CTRI

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CTRI Number

CTRI/2026/02/102769 [Registered on: 02/02/2026] Trial Registered Prospectively

Last Modified On:

01/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison of two different nerve block techniques for reducing pain in children after keyhole chest surgery.

Scientific Title of Study

Comparison of Erector Spinae Plane Block and Serratus Anterior Plane Block for Post operative analgesia in Pediatric Throacoscopic surgeries

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Anjith V
Designation	Junior Resident (Academic)
Affiliation	All India Institute of Medical Sciences
Address	Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi South DELHI 110029 India
Phone	9787542172
Fax
Email	anjithvinod36@gmail.com

Details of Contact Person
Scientific Query

Name	Anju Gupta
Designation	Associate Professor
Affiliation	All India Institute of Medical Sciences
Address	Department of Anaesthesiology, Pain Medicine and Critical Care Room no 06, Porta cabin 4th floor Main Block All India Institute of Medical Sciences, New Delhi South DELHI 110029 India
Phone	9911573371
Fax
Email	dranjugupta09@gmail.com

Details of Contact Person
Public Query

Name	Anju Gupta
Designation	Associate Professor
Affiliation	All India Institute of Medical Sciences
Address	Department of Anaesthesiology, Pain Medicine and Critical Care Room no 06, Porta cabin 4th floor Main Block All India Institute of Medical Sciences, New Delhi South DELHI 110029 India
Phone	9911573371
Fax
Email	dranjugupta09@gmail.com

Source of Monetary or Material Support

All India Institute of Medical Sciences(AIIMS), New Delhi Ansari Nagar, New Delhi - 110029 Delhi, India

Primary Sponsor

Name	All Indian Institute of Medical Sciences
Address	AIIMS, Ansari Nagar, Delhi 110029
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Anjith V	All India Institute of Medical Sciences, New Delhi	Paediatric surgery OT, Mother and Child Hospital Block, AIIMS, New Delhi Ansari Nagar, New Delhi-110029 Delhi, India South DELHI	9787542172 anjithvinod36@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institute Ethics Committee, AIIMS, New Delhi	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: J958\|\|Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Erector Spinae plane block	The Erector Spinae Plane (ESP) block is an ultrasound-guided injection of local anesthetic deep to the erector spinae muscle, aiming to block spinal nerves for pain relief. Its considered a potentially safer and less complex regional anesthesia option for procedures like thoracoscopic surgeries. The intervention will take a total of 15 minutes and the observation period extends upto 24 hours after surgery
Comparator Agent	Serratus Anterior Plane Block	The Serratus Anterior Plane (SAP) block involves injecting local anesthetic near the serratus anterior muscle, often guided by ultrasound. This technique primarily targets the lateral cutaneous branches of the intercostal nerves, providing pain relief mainly to the anterolateral chest wall. The procedure will take 15 minutes while the observation will be for 24 hours post surgery

Inclusion Criteria

Age From	2.00 Month(s)
Age To	10.00 Year(s)
Gender	Both
Details	1.Children aged 2 months to 10 years 2. ASA Physical status I-III 3. Scheduled for thoracoscopic surgery

ExclusionCriteria

Details

1. Known allergy or hypersensitivity to local anesthetics such as ropivacaine
2. Coagulopathy or bleeding disorders, or if the patient is receiving anticoagulant therapy
3. Infection at the proposed injection site (e.g., local cellulitis or abscess)
4. Pre-existing neuromuscular disorders (e.g., muscular dystrophy, myasthenia gravis) or chronic pain conditions that may interfere with pain perception or assessment
5. Developmental delay or cognitive impairment that prevents reliable use of the FLACC pain scale
6. Refusal to participate by parent or legal guardian or withdrawal of consent at any point
7. Requirement for postoperative mechanical ventilation, either planned or anticipated intraoperatively
8. Conversion to thoracotomy.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Primary Outcome

Outcome	TimePoints
Comparison of postoperative pain intensity between the ESPB and SAPB groups, specifically measured using the FLACC score at the 3 hour mark post surgery.	at 3 hour mark after surgery

Secondary Outcome

Outcome	TimePoints
Compare the total intraoperative and postoperative fentanyl consumption between the Erector Spinae Plane Block (ESPB) group and the Serratus Anterior Plane Block (SAPB) group.	During surgery and till 24 hrs post surgery
Compare postoperative pain intensity using the FLACC (Face, Legs, Activity, Cry, Consolability) score at 1, 6, 12 and 24 hours postoperatively between the two groups.	At 1, 6, 12, 24 hours postoperatively
Compare the time interval from the end of surgery to the first administration of rescue analgesia between the two groups.	Until 24 hours postoperatively
Assess parental satisfaction with the allocated postoperative pain management regimen using a 5-point Likert scale.	During 24 hour postoperative period
Assess early functional recovery using caregiver-reported outcomes, potentially including parameters like mobility, feeding, and sleep patterns.(Boretsky recover Bingo card	During 24 hour postoperative period
Compare salivary cortisol levels, as a physiological marker of stress, at baseline, at one hour, and 24 hours postoperatively between the two groups.	Baseline, at one hour and 24 hours post surgery
Evaluate and compare the incidence of adverse events, including postoperative nausea and vomiting (PONV), sedation, hypotension, and any complications directly related to the nerve block procedure (e.g., hematoma, infection, visceral injury), between the two groups.	During surgery and till 24 hour post operative period

Target Sample Size

Total Sample Size="58"
Sample Size from India="58"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

12/02/2026

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This prospective, randomized, double-blinded controlled trial, titled Comparison of Erector Spinae Plane Block and Serratus Anterior Plane Block for Postoperative Analgesia in Pediatric Thoracoscopic Surgeries, A Randomized Trial, aims to evaluate optimal regional analgesic strategies for children undergoing thoracoscopic surgery at AIIMS, New Delhi. Recognizing that even minimally invasive procedures can cause significant postoperative pain, and considering the limitations of traditional blocks in pediatrics, this study compares two ultrasound-guided interfascial plane blocks, the Erector Spinae Plane Block and the Serratus Anterior Plane Block. The core objective is to assess their comparative analgesic efficacy and safety, hypothesizing that ESPB will demonstrate non-inferior analgesic efficacy to SAPB in this patient population.

Following Institutional Ethics Committee approval and informed parental consent, 58 pediatric patients, aged 2 months to 10 years, ASA I-III scheduled for elective thoracoscopic surgery will be randomized to receive either ESPB or SAPB. The ESPB group will receive an ultrasound-guided block at the T5 level with 0.5 mL/kg of 0.25% ropivacaine plus clonidine 1 mcg/kg, while the SAPB group will receive an ultrasound-guided block at the 5th rib midaxillary line with a similar local anesthetic solution. Both blocks are administered post-induction of standardized general anesthesia, with the patient, parents, outcome assessor, and postoperative care team blinded to the allocated intervention.

The primary endpoint is the comparison of postoperative pain intensity using the FLACC score at 3 hours post-surgery. Key secondary outcomes include total intraoperative and 24-hour postoperative fentanyl consumption, FLACC scores at multiple other time points, time to first rescue analgesia, parental satisfaction, early functional recovery, salivary cortisol levels as a stress biomarker, and the incidence of adverse events or block-related complications. The findings are anticipated to provide robust evidence to inform clinical decision-making for postoperative pain management in pediatric thoracoscopic surgery.