Post operative pain relief comparison in children undergoing hypospadias repair using caudal epidural block and ultrasound guided pudendal nerve block

Not yet recruiting

• Conditions: Medical and Surgical, (2) ICD-10 Condition: N488||Other specified disorders of penis,

• Registration Number: CTRI/2022/12/048187
• Lead Sponsor: Maulana Azad Medical College and Associated Hospital

Brief Summary

Regional anaesthetic techniques are frequently used with general anaesthesia to manage intra and post-operative pain, reduce parenteral opioid requirement, and facilitate pain control during paediatric procedures. One of the most often used regional anaesthesia techniques in children is caudal epidural block (CEB). However, single injection CEB has a short duration of action and anatomical variations, and abnormalities may make administration of CEB challenging. Recently, peripheral nerve blocks are increasingly being employed for peri-operative analgesia when appropriate, as they have less risk of side effects as combined with neuraxial procedures. Also, the availability of ultrasound machines has made this easier and safer. Pudendal nerve block (PNB) is a peripheral nerve block that is frequently used to provide efficient pain control after penile surgery. A few previous studies have shown that PNB is effective for providing prolonged post operative analgesia.1,2 PNB can be accomplished utilising a landmark technique with transcutaneous use of a peripheral nerve stimulator or by ultrasonographic guidance (USG).2 Naja ZM et al compared effectiveness of PNB with CEB and found that the percentage of patients who received analgesics during the first 24 hours after hypospadias surgery was significantly higher in the CEB (70%) compared with the nerve stimulator guided PNB group (20%, p < 0.0001) and analgesic consumption was also higher in the CEB group.1 We decided to compare USG guided PNB with CEB for post operative analgesia in children undergoing hypospadias surgery.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-12-12
• Study Start: 2022-12-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Physical status ASA I-II.
• Age of patient 2-12 years 3.
• Anticipated duration of surgery: 1-2 hour.

Exclusion Criteria

• H/O growth retardation or mental disorder affecting pain score assessment 2.
• Patient or parent refusal for the block 3.
• Patients with bleeding and coagulation disorder 4.
• Patients with vertebral column abnormalities or any neurological disorders 5.
• Infection at injection site.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of patients requiring analgesia during the first 24 hours after surgery	12 MONTH

Secondary Outcome Measures

Name	Time	Method
• Pain scores (Modified Objective Pain Score)	• Postoperative analgesic consumption

Trial Locations

Locations (1)

Maulana Azad Medical College; 🇮🇳 Delhi, DELHI, India

Maulana Azad Medical College

🇮🇳Delhi, DELHI, India

Dr Pratibha Lakra

Principal investigator

8810208971

lakrapratibha7@gmail.com