Partial Scalp Block in Posterior Fossa Surgery (NCT04955236) | Clinical Trial Compass
CompletedPhase 1
Partial Scalp Block in Posterior Fossa Surgery
Egypt40 participantsStarted 2021-07-14
Plain-language summary
Pain in patients undergoing posterior fossa surgery is regarded as more intense when compared to pain in patients undergoing supratentorial cranial surgeries. It may result in a rise in blood pressure and heart rate leading to serious effects as increased intracranial pressure and intracranial hemorrhage. For a long time, the control of pain has been the role of opioids. However, the use of opioids is not devoid of side effects. Hence, combining other techniques as partial scalp block with general anesthesia may be beneficial in controlling hemodynamics and decreasing the amount of opioids used without sacrificing the good quality of analgesia and anesthesia.
Who can participate
Age range
21 Years – 55 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:
* Physical status ASA I and ASA ll.
* Males and females between the ages of 21 and 55.
* Patients undergoing posterior fossa Surgeries.
* Patients with GCS ≥14
* Patients undergoing operation in prone position
Exclusion Criteria:
* Patient refusal.
* Patients with a history of allergy to opioids or local anesthetics
* GCS (Glasgow coma score) ≤13 upon emergence from anesthesia.
* Patients who will need post-operative ventilation
* Patients who had previous craniotomies
* Patients with contraindication to regional anaesthesia e.g.: local sepsis,
* Patients with pre-existing peripheral neuropathies and coagulopathy.
* Patients who will develop intraoperative surgical complications
* Operations lasting more than 5 hours.
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
Systolic blood pressure at time of skin incision
Timeframe: During surgery, 1 min after skin incision