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A clinical study to compare the pain relief after surgery between ultrasound guided transversus abdominis plane block & erector spinae plane block (two types of peripheral nerve blocks) in children undergoing abdominal surgery

A Randomised Controlled Trial To Compare Postoperative Analgesia Between Ultrasound Guided Transversus Abdominis Plane Block And Erector Spinae Plane Block In Children Undergoing Abdominal Surgery - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054121
Enrollment
80
Registered
2023-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K94- Complications of artificial openings of the digestive system Health Condition 2: K20-K31- Diseases of esophagus, stomach and duodenum Health Condition 3: K67- Disorders of peritoneum in infectious diseases classified elsewhere Health Condition 4: K91- Intraoperative and postproceduralcomplications and disorders of digestive system, not elsewhere classified Health Condition 5: K45- Other abdominal hernia Health Condition 6: K63- Other diseases of intestine Health Conditio

Interventions

Intervention1: To compare the duration of postoperative analgesia between ultrasound guided transversus abdominis plane block and erector spinae plane block in children aged 1-7 years undergoing abdom
Group E will receive 0.5mL/Kg of 0.25% levobupivacaine with clonidine at 1μg/Kg in USG guided erector spinae plane block on each side after induction of general anaesthesia. The patient would subsequ

Sponsors

Lady Hardinge Medical College and associated hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children belonging to the age group 1-7 years with ASA I & II physical status, scheduled for abdominal surgery

Exclusion criteria

Exclusion criteria: 1.History of any relevant drug allergy or chronic pain; 2.Any contraindication to the regional block such as coagulation disorder, needle infection at insertion site; 3.Duration of surgery > 3 hours; 4.Children undergoing laparoscopic procedures.

Design outcomes

Primary

MeasureTime frame
Mean duration of postoperative analgesia (in hours) in children aged 1-7 years undergoing abdominal surgery,Timepoint: Mean duration of postoperative analgesia (in hours) in children aged 1-7 years undergoing abdominal surgery.

Secondary

MeasureTime frame
Mean (±SD) requirement of analgesics (inj. fentanyl in μg)Timepoint: 24 hours postoperatively ;Median (IQR) parental satisfaction score (Likert scale)Timepoint: 24 hours postoperatively;Median (IQR) University of Michigan Sedation Score (UMSS)Timepoint: at 30 minute, 1 hour, 3 hours, 6 hours, 12 hours, & 24 hours in the postoperative period;Median [Interquartile range (IQR)] Childrenâ??s Hospital Eastern Ontario Pain Scale (CHEOPS) scoreTimepoint: at 30 minute, 1 hour, 3 hours, 6 hours, 12 hours, & 24 hours in the postoperative period;Proportion of patients developing side effects of the drugs i.e., clonidine (sedation, hypotension, bradycardia or dry mouth)Timepoint: 24 hours postoperatively

Countries

India

Contacts

Public ContactDr Jatin

Lady Hardinge Medical College and associated hospitals

ranjusingh1503@gmail.com9811151285

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026