"Comparison of USG-Guided Caudal Versus Ilioinguinal/Iliohypogastric Nerve Block for Pediatric Inguinal Surgeries"

NCT05558748 | Unknown DMC

• 1 other identifier: MREC#2919
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare the analgesic effectiveness of caudal analgesia to ilioinguinal regional analgesia techniques in children undergoing inguinal surgeries. Both techniques will be done under ultrasound gaudiness, using the same local anesthesia. 128 patients will be included in this study, 64 for each technique. This study aims to know the best regional analgesia technique in children undergoing inguinal surgeries, reduction in rescue analgesia postoperatively, postoperative length of stay, and early resumption of postoperative activity. The patients will be followed up 30 minutes after the end of anesthesia in PACU, postoperatively in Ward at 2 Hours, 3 hours, 6 hours from the end of anesthesia, and or at the time of discharge from the ward \& on days 2 and 7. Patient privacy and safety will be respected at all times. An interim analysis will be done after recruiting 25% of cases (16 cases) in both arms. Once the sample size is reached, the data will be sent for statistical analysis with coded patient identity. Based on study findings, the practice will be optimized with the aim of improvement in pain relief, reduction in opioid requirements, and enhanced recovery after surgery (ERAS), reducing the bed occupancy time in the hospital.

Conditions

Analgesia; Inguinal Surgery; Undescended Testes; Hydrocele; Torsion Testis; Varicocele; Ilioinguinal Nerve Block

Keywords

inguinal surgery; caudal anesthesia; nerve block; inguinal hernia; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Degree of pain relief

  Degree of analgesia will be checked postoperatively at 30 minutes after anesthesia in PACU, postoperatively in ward at 2, 3 and 6 hours from end of anesthesia and or at time of discharge from ward whichever is earlier.

  upto 1-2 days

Secondary Outcomes (1)

• Change in use of rescue analgesia postoperatively

  upto 1-2 days

Other Outcomes (1)

• Postoperative length of stay

  upto 1-2 days

Study Arms (2)

Pediatric patients undergoing inguinal surgeries with USG-guided Caudal block.

ACTIVE COMPARATOR

All pediatric patients (6 months to 12 year) posted for inguinal surgery under general anesthesia with USG-guided Caudal block for analgesia

Procedure: USG-guided Caudal block

Pediatric patients undergoing inguinal surgeries with USG-guided Ilioinguinal/Iliohypogastric block.

ACTIVE COMPARATOR

All pediatric patients (6 months to 12 year) posted for inguinal surgery under general anesthesia with USG-guided Ilioinguinal/Iliohypogastric block for analgesia

Procedure: USG-guided Ilioinguinal/Iliohypogastric block

Interventions

USG-guided Caudal block PROCEDURE

USG-guided Caudal block after general anesthesia

Pediatric patients undergoing inguinal surgeries with USG-guided Caudal block.

USG-guided Ilioinguinal/Iliohypogastric block PROCEDURE

USG-guided Ilioinguinal/Iliohypogastric block after general anesthesia

Pediatric patients undergoing inguinal surgeries with USG-guided Ilioinguinal/Iliohypogastric block.

Eligibility Criteria

• Age: 6 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 6 months to 12 years
• ASA I and II
• Type of surgery (Inguinal surgeries)

You may not qualify if:

• Refusal of consent
• ASA III and higher risk group
• Hemodynamically unstable
• Local infection over the insertion site
• Coagulopathy
• Known allergy to Local Anaesthetic medications
• Difficult anatomy

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, 123, Oman

RECRUITING

Related Publications (6)

• Finley AG, McGrath PJ, Forward PS, McNeill G, Fitzgerald P. Parents' management of children's pain following 'minor' surgery. Pain. 1996 Jan;64(1):83-87. doi: 10.1016/0304-3959(95)00091-7.

  PMID: 8867249 BACKGROUND

• Rawal N, Sjostrand U, Christoffersson E, Dahlstrom B, Arvill A, Rydman H. Comparison of intramuscular and epidural morphine for postoperative analgesia in the grossly obese: influence on postoperative ambulation and pulmonary function. Anesth Analg. 1984 Jun;63(6):583-92.

  PMID: 6233917 BACKGROUND

• Dalens B, Hasnaoui A. Caudal anesthesia in pediatric surgery: success rate and adverse effects in 750 consecutive patients. Anesth Analg. 1989 Feb;68(2):83-9.

  PMID: 2913854 BACKGROUND

• Disma N, Tuo P, Pellegrino S, Astuto M. Three concentrations of levobupivacaine for ilioinguinal/iliohypogastric nerve block in ambulatory pediatric surgery. J Clin Anesth. 2009 Sep;21(6):389-93. doi: 10.1016/j.jclinane.2008.10.012.

  PMID: 19833270 BACKGROUND

• Dawes JM, Cooke EM, Hannam JA, Brand KA, Winton P, Jimenez-Mendez R, Aleksa K, Lauder GR, Carleton BC, Koren G, Rieder MJ, Anderson BJ, Montgomery CJ. Oral morphine dosing predictions based on single dose in healthy children undergoing surgery. Paediatr Anaesth. 2017 Jan;27(1):28-36. doi: 10.1111/pan.13020. Epub 2016 Oct 25.

  PMID: 27779356 BACKGROUND

• Dua A, Afzal M. Caudal Anesthesia. 2025 Feb 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551693/

  PMID: 31869157 BACKGROUND

Related Links

• Nysora website
• ilioinguinal block complications
• Nysora: local anesthetic systemic toxicity
• ilioinguinaliliohypogastric-block
• Dosing-guidelines-for-pediatric-procedural-sedation-and-analgesia
• Role-of-fentanyl-in-pediatric-sedation

MeSH Terms

Conditions

Agnosia; Cryptorchidism; Testicular Hydrocele; Spermatic Cord Torsion; Varicocele; Hernia, Inguinal; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urogenital Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Postoperative Complications; Pathologic Processes; Pain

Study Officials

• Jyoti Burad, MD, EDIC

  Sultan Qaboos University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jyoti Burad, MD, EDIC

CONTACT

+96899578636; jyotiburad@yahoo.com

Amitabh Sen, M.D

CONTACT

+96894217105; amitabh@squ.edu.om

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant (patient) and the outcome assessor will be masked. Whereas the investigator who performs the block will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be randomized using a computer-generated sequence to one of the two intervention groups: USG-guided Caudal block and USG-guided Ilioinguinal/Iliohypogastric block. There will be no crossover.

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: September 28, 2022
• Study Start: December 6, 2022
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 12, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the Publication of the study, the data will be available on Mendeley for a few years
• Access Criteria: Any researcher requesting the data for further research will be given access.

Locations

OM (1)