Comparison between spinal anaesthesia and caudal anaesthesia in children undergoing surgeries below umbilicus

Phase 4

Recruiting

• Conditions: Medical and Surgical, (2) ICD-10 Condition: Q552||Other and unspecified congenital malformations of testis and scrotum,

• Registration Number: CTRI/2023/07/054748
• Lead Sponsor: Dr. Keerthana S

Brief Summary

The present study is a Prospective, Randomized and Comparative study done after approval of Institutional Ethics Committee in pediatric patients satisfying all inclusion and exclusion Criteria planned for infraumbilical surgeries. Material used were Quincke type spinal needle of appropriate gauge, Sterile 2 cc and 5 ce syringes. Bupivacaine 0.5% Heavy ampoule, Bupivacaine 0.5% vial, Emergency drugs, IV Fluids, Anaesthesia workstation, suction apparatus Laryngoscope and ET Tubes of various sizes. After careful preoperative assessment of all patients’ standard monitors including NIBP, ECG, and pulse oximeter will be attached to the patient.



The study population is divided into two groups of 18 each. Group S undergoing Spinal block and Group C undergoing Caudal block. Group S patients receives spinal anaesthesia via midline approach with patients in lateral position under aseptic precautions. After getting free flow of CSF hyperbaric bupivacaine (0.5%) in a dose of 0.5 mg/kg will be injected in the subarachnoid space. Group C patients I will be given caudal block with full aseptic precautions in left lateral position. Drug-0.5% plain bupivacaine 2mg/kg (1ml/kg according to modified Armitage formula) will be given.



The level of sensory blockade, Heart rate and MAP will be recorded preoperatively and at 5 minutes intervals intraoperatively, and after completion of the surgery. Surgical pain is evaluated through children and infant postoperative pain scale (CHIPPS).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-14
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• American society of Anesthesiologist grade I 2.
• Pediatric cases scheduled for infraumbilical surgeries under spinal or caudal anaesthesia 3.
• Ages 2 to 10 years.

Exclusion Criteria

• Parent refusal 2.
• Infection at the site of injection 3.
• Coagulopathy 4.
• Increased intra-cranial pressure 5.
• Allergy to local anesthetics 6.
• Spinal deformities such as spina bifida and myelomeningocele 7.
• Sever aortic and mitral stenosis 8.
• Shock (haemorrhagic, septic).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the proportion of paediatric patients undergoing infraumbilical surgery in the Caudal & spinal anaesthesia groups who will achieve sensory blockade up to T6 level.	Till 60 mins post operatively

Secondary Outcome Measures

Name	Time	Method
1. To compare Hemodynamics in both the techniques	2. To compare post-operative analgesia in both the techniques

Trial Locations

Locations (1)

Dr Suheela Tiwari Hospital; 🇮🇳 Nainital, UTTARANCHAL, India

Dr Suheela Tiwari Hospital

🇮🇳Nainital, UTTARANCHAL, India

Keerthana S

Principal investigator

8722686989

keerthanareddy96.kr@gmail.com