The Effect of Nociception Level (NOL) Monitoring on Intraoperative Opioid Consumption in Hip Surgeries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Those whose opioids were adjusted according to hemodynamic parameters, Those whose opioids were adjusted according to NOL monitoring.
- Who it may be relevant to
- Registry conditions: Post Operative Pain, Opioid Use. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Those whose opioids were adjusted according to hemodynamic parameters
Patient who will be adjusted according to hemodynamic parameter - Procedure Those whose opioids were adjusted according to NOL monitoring
Patient who will be adjusted according to NOL monitoring
Primary outcome measures
- Remifentanil consumption [Time frame: Intraoperative]
- NRS Scores [Time frame: Postoperative 1st, 6th, 12th and 24th hours]
- Morphine consumption [Time frame: Postoperative 1st, 6th, 12th and 24th hours]
Secondary outcome measures (2)
- Rescue analgesic [Time frame: Postoperative 1st, 6th, 12th and 24th hours]
- Nausea and vomiting [Time frame: Postoperative 1st, 6th, 12th and 24th hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06558149 · KAD-DD- 01