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

Not Applicable

Not yet recruiting

• Conditions: Opioid Use; Post Operative Pain
• Interventions: Procedure: Those whose opioids were adjusted according to hemodynamic parameters; Procedure: Those whose opioids were adjusted according to NOL monitoring

• Registration Number: NCT06558149
• Lead Sponsor: Kocaeli University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-14
• Study First Posted: 2024-08-16
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09
• Study Start: 2024-12-15
• Primary Completion: 2025-08-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Analgesic use according to hemodynamics patients to be treated	Those whose opioids were adjusted according to hemodynamic parameters	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
Patients who will use analgesics according to NOL monitoring	Those whose opioids were adjusted 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.

Primary Outcome Measures

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

Secondary Outcome Measures

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