A clinical trial to study the effect of addition of drug dexmedetomidine on pain relief for surgeries on the upper limb in children

Not yet recruiting

• Conditions: Fracture of lower end of humerus, (2) ICD-10 Condition: Q704||Polysyndactyly, unspecified, (3) ICD-10 Condition: S525||Fracture of lower end of radius,

• Registration Number: CTRI/2020/05/025284
• Lead Sponsor: Chacha Nehru bal Chikitsalaya Hospital

Brief Summary

**STUDY TITLE:** “**Analgesic efficacy of Dexmedetomidine as an adjunct in Ultrasound guided Supraclavicular block for Paediatric Upper Limb Surgeries : a randomised double blind controlled study**â€

**INTRODUCTION:** Upper limb surgeries have been performed safely in supraclavicular block for decades as a sole anaesthetic technique or in combination with sedation and general anaesthesia. The use of  ultrasound has improved the success rate of the block with excellent visualisation of the structures. 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 no study with regards to the use of dexmedetomidine in supraclavicular block in paediatric patients. Hence the present study is being planned to evaluate the analgesic efficacy of dexmedetomidine as an adjuvant to bupivacaine in ultrasound guided supraclavicular block in paediatric patients undergoing upper limb surgeries.

**AIM OF THE STUDY:** To evaluate the analgesic efficacy of dexmedetomidine in combination with bupivacaine  in ultrasound guided supraclavicular nerve block in paediatric upper limb surgeries.

**PRIMARY OBJECTIVE -**

To compare the duration of analgesia in patients receiving general anaesthesia (GA) and supraclavicular block with dexmedetomidine and bupivacaine vs those receiving GA and supraclavicular block with bupivacaine only for paediatric upper limb surgeries.

**SECONDARY OBJECTIVES -**

1.To compare the consumption of intraoperative opioids and post operative analgesics  in    the two groups.

2.To compare the incidence of any complications related to the anaesthetic techniques in the two groups.

**MATERIALS AND METHODS:**

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

**Study Period:** May 22nd 2020 to December 2020

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

**Inclusion Criteria:**

1. Children aged 3-12 years

2. Undergoing elective upper limb surgeries

3. ASA  physical status grade I and II

**Exclusion Criteria:**

1. Any contraindications for supraclavicular block (infection at the injection site,

history of bleeding disorders, patients on anticoagulants, history of drug allergy).

2. Patients undergoing bilateral surgery on upper limbs in the same setting.

3. Patients taking chronic analgesics.

 **Methodology****:** 50 patients will be allocated in two groups of 25 each.

**Group A** patients will receive ultrasound guided supraclavicular block with 0.25% bupivacaine 0.3 ml/kg with 0.5 ml normal saline.

 **Group B** patients will receive ultrasound guided supraclavicular block with 0.25% bupivacaine 0.3 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 request in the postoperative period

**SECONDARY OUTCOMES** :

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

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

 **Statistical Tests:** Statistical analysis will be performed by the SPSS program for Windows, version 17.0(SPSS, Chicago, Illinois). 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. P<0.05 will be considered statistically significant.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-05-20
• Study Start: 2020-05-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Children aged 3-12 years 2.
• Undergoing elective upper limb surgeries 3.
• ASA physical status grade I and II.

Exclusion Criteria

• Any contraindications for supraclavicular block (infection at the injection site,history of bleeding disorders, patients on anticoagulants, history of drug allergy).
• Patients undergoing bilateral surgery on upper limbs in the same setting.
• Patients taking chronic analgesics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first analgesic request in postoperative period	First 24 hours in postoperative period

Secondary Outcome Measures

Name	Time	Method
Total consumption of analgesics in postoperative period for 24 hours	30 mins,1 hr, 1.5 hr, 2 hrs, 4 hrs, 8 hrs, 24 hrs
Intraoperative opioid consumption	Total duration of anaesthesia
Pain scores in the postoperative period for 24 hours	30 mins,1 hr, 1.5 hr, 2 hrs, 4 hrs, 8 hrs, 24 hrs
Satisfaction score for pain relief	at the end of 24 hrs
Untoward effects if any - hypotension , bradycardia, sedation, vomiting, pneumothorax

Trial Locations

Locations (1)

Chacha Nehru Bal Chikitsalaya Hospital, Geeta Colony; 🇮🇳 East, DELHI, India

Chacha Nehru Bal Chikitsalaya Hospital, Geeta Colony

🇮🇳East, DELHI, India

Dr Bhumika Kalra

Principal investigator

9810847992

bhumikakalra@gmail.com