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

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride 0.25% Injection Solution
Bupivacaine Hydrochloride 0.25% Injection plus Dexmedetomidine 1 microgram/kg body weight
Sponsored by
Sindh Institute of Urology and Transplantation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Operative Pain

Eligibility Criteria

2 Months - 7 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sindh Institute of Urology and Transplantation. Department of Anaesthesia and Surgical Intensive Care Units

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Bupivacaine 0.25%

Bupivacaine+DEX

Arm Description

Bupivacaine 0.25% Dose: 1mL/kg body weight

Bupivacaine 0.25% plus Dexmedetomidine 1microgram/kg Dose: 1mL/kg

Outcomes

Primary Outcome Measures

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 comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain

Secondary Outcome Measures

Full Information

First Posted
June 15, 2023
Last Updated
July 8, 2023
Sponsor
Sindh Institute of Urology and Transplantation
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1. Study Identification

Unique Protocol Identification Number
NCT05919173
Brief Title
Comparison Between Bupivacaine and Bupivacaine With Dexmedetomidine in Caudal Block for Post Operative Pain Control
Official Title
UROLOGICAL SURGERIES IN CHILDREN: Comparison Between 0.25% Bupivacaine and 0.25% Bupivacaine withDexmedetomidine in the Caudal Block
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 10, 2021 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sindh Institute of Urology and Transplantation

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
comparative study
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine 0.25%
Arm Type
Experimental
Arm Description
Bupivacaine 0.25% Dose: 1mL/kg body weight
Arm Title
Bupivacaine+DEX
Arm Type
Experimental
Arm Description
Bupivacaine 0.25% plus Dexmedetomidine 1microgram/kg Dose: 1mL/kg
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride 0.25% Injection Solution
Intervention Description
Bupivacaine Hydrochloride 0.25% Injection Dose: 1mL/kg (milliliter per kilogram body weight)
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride 0.25% Injection plus Dexmedetomidine 1 microgram/kg body weight
Intervention Description
Bupivacaine HCL 0.25% Injection plus Dexmedetomidine 1micro/kg Dose: 1 mL/kg (milliliter per kilogram body weight)
Primary Outcome Measure Information:
Title
Post operative Pain
Description
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 comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain
Time Frame
24 hour post operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali A Lanewala, MD, PhD
Organizational Affiliation
Sindh Institute of Urology & Transplantation
Official's Role
Study Director
Facility Information:
Facility Name
Sindh Institute of Urology and Transplantation. Department of Anaesthesia and Surgical Intensive Care Units
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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