Comparison of two approaches of continuous brachial plexus block among children undergoing elbow, forearm and hand surgeries.

Phase 2

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/10/058720
• Lead Sponsor: CMC Vellore Hospital and College

Brief Summary

Infraclavicular brachialplexus block is a preferred regional anaesthetic modality in elbow, forearm andhand surgeries in pediatric patients. The conventional approach toinfraclavicular block by using ultrasound is performed in supine position witharm abducted to 90 degrees and the needle is inserted from cranial to caudaldirection at a point 1cm below and 1cm lateral to midpoint of clavicle throughwhich the catheter is inserted and left insitu, the complications of theseapproach are vessel puncture (2-33%), neurological injuries and pneumothorax.This study aims at an alternative approach to the brachial plexus block whichtargets the brachial plexus components at the costoclavicular level and isequally effective. The neurovascular bundle will be approached from theinferolateral aspect. This will be achieved by the anesthesiologist standingfacing the head end of the patient and the needle will be inserted from caudalto cranial direction. Pediatric patients undergoing elbow and forearm surgerywill be recruited. The study participants will be randomly assigned to theconventional or new approach and the patients will be masked about theallocation. The random allocation will be done using sealed envelopes whichwill be opened just before painting and draping the patient for nerve block.Information on pain score in post operative period in first 6hrs, 24 and 48hours will be measured using FLACC pain scale. Complications like neurologicalinjury during procedure, neurological damage at 24 and 48 hours will beassessed. Amount and frequency of rescue analgesia administered will becompared. Median pain scores will be compared to test equivalence betweenapproaches. Incidence of complications and mean duration of analgesia will becompared using percentages and measures of central tendency respectively.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-16
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Inclusion criteria: 1)Children aged 6 months-7years undergoing elbow, forearm, and hand surgeries.
• 2)ASA 1 and ASA 2 Patients.

Exclusion Criteria

• Exclusion criteria: 1)Patients with severe systemic illness.
• 2)Patients with local infection at the injection site, bleeding diathesis.
• 3)Patients with known allergic reactions to local anesthetics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Equal efficacy of post operative analgesia using the newer approach as measured by FLACC scores	Equal efficacy of post operative analgesia using the newer approach as measured by FLACC scores

Secondary Outcome Measures

Name	Time	Method
1)Safety – significant reduction in risk of inadvertent neurovascular injury.	2)Better catheter stability & tolerance.

Trial Locations

Locations (1)

CMC Hospital VEllore; 🇮🇳 Vellore, TAMIL NADU, India

CMC Hospital VEllore

🇮🇳Vellore, TAMIL NADU, India

VIMAL B

Principal investigator

04162282105

vimale101@gmail.com