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Comparison of Two Different Analgesic Regional Block Techniques in Pediatric Patients Undergoing a Hernia Repair

Primary Purpose

Post Operative Pain, Inguinal Hernia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Caudal Block
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Operative Pain focused on measuring Caudal block, Erector spinae block, Pediatric postoperative analgesia, Inguinal hernia

Eligibility Criteria

1 Year - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Pediatric patient scheduled for unilateral elective inguinal hernia operation ASA status 1-2 Exclusion Criteria: Pediatric patient's parents refusal Contraindications to regional anesthesia Known allergy to local anesthetics, Bleeding diathesis, Severe kidney or liver disease Presence of infection at the needle entry site.

Sites / Locations

  • Abant İzzet Baysal Education and Training HospitalRecruiting
  • Bolu Abant İzzet Baysal Medical SchoolRecruiting
  • Bolu Abant İzzet Baysal University Faculty of MedicineRecruiting
  • Karabuk University Training and Research HospitalRecruiting
  • Karabuk University Karabuk Training and Research HospitalRecruiting
  • Karabuk University Training and Research HospitalRecruiting
  • Karabük University Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ESP Group

Caudal Group

Arm Description

Erector Spinae Plane Block Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks

Caudal Block Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks

Outcomes

Primary Outcome Measures

Analgesic consumption
Opioid consumption, need for rescue analgesic

Secondary Outcome Measures

The Face, Legs, Activity, Cry and Consolability (FLACC) scale for pediatric pain evaluation.
FLACC scale ( Face, legs, activity, cry and consolability scale) is an observational scale comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10.Pain severity will be assessed on the FLACC scale from 0 to 10. A score of zero will be considered no pain and a score of 10 will be considered the most severe pain.
Parental Satisfaction Assessment
Satisfaction level of parents after pediatric will be saved as a numerical scale from 1 to 10; 1 will represent the lowest possible satisfaction level and 10 the highest satisfaction level.

