Preoperative Block for Anterior Cervical Spine Surgery (NCT06867510) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Preoperative Block for Anterior Cervical Spine Surgery
Egypt90 participantsStarted 2025-04-01
Plain-language summary
The purpose of this clinical trial study is to compare the analgesic effects of ultrasound-guided intermediate cervical plexus block Versus cervical erector spinae block in patients undergoing anterior cervical spine surgery.
* The main questions it aims to answer are:
* The primary outcome will be recording postoperative pain intensity using Numerical Rating Scale (NRS).
* The secondary outcomes will be measuring the performance time, onset of the sensory block, intraoperative fentanyl consumption, time to the first call for rescue analgesia (nalbuphine), postoperative total nalbuphine consumption, and postoperative complications such as nausea, vomiting, hypotension, and bradycardia.
* We will compare two blocks to a placebo.
* Participants will:
* undergo ultrasound-guided intermediate cervical plexus block or cervical erector spinae block or a placebo
* Be assessed for pain after 2 h, 4 h, 6 h, 12 h, and 24 h postoperatively
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:
* Both sex
* Age: between 21 and 60 years
* Physical status: belongs to American Society of Anesthesiologists (ASA) I, II
* Body mass index (BMI): from 25 to 30 kg/m2
* Type of surgery: elective anterior cervical spine surgery under general anesthesia
Exclusion Criteria:
* Refusal of participation.
* local infection at the puncture site.
* Mental or physical disability.
* History of allergy to study drugs (bupivacaine, fentanyl).
* Hematological disorders including coagulation abnormalities.
* Severe hepatic or kidney impairment.
* Chronic pain.
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
change in postoperative pain intensity using Numerical Rating Scale