Analgesic Requirements for Lumbar Fixation With General Anaesthesia Versus Continuous Caudal Epid… (NCT06929611) | Clinical Trial Compass
CompletedNot Applicable
Analgesic Requirements for Lumbar Fixation With General Anaesthesia Versus Continuous Caudal Epidural
Egypt60 participantsStarted 2024-01-15
Plain-language summary
In this clinical study, the investigators will justify the current practice of combined continuous caudal epidural with general anaesthesia in adult patients undergoing lumbar fixation versus general anaesthesia. Furthermore, the investigators will determine the analgesic requirement, rescue analgesia, hemodynamic changes and possible complications with continuous caudal epidural analgesia.
Who can participate
Age range
21 Years – 60 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:
* Age group: Adult patients from age of 21 years to 60 years
* Sex: Both sexes.
* American Society Association Classification (ASA): patients with ASA classification I, II.
* Elective lumbar fixation surgeries.
Exclusion Criteria:
* Patients refuse to give informed consent.
* Patients younger than 21 or older than 60.
* History of bupivacaine allergy.
* Emergency surgeries.
* Patients who underwent previous spine surgeries of any cause.
* Infection at the site of injection.
* Coagulopathy (acquired, induced, genetic).
* ASA Classification: ASA III, IV.
* Severe aortic stenosis, severe mitral stenosis, hypertrophic obstructive cardiomyopathy.
* Severe hypovolemia, Severe uncorrected anemia.
* Increased intra-cranial pressure (i.e., brain tumor or recent head injury).
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
Determining the total amount of fentanyl that will be consumed as intra operative analgesia
Timeframe: during intraoperative period (from induction of anesthesia until recovery from general anaesthesia)