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

Post Operative Pain Clinical Trial

Official title:

Comparison of Analgesic Efficacy of Sacral erectOR Spinae Plane Block and Caudal Block in Patients Undergoing Hypospadias Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05632536
• Other study ID #: 240819
• Status: Completed
• Phase: N/A
• Start date: December 21, 2022
• Est. completion date: December 19, 2023

Study information

• Verified date: December 2023
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of clinical trial is to compare in of analgesic efficacy of sacrale erector spinae plane block and caudal block in patients undergoing hypospadias surgery.We will include children between the ages of 6 months and 7 years in the 1st and 2nd categories in the ASA.

In our study, we seek answers to the following questions:

• Which of the sacral erector spinae plane block and caudal block applied to patients undergoing hypospadias surgery has higher postoperative analgesic efficiency than the other?

• Which of the sacral erector spinae plane block and caudal block applied to patients 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.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-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.

Description:

Our research will be conducted in a prospective randomized controlled in a single center. In our hospital December 2022-December 2023 aged 6 months to 7 years period will be applied to hypospadias surgery, ASA I-II pediatric patient in the group with 60 patients included in the study randomisation was planned to be made and to be sealed. Two groups will be formed in which sacral ESP and caudal block are applied so that there will be 30 patients in each. Patients will be randomized into 2 groups, using the sealed envelope technique based on computer-generated randomized numbers.

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.

The age, height, weight, gender and ASA (American Society of Anaesthesiology) scores of the patients in both groups will be recorded.

After the patients are taken to the operation table, standard monitoring will be performed. Patients's heart rate (HR), mean arterial pressure (OAB), body temperature, peripheral oxygen saturation (SpO2) will be monitored and anaesthesia before induction (basal value), before surgical incision, after surgical incision, before awakening, postoperative 5. - 30. min values will be recorded.

All patients will be placed in an IV cannula using 8% sevoflurane in 50/50 O2 / air for 2 - 4 minutes with a face mask, followed by induction of inhaled anesthesia. All patients will be placed in I-gel (supraglottic airway vehicle) by performing routine induction of general anesthesia with propofol 2-3 mg kg-1, fentanyl 1 mcg kg-1 and appropriate height for weight. Patients will be taken to artificial respiration support and tidal volume will be set to 8- 10 ml/kg and minute breathing will be set to 16-26. The end tidal carbon dioxide will be kept between 35-40 mmHg. Anesthesia maintenance will be provided with a starting dose of sevoflurane 2% and IV remifentanil 0.05 mcg kg-1 min-1 with a flow of 3 Lt min-1, an O₂/air mixture. >20% increase in intraoperative heart rate will be evaluated as pain and remifentanil dose will be increased and the need for remifentanil used intraoperatively will be recorded.

Group ESP (n=30) patients will be given a lateral decubitus position under general anesthesia before the operation and sacral ESP block will be performed accompanied by ultrasound. Group C (n=30) patients who will undergo caudal block will also be given a lateral decubitus position and ultrasound-guided block will be performed.

After block applications 15. min surgery will be initiated. All operations will be performed by the same experienced team with the same surgical technique.

Near the end of the operation, 15 mg kg-1 IV paracetamol will be given. At the end of the operation, the duration of operation will be recorded.

Patients after surgery 5. minutes and 30. minutes and 1. ,2. ,4. ,6. ,12. ,24. on the hours the pain scoring system Face, Legs, Activity, Cry, Consolability (FLACC) will be recorded.

At the end of the operation, the time until the time when there is a need for analgesia will be evaluated as "the first need for analgesia (hour)".

Total amount of additional analgesia (oral paracetamol, mg), amount of rescue analgesia (oral ibuprofen, mg), patient relative satisfaction (1-Not satisfied, 2-Satisfied, 3-Very satisfied) will be recorded.

Motor weakness, neurological deficit, urinary retention, nausea, vomiting, hypotension, bradycardia, itching, local anesthetic toxicity and bleeding that may occur in patients were planned to be recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 19, 2023
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 6 Months to 7 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiology (ASA) I-II group

• 6 months to 7 years old

• Paediatric age group patients who will undergo hypospadias surgery under general anesthesia

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypospadias
• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• SACRAL ESP AND CAUDAL BLOCK
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

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Research and Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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 ava — View Citation

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. — View Citation

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. — View Citation

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): — View Citation

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 2 — View Citation

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 Progres — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the analgesic effects of sacral ESP and caudal block with Face/ Leg/ Activity/ Cry/ Consolability (FLACC) scores in patients undergoing hypospadias surgery.	Evaluation of the analgesic effects of sacral ESP and caudal block with FLACC scores in patients undergoing hypospadias surgery. According to this scoring system, each category is between 0-2, The total score ranges from 0 to 10. 0 points that the game is calm and relaxed, between 1-3 score players are mildly disturbing, scores 4-6 games are moderate He had surgery, scores between 7-10 the player is noticeably disturbing, Pain or harm together reports that.	1 year