not been evaluated on a patient basis, and the opioid infusion rate has been adjusted with hemodynamic findings, which are affected by many parameters such as bleeding and drug use.In this study, İnvestigators aim to compare the effects of intraoperative pain monitoring and personalized analgesia treatment and the regional technique both in the intraoperative period and in the postoperative period.

Study Overview

• Status: Not yet recruiting
• Conditions: Opioid Use; Post Operative Pain
• Intervention / Treatment: Procedure: Those whose opioids were adjusted according to hemodynamic parameters; Procedure: Those whose opioids were adjusted according to NOL monitoring

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mehmet Bulut; Phone Number: +902623038248; Email: bulutmehmet114@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ASA (American Society of Anesthesiologists) physical status classification I-IV patients who are planned to undergo hip surgery

Exclusion Criteria:

• Allergies to study medications
• serious renal, pulmonary, liver and endocrine diseases
• have a history of chronic pain
• Those with a history of bleeding diathesis
• Those with increased intracranial pressure
• Those with severe mitral and/or aortic stenosis
• patients with psychiatric diseases and communication difficulties

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Analgesic use according to hemodynamics patients to be treated; Procedure/Surgery: Pericapsular nerve group block(PENG) Before the general anesthesia induction, Peng block will be performed between the psoas tendon and the ilium with 0.25% bupivacaine (20 mL) using ultrasound and will be adjusting opioid infusion rate according to hemodinamic parameters	Procedure: Those whose opioids were adjusted according to hemodynamic parameters; Patient who will be adjusted according to hemodynamic parameter
Active Comparator: Patients who will use analgesics according to NOL monitoring; Procedure/Surgery: Pericapsular nerve group block(PENG) Before the general anesthesia induction, Peng block will be performed between the psoas tendon and the ilium with 0.25% bupivacaine (20 mL) using ultrasound and will be adjusting opioid infusion rate according to NOL monitoring.	Procedure: Those whose opioids were adjusted according to NOL monitoring; Patient who will be adjusted according to NOL monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remifentanil consumption	Total amount of remifentanil used during the surgery (mg)	Intraoperative
NRS Scores	Numeric Rating Scale scores, between 0-10 (0= no pain, 10=worst pain imaginable)	Postoperative 1st, 6th, 12th and 24th hours
Morphine consumption	Amount of morphine in the postoperative period (mg)	Postoperative 1st, 6th, 12th and 24th hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rescue analgesic	The use of rescue analgesic	Postoperative 1st, 6th, 12th and 24th hours
Nausea and vomiting	If the patient had nausea or vomiting, it will be recorded.	Postoperative 1st, 6th, 12th and 24th hours

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Hadi Ufuk Yörükoğlu, Kocaeli University, Department of Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start (Estimated): December 15, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 8, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: KAD-DD- 01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No