Dexmedetomidine or ketamine added to bupivacaine for caudal pain relief in lumbosacral surgery
Official title: Effect of Adding Dexmedetomidine Versus Ketamine to Bupivacaine in Fluoroscopy Guided Caudal Analgesia for Lumbosacral Surgeries Under General Anaesthesia; a Randomised Controlled Double Blinded Study
Run by Ain Shams University · NCT07573969 · Data updated 2026-11-12
This trial will test whether adding dexmedetomidine or ketamine to bupivacaine in a fluoroscopy-guided caudal block improves perioperative pain control for adults having lumbosacral surgery under general anesthesia.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | May 2026 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT07573969 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21–60 years with ASA physical status I–II who are scheduled for lumbosacral surgery under general anesthesia and have no contraindication to regional anesthesia.
✕Probably not a fit
Patients who are pregnant or lactating, have coagulopathy or local infection, recent analgesic abuse, allergy to study drugs, significant cognitive impairment, or ASA status above II are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults scheduled for lumbosacral surgery receive standard preoperative assessment and training on the visual analog scale, then undergo general anesthesia with a fluoroscopy-guided caudal block. Participants are assigned to one of three groups: bupivacaine 0.125% alone, bupivacaine 0.125% plus dexmedetomidine 2 µg/kg, or bupivacaine 0.125% plus ketamine 1 mg/kg. Pain scores and perioperative analgesic requirements are recorded using VAS and routine monitoring. Routine labs and standard intraoperative monitoring are performed per protocol.
Why it matters
Potential benefit: If successful, the tested adjunct could provide longer or better pain relief after lumbosacral surgery and reduce the need for systemic opioids.
How similar studies have gone: Previous clinical work has often shown that adding dexmedetomidine to local anesthetics prolongs regional block analgesia, while results for caudal ketamine have been more variable.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 21-60 years. * Sex: Both sexes. * American Society of Anesthesiologists (ASA) Physical Status Class-I and II. * Scheduled for lumbosacral surgery under General Anesthesia. Exclusion Criteria: * Declining to give written informed consent or patients with significant cognitive dysfunction that hinders informed consent. * History of allergy to the medications used in the study. * Contraindications to regional anesthesia (including coagulopathy and local infection). * History of recent analgesic intake or abuse. * Pregnancy or lactating mothers.
Where it's running
-
Ain Shams University hospitals
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Salma Ayman Abdulazeem, MSc
- Email: Salmaaymen0103389@med.asu.edu.eg
- Phone: +201285665828
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.