search
Back to results

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

Primary Purpose

Post Operative Pain, Hypospadias

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
SACRAL ESP AND CAUDAL BLOCK
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring sacral erector spinae plane block, caudal block, hypospadias, pediatric surgery

Eligibility Criteria

6 Months - 7 Years (Child)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Sisli Hamidiye Etfal Research and Training HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

GROUP ESP

GROUP C

Arm Description

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.)

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 24, 2022
Last Updated
July 29, 2023
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05632536
Brief Title
Comparison of Analgesic Efficacy of ESP Block and Caudal Block in Patients Undergoing Hypospadias Surgery
Official Title
Comparison of Analgesic Efficacy of Sacral erectOR Spinae Plane Block and Caudal Block in Patients Undergoing Hypospadias Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2022 (Actual)
Primary Completion Date
August 18, 2023 (Anticipated)
Study Completion Date
September 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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 October 2022 and October 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.
Detailed 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. 2 Groups will be formed in which sacral ESP and caudal block are applied so that there will be 30 patients in each. The study was planned to be performed as a single blind. Accordingly; The application of ESP block and caudal block will be performed by an anesthesiologist who will take part in the perioperative and postoperative management of patients. Since the patient population is a pediatric group, we foresee that the doctor who will closely monitor the patients should have control over the procedure applied to the patient, the dose of local anesthetic applied to the patient, the block making process and the block making time. Parents and surgeons will be unaware of the group to which patients are assigned. Surgeons will not be in the operating room while the anesthesiologist is applying the block (sacral ESP block or caudal block). Spanx and tape will be placed in both block areas (ESP block and caudal block) in all patients. With these measures, it will be ensured that the actual injection site is not 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. >25% 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. The time required to make the block will be saved. 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 anesthesia and the duration of the operation will be recorded. 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 anesthesia and the duration of the 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 systemFace, 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 (watch)". Nausea, vomiting, bradycardia, hypotension, itching, local anesthetic toxicity and bleeding that may occur in patients were planned to be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Hypospadias
Keywords
sacral erector spinae plane block, caudal block, hypospadias, pediatric surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 October 2022 and October 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.
Masking
ParticipantCare Provider
Masking Description
The study was planned to be performed as a single blind. According to this; ESP block and caudal block application will be performed by an anesthesiologist who will take part in the perioperative and postoperative management of the patients. Since the patient population is a pediatric group, we foresee that the doctor who will follow the patients closely should have a good grasp of the procedure applied to the patient, the dose of local anesthetic applied to the patient, the blocking process and the duration of the block. Parents and surgeons will be unaware of the group to which patients are assigned. Surgeons will not be in the operating room while the anesthesiologist performs a block (sacral ESP block or caudal block). Sponge and tape will be placed in both block sites (ESP block and caudal block) in all patients. With these precautions, it will be ensured that the actual injection site is not known.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GROUP ESP
Arm Type
Active Comparator
Arm Description
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.)
Arm Title
GROUP C
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
SACRAL ESP AND CAUDAL BLOCK
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluation of the analgesic effects of sacral ESP and caudal block with Face/ Leg/ Activity/ Cry/ Consolability (FLACC) scores in patients undergoing hypospadias surgery.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sevgi Kesici
Phone
+905058256335
Email
sevgikesici_25@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sevgi KESİCİ
Organizational Affiliation
Sisli Etfal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sisli Hamidiye Etfal Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34798
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
nur betül sancak demirci
Phone
05425488384
Email
nbsancak@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31630465
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):1201-1207. doi: 10.1111/pan.13758. Epub 2019 Nov 8.
Results Reference
result
PubMed Identifier
31203111
Citation
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.
Results Reference
result
PubMed Identifier
21957982
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.
Results Reference
result
PubMed Identifier
32507565
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 2020 May 20.
Results Reference
result
PubMed Identifier
33585088
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.
Results Reference
result
PubMed Identifier
33178502
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 Progressive Dilatation. Cureus. 2020 Oct 8;12(10):e10846. doi: 10.7759/cureus.10846.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs