Dexmedetomidine as an adjuvant to bupivacaine in caudal analgesia in children.
Vigya Goyal, Jyotsna Kubre, Krishnaprabha Radhakrishnan
https://pubmed.ncbi.nlm.nih.gov/27212752Actively Recruiting
Phase 3
Age: 21Years - 60Years
All Genders
ID07573969
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
Led by Ain Shams University · Updated on 2026-05-07
72
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of adding dexmedetomidine or ketamine to bupivacaine in caudal blocks on pain relief during and after lumbosacral surgeries performed under general anesthesia. This phase 3 randomized controlled trial aims to compare how these combinations affect perioperative pain management. Participants will receive one of three treatments during surgery: plain bupivacaine alone, bupivacaine with dexmedetomidine, or bupivacaine with ketamine, all given via a fluoroscopy-guided caudal block. Standard general anesthesia and monitoring will be applied, with detailed procedures for administering the block under imaging guidance. Postoperative pain will be managed with scheduled IV ketorolac and paracetamol, with morphine available as rescue medication if pain scores are high. Participants will be assessed before surgery with medical history and routine tests, and trained to use a pain scale. During surgery and recovery, vital signs will be closely monitored. Pain intensity will be recorded at several intervals up to 24 hours post-surgery, along with opioid use and side effects like nausea or low blood pressure. The main outcome is the duration of pain relief when pain reaches a set level. Data collection is blinded to treatment allocation to ensure unbiased results.
CONDITIONS
Brief Title
Adding Dexmedetomidine Versus Ketamine to Bupivacaine in Fluoroscopy Guided Caudal Analgesia for Lumbosacral Surgeries
Who Can Participate
Age: 21Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 21 to 60 years
- Both males and females
- Physical status classified as ASA Class-I or II
- Scheduled for lumbosacral surgery under general anesthesia
You will not qualify if you...
- Declining to give written informed consent or having significant cognitive dysfunction
- Allergy to any study medications
- Contraindications to regional anesthesia such as blood clotting problems or local infection
- Recent use or abuse of analgesic medications
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for clinical assessment and routine preoperative investigations
Treatment
Duration - Surgery day
Participants receive general anesthesia and a fluoroscopy guided caudal analgesia with either bupivacaine alone or combined with dexmedetomidine or ketamine during lumbosacral surgery.
1 intraoperative visit and monitoring during surgery
Post-operative Follow-up
Duration - 24 hours post-surgery
Participants are monitored postoperatively for pain severity using the visual analog scale and receive scheduled analgesics. Rescue analgesia is provided as needed. Vital signs and side effects are regularly assessed in the first 24 hours after surgery.
Multiple assessments at 0, 2, 4, 6, 8, 12, 16 and 24 hours postoperatively in PACU and surgical ward
Trial Site Locations
Total: 1 location
1
Ain Shams University hospitals
Cairo, Egypt
Actively Recruiting
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Research Team
S
Salma Ayman Abdulazeem, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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S L Solanki, N Bharti, Y K Batra...
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