Comparison of performance of ultrasound guided costoclavicular and supraclavicular brachial plexus blocks in paediatric patients undergoing upper limb surgeries
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Amrita Chatterjee
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- To compare the costoclavicular and supraclavicular brachial plexus blocks in terms of performance time.
Overview
Brief Summary
Title:
Comparison of Performance of Ultrasound-Guided Costoclavicular and Supraclavicular Brachial Plexus Blocks in Paediatric Patients Undergoing Upper Limb Surgeries
Candidate:
Dr. Amrita Chatterjee
Postgraduate Resident, Department of Anaesthesia and Intensive Care
Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi
Supervisor: Dr. Abhishek Verma, MD
Professor, Department of Anaesthesia and Intensive Care
Background and Rationale:
Ultrasound-guided regional anaesthesia provides superior peri-operative analgesia and reduces opioid use in paediatric upper-limb surgeries. The supraclavicular brachial plexus block (SCB), though widely practiced, carries risks such as pneumothorax and phrenic nerve palsy. The costoclavicular brachial plexus block (CCB), a novel infraclavicular approach, offers potential advantages of safety, faster performance, and reliable spread of local anaesthetic due to the compact arrangement of cords. However, evidence in the paediatric population remains limited, warranting comparative evaluation.
Research Question:
Is the ultrasound-guided costoclavicular block comparable to the supraclavicular block in terms of performance time in paediatric patients undergoing upper-limb surgery?
Hypothesis:
The ultrasound-guided costoclavicular block is comparable to the supraclavicular block regarding block performance time.
Aim:
To compare the costoclavicular and supraclavicular approaches of brachial plexus block with respect to block performance in paediatric upper-limb surgeries.
Objectives:
Primary: Compare the performance time between costoclavicular and supraclavicular blocks.
Secondary:
Assess block success rate.
Compare postoperative pain using the CHEOPS score at 2, 4, 6, and 24 hours.
Evaluate diaphragmatic excursion pre- and post-operatively.
Record time to first rescue analgesia.
Study Design:
Type: Prospective, randomized interventional study
Setting: Department of Anaesthesia and Intensive Care, VMMC & Safdarjung Hospital, New Delhi
Duration: 18 months
Sample Size: 84 children (42 per group), calculated with 80% power and 5% significance level (based on Guzel et al., 2023).
Methodology:
Children aged 1–8 years, ASA physical status I–II, undergoing elective upper-limb surgery will be enrolled after parental consent and ethical clearance. Participants will be randomized using sealed opaque envelopes into two groups:
Group SCB: Supraclavicular approach
Group CCB: Costoclavicular approach
Blocks will be performed under ultrasound guidance following general anaesthesia, using 0.5% Ropivacaine (0.5 mL/kg). Imaging time, needling time, and total procedure time will be recorded. Pain will be assessed using CHEOPS, procedural ease and needle visibility by Likert scales, and diaphragmatic excursion by M-mode ultrasound.
Outcome Measures:
Parameter Assessment Tool / Unit
Performance Time Stopwatch (seconds)
Block Success Rate % requiring rescue analgesia
Post-operative Pain CHEOPS Score (4–13)
Diaphragmatic Excursion M-mode ultrasound
Procedural Ease 3- & 5-point Likert Scales
Statistical Analysis:
Data will be analysed using SPSS. Continuous variables will be expressed as mean ± SD and compared using t-test/ANOVA; categorical data using Chi-square/Fisher’s exact test. Correlation between variables will be analysed using Pearson/Spearman tests. Statistical significance will be set at p < 0.05.
Ethical Considerations:
The study will adhere to ICMR ethical guidelines. Institutional Ethics Committee approval and CTRI registration will be obtained. No additional financial or procedural burden will be placed on participants. Parental information sheets and informed consent forms are included in English and Hindi.
Summary:
This study aims to determine whether the costoclavicular block, a newer ultrasound-guided technique, provides a faster, safer, and equally effective alternative to the traditional supraclavicular block for providing peri-operative analgesia in paediatric upper-limb surgeries.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 1.00 Year(s) to 8.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA status I and II, scheduled to undergo upper limb surgeries.
Exclusion Criteria
- •Infection at needle insertion site.
- •Known allergy to local anaesthetics.
Outcomes
Primary Outcomes
To compare the costoclavicular and supraclavicular brachial plexus blocks in terms of performance time.
Time Frame: To compare the costoclavicular and supraclavicular brachial plexus blocks in terms of performance time at baseline during administration of block.
Secondary Outcomes
- Assess block success rate (surgical anaesthesia without rescue analgesia)(At the time of surgical incision.)
- Comparing postoperative pain score - CHEOPS score(2, 4, 6, 24 hours after surgery)
- To compare diaphragmatic excursion.(At baseline and in immediate post-operative)
- To assess the time of first rescue analgesia administration.(Time when first rescue analgesia was given.)
Investigators
Amrita Chatterjee
Vardhman Mahavir Medical College and Safdarjung Hospital