When to Block? Timing of Scalp Block in Craniotomy (NCT07043621) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
When to Block? Timing of Scalp Block in Craniotomy
Turkey (Türkiye)60 participantsStarted 2025-06
Plain-language summary
This study aims to evaluate the effect of scalp block timing-whether administered preoperatively or postoperatively-on postoperative recovery quality in patients undergoing craniotomy. The recovery quality will be assessed using the validated Quality of Recovery-40 (QoR-40) questionnaire. A total of 60 patients, aged 18-80 years, classified as ASA I-III and with a Glasgow Coma Scale (GCS) score of 15 upon admission to the recovery unit, will be enrolled. The primary outcome is the QoR-40 score. Secondary outcomes include hemodynamic changes and pain intensity measured by the Visual Analog Scale (VAS).
Who can participate
Age range
18 Years – 80 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:
* Patients aged between 18 and 80 years.
* Scheduled for craniotomy under general anesthesia.
* ASA physical status classification I to III.
* Glasgow Coma Scale (GCS) score of 15 at the time of emergence from anesthesia.
* Provide informed consent to participate in the study.
Exclusion Criteria:
* Chronic use of analgesic medications prior to surgery.
* Glasgow Coma Scale (GCS) score below 15 postoperatively.
* Allergy or hypersensitivity to local anesthetics or opioids used in the study.
* Contraindications for scalp block or patient-controlled analgesia.
* Patients with severe hepatic, renal, or cardiac dysfunction.
* Patients unable to comprehend or complete the QoR-40 questionnaire.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
Quality of Recovery Score
Timeframe: The observation period extended from the beginning of surgery until 24 hours postoperatively.