Adding Dexmedetomidine Versus Ketamine to Bupivacaine in Fluoroscopy Guided Caudal Analgesia for Lumbosacral Surgeries

ConditionPerioperative Analgesia

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age21-60

SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Group C (plain bupivacaine (0.125%))
Drug
The patients will receive 20ml plain bupivacaine (0.125%) in the caudal block
Group D (plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine)
Drug
The patients will receive 20ml plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine in the caudal block
Group K (plain bupivacaine (0.125%) + 1mg/kg ketamine)
Drug
The patients will receive 20ml plain bupivacaine (0.125%) + 1mg/kg ketamine in the caudal block

Treatment groups

72 Participants

are divided into 3 treatment groups

Group A: ControlActive comparator 1 intervention

Group B: DexmedetomidineActive comparator 1 intervention

Group C: KetamineActive comparator 1 intervention

Trial outcomes

Primary outcomes

Duration of postoperative analgesia when VAS score ≥ 3.

Duration of postoperative analgesia (the time from the end of giving the caudal analgesia to the first given dose of morphine) when VAS score ≥ 3.

Time frame

Immediately after giving the caudal block and up to 24 hours postoperatively.

Secondary outcomes

The total dose of used morphine postoperatively/patient (rescue analgesia) for first 24 hours, PONV and hemodynamic effects.

Time frame

First 24 hours postoperative.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

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