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

NCT05919173 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: SIUT-ERC-2021/A-258
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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

  24 hour post operatively

Study Arms (2)

Bupivacaine 0.25%

EXPERIMENTAL

Bupivacaine 0.25% Dose: 1mL/kg body weight

Drug: Bupivacaine Hydrochloride 0.25% Injection Solution

Bupivacaine+DEX

EXPERIMENTAL

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

Drug: Bupivacaine Hydrochloride 0.25% Injection plus Dexmedetomidine 1 microgram/kg body weight

Interventions

Bupivacaine Hydrochloride 0.25% Injection Solution DRUG

Bupivacaine Hydrochloride 0.25% Injection Dose: 1mL/kg (milliliter per kilogram body weight)

Bupivacaine 0.25%

Bupivacaine Hydrochloride 0.25% Injection plus Dexmedetomidine 1 microgram/kg body weight DRUG

Bupivacaine HCL 0.25% Injection plus Dexmedetomidine 1micro/kg Dose: 1 mL/kg (milliliter per kilogram body weight)

Bupivacaine+DEX

Eligibility Criteria

• Age: 2 Months - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ASA 1 \& 2
• elective per-urethral cystolithotripsy

You may not qualify if:

• 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

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

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

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Injections

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Ali A Lanewala, MD, PhD

  Sindh Institute of Urology & Transplantation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: comparative study

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: July 10, 2021
• Primary Completion: November 15, 2021
• Study Completion: November 20, 2021
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)