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

NCT ID: NCT05919173

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-10
• Study Completion Date: 2021-11-20

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Bupivacaine 0.25%

Bupivacaine 0.25% Dose: 1mL/kg body weight

Group Type: EXPERIMENTAL

Bupivacaine Hydrochloride 0.25% Injection Solution

Intervention Type: DRUG

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

Bupivacaine+DEX

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

Bupivacaine Hydrochloride 0.25% Injection Solution

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

Intervention Type: 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)

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sindh Institute of Urology and Transplantation

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shakil Malik

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali A Lanewala, MD, PhD

Role: STUDY_DIRECTOR

Sindh Institute of Urology & Transplantation

Locations

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

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

SIUT-ERC-2021/A-258

Identifier Type: -

Identifier Source: org_study_id