Comparison Between Bupivacaine and Bupivacaine With Dexmedetomidine in Caudal Block for Post Operative Pain Control

UROLOGICAL SURGERIES IN CHILDREN: Comparison Between 0.25% Bupivacaine and 0.25% Bupivacaine withDexmedetomidine in the Caudal Block

The aim of this study is to compare the duration of analgesia, sedation, and intra and postoperative hemodynamics. This drug is recently available in Pakistan. To the best of our knowledge, no published data is available in this respect in Pakistan, so this study would in turn help to fill the gap in knowledge in low-resource settings/emerging economy.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride 0.25% Injection Solution; Drug: Bupivacaine Hydrochloride 0.25% Injection plus Dexmedetomidine 1 microgram/kg body weight

Detailed Description

Postoperative pain is an annoying subjective sensation for both children and their parents. Almost 80% of the patients undergoing surgery experience postoperative pain, and 80% of them reported moderate to severe pain intensity. Management of postoperative pain has become a major concern in pediatrics. Results of many studies in different countries show that postoperative pain in children is inadequate. Lee et al showed that one of the main reasons for inadequate treatment of postoperative pain in children is difficulties with pain assessment and concerns related to the side effects of opioid analgesics.

The regional anesthetic technique significantly decreases postoperative pain and systemic analgesic requirements. Caudal block, usually combined with general anesthetic technique is one of the most popular, reliable, and safe anesthesia techniques for abdominal and lower limb surgeries in children but the main disadvantage of caudal analgesia is the short duration of action after a single injection.

Bupivacaine is a long-acting, reliable local anesthetic agent that is used as a caudal analgesic, but different auxiliary agents need to be co-administered to improve its analgesic efficiency. Various additives used in the past to increase the pain-free period postoperatively and to decrease the analgesic requirement such as midazolam neostigmine, ketamine, clonidine, and dexmedetomidine.

Dexmedetomidine is a potent and highly selective alpha 2 adrenergic agonists that has been described as safe and effective in many anesthetic applications and analgesic techniques. In contrast to other agents, it has sympatholytic, analgesic, and sedative effects, and is randomly free from side effects except for manageable hypotension and bradycardia.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Sindh Institute of Urology and Transplantation. Department of Anaesthesia and Surgical Intensive Care Units

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• ASA 1 & 2
• elective per-urethral cystolithotripsy

Exclusion Criteria:

• History of developmental delay or mental retardation
• Known or suspected coagulopathy
• Known allergy to any of the study drugs
• Any signs of infection at the site of the proposed caudal block
• Any caudal anatomical deformity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivacaine 0.25%; Bupivacaine 0.25% Dose: 1mL/kg body weight	Drug: Bupivacaine Hydrochloride 0.25% Injection Solution; Bupivacaine Hydrochloride 0.25% Injection Dose: 1mL/kg (milliliter per kilogram body weight)
Experimental: Bupivacaine+DEX; Bupivacaine 0.25% plus Dexmedetomidine 1microgram/kg Dose: 1mL/kg	Drug: Bupivacaine Hydrochloride 0.25% Injection plus Dexmedetomidine 1 microgram/kg body weight; Bupivacaine HCL 0.25% Injection plus Dexmedetomidine 1micro/kg Dose: 1 mL/kg (milliliter per kilogram body weight)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative Pain	face, legs, activity, cry, and consolability (FLACC) behavioral pain scale; Each category is scored on the 0-2 scale which results in a total score of 0-10.; Assessment of FLACC Pain Score:0 = Relaxed and comfortable1-3 = Mild discomfort4-6 = Moderate pain7-10 = Severe discomfort/pain	24 hour post operatively

Collaborators and Investigators

• Sponsor: Sindh Institute of Urology and Transplantation
• Investigators: Study Director: Ali A Lanewala, MD, PhD, Sindh Institute of Urology & Transplantation

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2021
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): November 20, 2021

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 8, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: SIUT-ERC-2021/A-258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes