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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05919173
• Other study ID #: SIUT-ERC-2021/A-258
• Status: Completed
• Phase: Phase 4
• Start date: July 10, 2021
• Est. completion date: November 20, 2021

Study information

• Verified date: July 2023
• Source: Sindh Institute of Urology and Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 20, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

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

Locations

Country	Name	City	State
Pakistan	Sindh Institute of Urology and Transplantation. Department of Anaesthesia and Surgical Intensive Care Units	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Sindh Institute of Urology and Transplantation

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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