Evaluation Of Analgesic Efficacy Of Dexmedetomidine As An Adjuvant To Ropivacaine in Paravertebral Block in Renal Surgeries in Paediatric Population: A Randomized Clinical Trial

STUDY TITLE: “Evaluation of analgesic efficacy of dexmedetomidine as an adjuvant to ropivacaine in paravertebral block in renal surgeries in paediatric population: A  randomized clinical trial”

 INTRODUCTION:

Renal surgeries one of the most commonly performed surgical procedures in children are associated with significant amount of pain. Paravertebral block is an effective analgesic technique used in providing excellent intraoperative as well as postoperative analgesia in children undergoing renal surgeries. The use of ultrasound, has further improved the success rate of the block with excellent visualisation of the structures and also allowing us to visualize local anaesthetic spread. In paediatric population, dexmedetomidine has undoubtedly improved the quality of post-operative analgesia in various studies in peripheral nerve blocks and caudal epidurals.

An extensive search of literature revealed very few studies with regards to the use of dexmedetomidine in paravertebral block in paediatric renal surgeries. Hence the present study is being planned to evaluate the analgesic efficacy of ultrasound guided paravertebral block using dexmedetomidine with ropivacaine in paediatric patients undergoing renal surgeries.

 AIM:

·       Evaluation of the analgesic efficacy of dexmedetomidine in combination with ropivacaine for single-shot paravertebral block in pediatric patients undergoing renal surgeries.

OBJECTIVES:

Primary Objective:

·        To compare the time to first rescue analgesia in patients receiving paravertebral block with ropivacaine with or without dexmedetomidine after receiving general anaesthesia(GA) for renal surgeries.

Secondary objectives:

1.      To compare the postoperative pain scores in patients receiving paravertebral block with ropivacaine with or without dexmedetomidine after receiving GA for renal surgeries.

2.      To compare the incidence of any complications (hypotension, bradycardia, pneumothorax, nausea and vomiting) related to the anaesthetic techniques in the two groups.STUDY TITLE: “Evaluation of analgesic efficacy of dexmedetomidine as an adjuvant to ropivacaine in paravertebral block in renal surgeries in paediatric population: A  randomized clinical trial”

 INTRODUCTION:

Renal surgeries one of the most commonly performed surgical procedures in children are associated with significant amount of pain. Paravertebral block is an effective analgesic technique used in providing excellent intraoperative as well as postoperative analgesia in children undergoing renal surgeries. The use of ultrasound, has further improved the success rate of the block with excellent visualisation of the structures and also allowing us to visualize local anaesthetic spread. In paediatric population, dexmedetomidine has undoubtedly improved the quality of post-operative analgesia in various studies in peripheral nerve blocks and caudal epidurals.

An extensive search of literature revealed very few studies with regards to the use of dexmedetomidine in paravertebral block in paediatric renal surgeries. Hence the present study is being planned to evaluate the analgesic efficacy of ultrasound guided paravertebral block using dexmedetomidine with ropivacaine in paediatric patients undergoing renal surgeries.

 AIM:

·       Evaluation of the analgesic efficacy of dexmedetomidine in combination with ropivacaine for single-shot paravertebral block in pediatric patients undergoing renal surgeries.

OBJECTIVES:

Primary Objective:

·        To compare the time to first rescue analgesia in patients receiving paravertebral block with ropivacaine with or without dexmedetomidine after receiving general anaesthesia(GA) for renal surgeries.

Secondary objectives:

1.      To compare the postoperative pain scores in patients receiving paravertebral block with ropivacaine with or without dexmedetomidine after receiving GA for renal surgeries.

2.      To compare the incidence of any complications (hypotension, bradycardia, pneumothorax, nausea and vomiting) related to the anaesthetic techniques in the two groups.

MATERIALS AND METHODS:

Study Design: Hospital-based, prospective, randomized, double-blind controlled study.

Study Period: April 2024 to December 2024

Place of Study: Department of Anaesthesia, Chacha Nehru Bal Chikitsalaya, New Delhi

Inclusion Criteria:

1.     Children aged 2-12 years undergoing renal surgeries.

2.     ASA  physical status grade I and II

Exclusion Criteria:

1.     Any contraindications for paravertebral block (infection at the injection site, kyphoscoliosis, history of bleeding disorders, patients on anticoagulants, history of drug allergy.)

2.     Patients taking chronic analgesics.

 Methodology: 40 patients will be allocated in two groups of 20 each.

Group A         Patients will receive ultrasound guided paravertebral block with 0.2% ropivacaine 0.5 ml/kg with 0.5 ml normal saline.

Group B Patients will receive ultrasound guided paravertebral block with 0.2% ropivacaine 0.5 ml/kg + 1 mcg/kg of dexmedetomidine in a volume of 0.5 ml.

We will compare the two groups in terms of time to first analgesic request, pain scores and the total consumption of analgesics in the postoperative period for 24 hours.

Outcomes Measures:

Primary Outcome:

Time to first analgesic requirement in the postoperative period.

Secondary Outcome:

1. Total consumption of analgesics in postoperative period for 24 hours.

2. Intraoperative opioid consumption.

3. Pain scores in the postoperative period for 24 hours.

4. Satisfaction score for pain relief - good /average /poor.

5. Untoward effects if any - hypotension, bradycardia, sedation, vomiting, pneumothorax.

Statistical Tests:

Statistical analysis will be performed by the freely available statistics software on the internet. Normally distributed continuous variables will be compared using the unpaired t test, whereas the Mann-Whitney U test will be used for those variables that will not be normally distributed. Categorical variables will be analysed using either the chi square test or Fisher’s exact test. P<0.05 will be considered statistically significant.