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

NCT07573969 | Recruiting Phase 3 DMC

• 1 other identifier: FMASU MD290/2025
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Analgesia

Keywords

Caudal analgesia; Adult caudal blocks; Lumbosacral surgeries; Caudal ketamine; Caudal dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

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

  First 24 hours postoperative.

Study Arms (3)

Control

ACTIVE COMPARATOR

The patients will receive 20ml plain bupivacaine (0.125%) in the caudal block

Drug: Group C (plain bupivacaine (0.125%))

Dexmedetomidine

ACTIVE COMPARATOR

The patients will receive 20ml plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine in the caudal block

Drug: Group D (plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine)

Ketamine

ACTIVE COMPARATOR

The patients will receive 20ml plain bupivacaine (0.125%) + 1mg/kg ketamine in the caudal block

Drug: Group K (plain bupivacaine (0.125%) + 1mg/kg ketamine)

Interventions

Group C (plain bupivacaine (0.125%)) DRUG

The patients will receive 20ml plain bupivacaine (0.125%) in the caudal block

Control

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

Ketamine

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

Dexmedetomidine

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

RECRUITING

Related Publications (19)

• Goyal V, Kubre J, Radhakrishnan K. Dexmedetomidine as an adjuvant to bupivacaine in caudal analgesia in children. Anesth Essays Res. 2016 May-Aug;10(2):227-32. doi: 10.4103/0259-1162.174468.

  PMID: 27212752 BACKGROUND

• Wiegele M, Marhofer P, Lonnqvist PA. Caudal epidural blocks in paediatric patients: a review and practical considerations. Br J Anaesth. 2019 Apr;122(4):509-517. doi: 10.1016/j.bja.2018.11.030. Epub 2019 Feb 1.

  PMID: 30857607 BACKGROUND

• Barham G, Hilton A. Caudal epidurals: the accuracy of blind needle placement and the value of a confirmatory epidurogram. Eur Spine J. 2010 Sep;19(9):1479-83. doi: 10.1007/s00586-010-1469-8. Epub 2010 May 29.

  PMID: 20512512 BACKGROUND

• Beyaz SG, Tokgoz O, Tufek A. Caudal epidural block in children and infants: retrospective analysis of 2088 cases. Ann Saudi Med. 2011 Sep-Oct;31(5):494-7. doi: 10.4103/0256-4947.84627.

  PMID: 21911987 BACKGROUND

• Mossetti V, Vicchio N, Ivani G. Local anesthetis and adjuvants in pediatric regional anesthesia. Curr Drug Targets. 2012 Jun;13(7):952-60. doi: 10.2174/138945012800675713.

  PMID: 22512395 BACKGROUND

• Bajwa SJ, Bajwa SK, Kaur J, Singh G, Arora V, Gupta S, Kulshrestha A, Singh A, Parmar S, Singh A, Goraya S. Dexmedetomidine and clonidine in epidural anaesthesia: A comparative evaluation. Indian J Anaesth. 2011 Mar;55(2):116-21. doi: 10.4103/0019-5049.79883.

  PMID: 21712865 BACKGROUND

• Solanki SL, Bharti N, Batra YK, Jain A, Kumar P, Nikhar SA. The analgesic effect of intrathecal dexmedetomidine or clonidine, with bupivacaine, in trauma patients undergoing lower limb surgery: a randomised, double-blind study. Anaesth Intensive Care. 2013 Jan;41(1):51-6. doi: 10.1177/0310057X1304100110.

  PMID: 23362890 BACKGROUND

• Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents. doi: 10.1213/01.ane.0000261521.52562.de.

  PMID: 17513626 BACKGROUND

• Sekar C, Rajasekaran S, Kannan R, Reddy S, Shetty TA, Pithwa YK. Preemptive analgesia for postoperative pain relief in lumbosacral spine surgeries: a randomized controlled trial. Spine J. 2004 May-Jun;4(3):261-4. doi: 10.1016/j.spinee.2003.11.009.

  PMID: 15125846 BACKGROUND

• Goyal V, Kubre J, Radhakrishnan K.: Dexmedetomidine as an adjuvant to bupivacaine in caudal analgesia in children. Anesth Essays Res. 2016 May-Aug;10(2):227-32.

  BACKGROUND

• Wiegele M, Marhofer P, Lönnqvist PA.: Caudal epidural blocks in paediatric patients: a review and practical considerations. Br J Anaesth. 2019 Apr;122(4):509-517.

  BACKGROUND

• Mossetti V., Vicchio N., Ivani G.: Local anesthetics and adjuvants in pediatric regional anesthesia. Curr Drug Targets. 2012;13:952-960.

  BACKGROUND

• Sabbar S, Zamir AK, Khan FA: Caudal ketamine with bupivacaine and bupivacaine alone for postoperative analgesia in paediatric inguino-scrotal surgeries. Med Channel. 2009; 4:207-210.

  BACKGROUND

• Bajwa SJS, Bajwa SK: Dexmedetomidine and Clonidine in Epidural anaesthesia: A comparative evaluation. Indian Journal of Anaesthesia. 2011; 55:116-21.

  BACKGROUND

• Solanki SL, Bharti N, Batra YK, et al.: The analgesic effect of intrathecal dexmedetomidine or clonidine, with bupivacaine, in trauma patients undergoing lower limb surgery: a randomized, double-blind study. Anaesth Intensive Care. 2013; 41(1):51-6.

  BACKGROUND

• Vetter TR, Carvallo D, Johnson JL, et al.: A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007; 104(6):1356-1363.

  BACKGROUND

• Beyaz SG, Tokgoz O and Tufek A.: Caudal epidural block in children and infants: retrospective analysis of 2088 cases. Ann Saudi Med. 2011; 31(5):494-497.

  BACKGROUND

• Barham G and Hilton A.: the accuracy of blind needle placement and the value of a confirmatory epidurogram. EuropeanSpineJournal. 2010; 19(9):1479-1483.

  BACKGROUND

• Sekar C, Rajasekaran S, Kannan R, et al.: Preemptive analgesia for postoperative pain relief in lumbosacral spine surgeries: a randomized controlled trial. Spine J. 2004;4(3):261-264.

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Dexmedetomidine; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Salma Ayman Abdulazeem, MSc

CONTACT

+201285665828; Salmaaymen0103389@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

EG (1)