Dexmedetomidine or ketamine added to bupivacaine for caudal pain relief in lumbosacral surgery
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
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 |
| Enrollment | 72 (estimated) |
| Ages | 21 Years to 60 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07573969 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cairo
- Ain Shams University hospitals — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Salma Ayman Abdulazeem, MSc
- Email: Salmaaymen0103389@med.asu.edu.eg
- Phone: +201285665828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.