The Relationship Of The Surgical Pleth Index Values With Postoperative Pain Score And Analgesia C… (NCT05147714) | Clinical Trial Compass
CompletedNot Applicable
The Relationship Of The Surgical Pleth Index Values With Postoperative Pain Score And Analgesia Consumption
Turkey (Türkiye)52 participantsStarted 2019-01-01
Plain-language summary
Postoperative pain management has an important role in anesthesia practice. In order to ensure postoperative patient comfort, postoperative rehabilitation should start early and be managed effectively1. It is known that if adequate analgesia is not provided before the patient wakes up, the severity of pain and the total opioid consumption increases. This increased opioid use causes complications such as nausea, vomiting, constipation, increased sleepiness and respiratory depression2. For this reason, the provision of adequate analgesia before the patient is awakened from general anesthesia has an important place in the process. Measurement of pain has different characteristics in patients under sedation or general anesthesia compared to conscious patients. However, since it is not possible for the patient to define pain under general anesthesia, different measurement and evaluation methods are needed. In order to monitor the intraoperative balance between nociception and antinociception, several non-invasive methods with different physiological approaches have been researched and made available for use in the last decade. The aim of these methods is individualize the intraoperative and postoperative opioid dose3. In this context, it has been suggested that the Surgical Pleth Index (SPI) method can be used in the evaluation of the analgesic component of anesthesia.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 to 65 years
* ASA physical status I-III
* Who received craniotomy and intracranial mass excision
Exclusion Criteria:
* Diagnosed diabetic neuropathy
* Using pacemaker
* Needing vasoactive agent during the observation
* Using ketamine
* Using agents such as beta-blockers, beta-agonists, sympatholytic agents, atropine, neostigmine that will affect the sympatho-vagal balance during the observation period
* The patients who could not provide sufficient cooperation for scoring were not included in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial monitored something called the Surgical Pleth Index during surgery to see if it predicts postoperative pain — can you explain what that index measures and whether that kind of monitoring is used during my procedure?
2Since this study is completed, have the results shown that tracking the Surgical Pleth Index actually helps doctors give better pain relief after surgery, and would those findings change how my pain management is handled?
3The trial focused on acute postoperative pain and how much pain medication patients needed after surgery — based on what this study found, is there a more tailored approach to managing my pain in the recovery room that my care team might consider?
4This was listed as Phase NA, which often means it was an observational or monitoring study rather than a treatment trial — does that mean patients in this study received standard care, and how does that compare to what I would receive?
5Are there other approaches or studies my care team is already using to predict and manage my postoperative pain, and would the findings from this completed trial be relevant to my specific surgery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.