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
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 72
- Locations
- 1
Study Overview
Brief Summary
This study will evaluate the effect of adding dexmedetomidine to bupivacaine compared to ketamine in the caudal block on perioperative analgesia in patients undergoing lumbosacral surgeries under general anesthesia.
Detailed Description
Preoperative settings:
All participants will be clinically assessed (history, duration of illness and medications especially analgesic history) and routine preoperative investigations will be done; CBC, Coagulation profile, liver function tests, kidney function tests, random blood sugar and ECG.
Also preoperatively, participants will be trained how to use visual analog scale (VAS) to assess pain severity. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).
Intraoperative settings and technique:
On arrival of the participant to the operative room, standard monitoring including electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.