Clinical trial NCT05919173: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Lead sponsor: Sindh Institute of Urology and Transplantation
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparative study
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Post operative Pain
timeFrame: 24 hour post operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sindh Institute of Urology and Transplantation. Department of Anaesthesia and Surgical Intensive Care Units
state: Sindh
Study officials:
affiliation: Sindh Institute of Urology & Transplantation
name: Ali A Lanewala, MD, PhD
role: STUDY_DIRECTOR
References: