Post Operative PainNCT06558149
The Effect of Nociception Level (NOL) Monitoring on Intraoperative Opioid Consumption in Hip Surgeries
A study testing Those whose opioids were adjusted according to hemodynamic parameters and Those whose opioids were adjusted according to NOL monitoring in people with Post Operative Pain and Opioid Use, run by Kocaeli University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Operative Pain, Opioid Use
- What is being tested?
- Those whose opioids were adjusted according to hemodynamic parameters and Those whose opioids were adjusted according to NOL monitoring
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA (American Society of Anesthesiologists) physical status classification I-IV patients who are planned to undergo hip surgery
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Post Operative Pain, Opioid Use
- Being tested
- Those whose opioids were adjusted according to hemodynamic parameters, Those whose opioids were adjusted according to NOL monitoring
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Those whose opioids were adjusted according to hemodynamic parametersProcedure or surgery
Patient who will be adjusted according to hemodynamic parameter
Those whose opioids were adjusted according to NOL monitoringProcedure or surgery
Patient who will be adjusted according to NOL monitoring
| Study group | Role | What they receive |
|---|---|---|
| Analgesic use according to hemodynamics patients to be treated | Active comparator | 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 Receives: Procedure: Those whose opioids were adjusted according to hemodynamic parameters |
| Patients who will use analgesics according to NOL monitoring | Active comparator | 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. Receives: Procedure: Those whose opioids were adjusted according to NOL monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remifentanil consumption
Total amount of remifentanil used during the surgery (mg)
Measured: Intraoperative
NRS Scores
Numeric Rating Scale scores, between 0-10 (0= no pain, 10=worst pain imaginable)
Measured: Postoperative 1st, 6th, 12th and 24th hours
Morphine consumption
Amount of morphine in the postoperative period (mg)
Measured: Postoperative 1st, 6th, 12th and 24th hours
Secondary outcomes (2)
Rescue analgesic
The use of rescue analgesic
Measured: Postoperative 1st, 6th, 12th and 24th hours
Nausea and vomiting
If the patient had nausea or vomiting, it will be recorded.
Measured: Postoperative 1st, 6th, 12th and 24th hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start15 Dec 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadi Ufuk Yörükoğlu, Kocaeli University
- Investigators
- Hadi Ufuk Yörükoğlu, Principal investigator, Kocaeli University, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558149
- Sponsor's protocol ID
- KAD-DD- 01
- Status last verified
- Oct 2024
- First submitted
- 14 Aug 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nociception Level (NOL) Monitoring on Intraoperative Opioid Consumption in Hip Surgeries
- ClinicalTrials.gov ID
- NCT06558149
- Acronym / sponsor ID
- KAD-DD- 01
- Conditions
- Post Operative Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Analgesic use according to hemodynamics patients to be treated | Active comparator | Procedure: Those whose opioids were adjusted according to hemodynamic parametersProcedure/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 | Active comparator | Procedure: Those whose opioids were adjusted according to NOL monitoringProcedure/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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA (American Society of Anesthesiologists) physical status classification I-IV patients who are planned to undergo hip surgery
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Those whose opioids were adjusted according to hemodynamic parametersPatient who will be adjusted according to hemodynamic parameter | Procedure or surgery | Analgesic use according to hemodynamics patients to be treated |
| Those whose opioids were adjusted according to NOL monitoringPatient who will be adjusted according to NOL monitoring | Procedure or surgery | Patients who will use analgesics according to NOL monitoring |
Primary outcome
Remifentanil consumption
Time frame: Intraoperative
Total amount of remifentanil used during the surgery (mg)
NRS Scores
Time frame: Postoperative 1st, 6th, 12th and 24th hours
Numeric Rating Scale scores, between 0-10 (0= no pain, 10=worst pain imaginable)
Morphine consumption
Time frame: Postoperative 1st, 6th, 12th and 24th hours
Amount of morphine in the postoperative period (mg)
2 secondary outcomes
Rescue analgesic
Time frame: Postoperative 1st, 6th, 12th and 24th hours
Nausea and vomiting
Time frame: Postoperative 1st, 6th, 12th and 24th hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadi Ufuk Yörükoğlu principal investigator
Kocaeli University, Department of Anesthesiology and Reanimation
Questions about this trial
What is this clinical trial studying?
A study testing Those whose opioids were adjusted according to hemodynamic parameters and Those whose opioids were adjusted according to NOL monitoring in people with Post Operative Pain and Opioid Use, run by Kocaeli University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Bulut (+902623038248, bulutmehmet114@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remifentanil consumption (time frame: Intraoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.