Comparison of Analgesic Efficacy of ESP Block and Caudal Block in Patients Undergoing Hypospadias Surgery

NCT05632536 | Completed

• 1 other identifier: 240819
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of clinical trial is to compare in of analgesic efficacy of sacrale erector spinae plane (ESP) block and caudal block in participants undergoing hypospadias surgery. Investigators will include children between the ages of 6 months and 7 years in the 1st and 2nd categories in the ASA. In this study, investigators seek answers to the following questions: Which of the sacral (ESP) block and caudal block applied to participants undergoing hypospadias surgery has higher postoperative analgesic efficiency than the other? Which of the sacral ESP block and caudal block applied to participants undergoing hypospadias surgery is superior in duration of analgesia? After general anesthesia is administered to the participants, one of the 2 blocks will be administered in a randomized manner and the relevant data will be recorded. This research will be conducted in a single center as a prospective randomized controlled study. It was planned to include 60 participnts from the ASA I-II pediatric participants aged between 6 months and 7 years, who will undergo hypospadias surgery between December 2022-December 2023, and randomization will be done by closed envelope method. Two groups with sacral ESP and caudal block will be formed, each with 30 participants.

Conditions

Post Operative Pain; Hypospadias

Keywords

sacral erector spinae plane block; caudal block; hypospadias; pediatric surgery

Outcome Measures

Primary Outcomes (1)

• Duration of the analgesia

  The duration that elapsed between block application and the patient\'s first analgesic requirement (if FLACC\>3) was evaluated and recorded as \'\'duration of analgesia (hours)\'\'

  1 year

Secondary Outcomes (2)

• Evaluation of the analgesic effects of sacral ESP and caudal block with Face/ Leg/ Activity/ Cry/ Consolability (FLACC) scores in patients undergoing hypospadias surgery.

  1 year

• Morphine consumption

  1 year

Study Arms (2)

GROUP ESP

ACTIVE COMPARATOR

Before the operation, under general anesthesia, group ESP (n=30) patients will be blocked with the sacral ESP block method. By giving the lateral decubitus position, the linear ultrasound probe will be placed in the sterilized area longitudinally on the midline of the sacrum. The erector spinae muscle and the sacral medial crest will be visualized. The 22 gauge, 50 mm needle will be advanced in the direction from cranial to caudal to reach the sacral crest. 0.25% bupivacaine from a dose of 1 mL kg-1 will be aspirated and injected every 2 mL under the erector spina muscle at the level of the median sacral crest at the level of the 4th sacral vertebra. (A test dose will be administered with 1 mL of saline.)

Procedure: SACRAL ESP AND CAUDAL BLOCK

GROUP C

SHAM COMPARATOR

Group C (n=30) patients to whom caudal block will be applied will be placed in the lateral decubitus position and the linear ultrasound probe will be placed longitudinally in the sterilized area on the midline of the sacrum. A 2.5 cm 22 gauge needle will be inserted over the back skin of the sacral hiatus (located distal to the sacrum and formed by the two sacral cornua on its lateral edges) at a 90° position. The sacrococcygeal ligament will be crossed, the needle will be oriented approximately 25° and advanced approximately 2 to 3 mm to reach the sacral canal. After entering the sacral hiatus and confirming the location with negative aspiration method, 1 mL kg-1 0.25% bupivacaine will be injected by aspiration every 2 mL (test dose will be administered with 1 mL saline).

Procedure: SACRAL ESP AND CAUDAL BLOCK

Interventions

SACRAL ESP AND CAUDAL BLOCK PROCEDURE

Application of ultrasound-guided sacral erector spinae plane (ESP) block or ultrasound-guided caudal block with 1mL/kg 0.25% bupivacaine (local anesthetic) to patients

GROUP C; GROUP ESP

Eligibility Criteria

• Age: 6 Months - 7 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiology (ASA) I-II group
• months to 7 years old
• Paediatric age group patients who will undergo hypospadias surgery under general anesthesia

You may not qualify if:

• ASA III - IV patient group
• Patients who were operated on urgently
• Patient relatives who did not give consent
• Presence of local anesthetic allergy
• Presence of infection in the area to be blocked
• Presence of coagulation disorder
• Severe organ failure
• Pre-existing neurological deficit
• Mental Retardation
• Anatomical Deformity

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Sisli Hamidiye Etfal Research and Training Hospital

Sarıyer, Istanbul, 34450, Turkey (Türkiye)

Location

Related Publications (6)

• Mostafa SF, Abdelghany MS, Abdelraheem TM, Abu Elyazed MM. Ultrasound-guided erector spinae plane block for postoperative analgesia in pediatric patients undergoing splenectomy: A prospective randomized controlled trial. Paediatr Anaesth. 2019 Dec;29(12):1201-1207. doi: 10.1111/pan.13758. Epub 2019 Nov 8.

  PMID: 31630465 RESULT

• Aksu C, Gurkan Y. Sacral Erector Spinae Plane Block with longitudinal midline approach: Could it be the new era for pediatric postoperative analgesia? J Clin Anesth. 2020 Feb;59:38-39. doi: 10.1016/j.jclinane.2019.06.007. Epub 2019 Jun 13. No abstract available.

  PMID: 31203111 RESULT

• Kundra P, Yuvaraj K, Agrawal K, Krishnappa S, Kumar LT. Surgical outcome in children undergoing hypospadias repair under caudal epidural vs penile block. Paediatr Anaesth. 2012 Jul;22(7):707-12. doi: 10.1111/j.1460-9592.2011.03702.x. Epub 2011 Sep 29.

  PMID: 21957982 RESULT

• Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20.

  PMID: 32507565 RESULT

• Kaya C, Dost B, Tulgar S. Sacral Erector Spinae Plane Block Provides Surgical Anesthesia in Ambulatory Anorectal Surgery: Two Case Reports. Cureus. 2021 Jan 9;13(1):e12598. doi: 10.7759/cureus.12598.

  PMID: 33585088 RESULT

• Topdagi Yilmaz EP, Oral Ahiskalioglu E, Ahiskalioglu A, Tulgar S, Aydin ME, Kumtepe Y. A Novel Multimodal Treatment Method and Pilot Feasibility Study for Vaginismus: Initial Experience With the Combination of Sacral Erector Spinae Plane Block and Progressive Dilatation. Cureus. 2020 Oct 8;12(10):e10846. doi: 10.7759/cureus.10846.

  PMID: 33178502 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Hypospadias

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sevgi KESİCİ

  Sisli Etfal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The study was planned to be performed as a double blind. User sacral ESP and caudal block will be administered by an anesthesiologist not responsible for the perioperative and postoperative management of the patients. A second anesthesiologist, who will be in charge of patient monitoring and data recording, will be unaware of the patients' group assignments. Additionally, parents, surgeons, and other personnel involved in the data collection process will be unaware of the group to which the child is assigned. Surgeons will not be present in the operating room while the anesthesiologist administers the block (sacral ESP block or caudal block). All patients will undergo aseptic skin preparation using Betadine. Since bandages will be applied to two points, the actual injection site will not be known.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Our research will be conducted in a single center as a prospective randomized controlled study. It was planned to include 60 patients from the ASA I-II pediatric patient group aged between 6 months and 7 years, who will undergo hypospadias surgery in our hospital between December 2022 and December 2023, and randomization will be done by closed envelope method. Two groups with sacral ESP and caudal block will be formed, each with 30 patients.

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 30, 2022
• Study Start: December 21, 2022
• Primary Completion: December 18, 2023
• Study Completion: December 19, 2023
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)