Full Information

First Posted
May 4, 2023
Last Updated
June 7, 2023
Sponsor
Abant Izzet Baysal University
Collaborators
Karabuk University, Basaksehir Cam & Sakura Şehir Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05896072
Brief Title
Comparison of Two Different Analgesic Regional Block Techniques in Pediatric Patients Undergoing a Hernia Repair
Official Title
Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Caudal Block on Postoperative Pain in Children Undergoing Unilateral Inguinal Hernia Operation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abant Izzet Baysal University
Collaborators
Karabuk University, Basaksehir Cam & Sakura Şehir Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Lower abdominal operations; especially inguinal hernia repairs are one of the most frequently performed operations in the daily practice of pediatric surgeries.Regional anesthesia techniques are frequently and effectively used methods in postoperative pain control. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae plane block and caudal block in pediatric unilateral inguinal hernia operations
Detailed Description
Patient mobilization and providing adequate analgesia are important components of perioperative care in the day case procedures.Providing adequate postoperative analgesia in the pediatric age group is also important in terms of future pain perception and the development of chronic pain in the next period. Regional anesthesia techniques are very effective and frequently used methods in pain control in children.While central blocks such as caudal epidural block, spinal block are frequently used in inguinal surgeries in children, they have been used in peripheral blocks and successful results have been obtained. Although central blocks are frequently used in the pediatric population, depending on the relevant surgical site, due to the difficulty of application and the capacity to create motor block, the peripheral blocks are among the alternative methods. Although ESP (Erector spinae plane) block is an interfascial plane block, anatomical studies support the idea that some of its clinical benefit may be due to its extension into the paravertebral and epidural space. Its use for pediatric abdominal surgeries has also been reported. Simple randomization will be used in randomization. With 5% margin of error, 80% Power, the standard effect size was determined as 0,72. Pediatric patients in the ASA I-II group, aged 1-8 years, who will undergo elective unilateral inguinal hernia operation under general anesthesia, will be sufficient to include n= 30 cases in each group.The investigators plan to conduct a prospective randomized controlled study for pediatric day case inguinal hernia surgeries. Oral midazolam (0.5 mg/kg) will be given to all children as premedication. After standard monitoring with pulse oximetry, electrocardiography and noninvasive blood pressure measurement in the operating room, anesthesia will be induced with air in 8% sevoflurane and 50% oxygen. Then, a 24-gauge intravenous (iv) cannula will be placed and 1 µg/kg fentanyl and 2-3 mg/kg propofol will be administered for anesthesia induction. The airway will be secured with the ProSeal laryngeal mask airway (Intravent-Orthofix, Maidenhead, UK). Anesthesia will be maintained with 50% nitrous oxide and 2% sevoflurane in oxygen. Additional opioid medication use during the operations will be recorded. At the end of the surgery, all patients will be given acetaminophen 10 mg/kg iv for postoperative analgesia. All blocks will be done after the airway is secured before the surgery begins. Patients will be placed in the side-lying position for ESP block. Following skin preparation with 10% povidone iodine, the ultrasound probe will be placed 1-2 cm lateral to the midline at the sacral level. L1 level will be determined by counting upwards from the sacrum. After identification of the erector spinae muscle (ESM) and the transverse process, a block needle will be inserted deep into the ESM in the cranio-caudal direction using an in-plane technique. Correct needle position will be confirmed by the application of 0.5-1 ml local anesthetic (LA). For block efficacy a pre-calculated dose (0.5 ml/kg) of 0.25% bupivacaine (maximum dose is limited to 20 ml) will be used. In the caudal group the patients will be placed in the side-lying position for the caudal block. The sacral cornues will be palpated and the block needle will be advanced at an angle of 45 degrees.After the needle hits the sacrum the angle will be reduced and retract few millimeters in the epidural space in the sacral canal. It will be checked that there is no blood and cerebrospinal fluid with negative aspiration. Bupivacaine will be administered at the same dose, at a dose of %0.25, 0.5 ml/kg (the maximum dose is limited to 20 ml). A pain nurse was scheduled to assess pain using the Face, Legs, Activity, Crying, and Consolability (FLACC) scores both in the postoperative recovery room and in the ward. FLACC scores will be recorded at 0, 1, 2, 4, 6, 12, and 24 hours postoperatively. Additional analgesia was planned according to the FLACC scores of the patients. If the FLACC score is between 2 and 4, acetaminophen 10 mg/kg iv was planned as additional analgesia in the ward, and tramadol 1 mg/kg iv was planned as an additional analgesic if the FLACC score was > 4. Patients can be discharged after 6 hours postoperatively. Parents will be informed about pain assessment and instructed to give 10 mg/kg oral acetaminophen if FLACC scores are between 2 and 4, and 7 mg/kg oral ibuprofen if FLACC scores are 4 or more. Analgesic requirements in the first 24 hours postoperatively, time to first analgesia, and parental satisfaction with analgesia provided will be recorded at postoperative follow-up visits by one of the anesthetists who are unfamiliar with the study groups. Parental satisfaction levels will be recorded as a numerical scale from 1 to 10; 1 will represent the lowest possible satisfaction level and 10 the highest satisfaction level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Inguinal Hernia
Keywords
Caudal block, Erector spinae block, Pediatric postoperative analgesia, Inguinal hernia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ESP Group
Arm Type
Experimental
Arm Description
Erector Spinae Plane Block Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks
Arm Title
Caudal Group
Arm Type
Active Comparator
Arm Description
Caudal Block Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
Application of ultrasound-guided erector spinae plane block for perioperative analgesia for elective inguinal hernia repair. Erector spinae plane block will be administered under general anesthesia before the surgery Drug: Bupivacaine (Block Drug) For block performances, 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc).
Intervention Type
Procedure
Intervention Name(s)
Caudal Block
Other Intervention Name(s)
Caudal Epidural Block
Intervention Description
Application of caudal block for perioperative analgesia for elective inguinal hernia repair. The caudal block will be administered under general anesthesia before the surgery. Drug: Bupivacaine (Block Drug) 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc) for block performances
Primary Outcome Measure Information:
Title
Analgesic consumption
Description
Opioid consumption, need for rescue analgesic
Time Frame
24 Hour
Secondary Outcome Measure Information:
Title
The Face, Legs, Activity, Cry and Consolability (FLACC) scale for pediatric pain evaluation.
Description
FLACC scale ( Face, legs, activity, cry and consolability scale) is an observational scale comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10.Pain severity will be assessed on the FLACC scale from 0 to 10. A score of zero will be considered no pain and a score of 10 will be considered the most severe pain.
Time Frame
24 Hour
Title
Parental Satisfaction Assessment
Description
Satisfaction level of parents after pediatric will be saved as a numerical scale from 1 to 10; 1 will represent the lowest possible satisfaction level and 10 the highest satisfaction level.
Time Frame
24 Hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pediatric patient scheduled for unilateral elective inguinal hernia operation ASA status 1-2 Exclusion Criteria: Pediatric patient's parents refusal Contraindications to regional anesthesia Known allergy to local anesthetics, Bleeding diathesis, Severe kidney or liver disease Presence of infection at the needle entry site.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kenan Kart, MD
Phone
+905337723300
Email
kenankart@karabuk.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Ilker Ital, MD
Phone
+905337723300
Email
ilkerital@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenan Kart, MD
Organizational Affiliation
Karabuk University Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kasım İlker İtal
Organizational Affiliation
Bolu Abant University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Duygu Taskin
Organizational Affiliation
Karabuk University Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Abant İzzet Baysal Education and Training Hospital
City
Bolu
State/Province
Merkez
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Bolu Abant İzzet Baysal Medical School
City
Bolu
ZIP/Postal Code
14030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilker Ital, MD
Phone
(0374) 253 46 56
Email
ilkerital@gmail.com
Facility Name
Bolu Abant İzzet Baysal University Faculty of Medicine
City
Bolu
ZIP/Postal Code
14030
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilker Ital, MD
Phone
+905337723300
Email
ilkerital@gmail.com
First Name & Middle Initial & Last Name & Degree
Tacettin Ayanoglu, MD
Phone
+905312331970
Ext
İtal
Email
ilkerital@gmail.com
First Name & Middle Initial & Last Name & Degree
Duygu Taskin, MD
First Name & Middle Initial & Last Name & Degree
Ilker Ital, MD
First Name & Middle Initial & Last Name & Degree
Muzaffer Gencer, MD
First Name & Middle Initial & Last Name & Degree
Kenan Kart, MD
Facility Name
Karabuk University Training and Research Hospital
City
Karabuk
ZIP/Postal Code
78100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenan Kart, MD
Phone
+90 5063849983
Email
kenankart@karabuk.edu.tr
First Name & Middle Initial & Last Name & Degree
Duygu Taskin, MD
Phone
+90 5386606553
Email
duygutaskin@karabuk.edu.tr
First Name & Middle Initial & Last Name & Degree
Ilker Ital, MD
First Name & Middle Initial & Last Name & Degree
Muzaffer Gencer, MD
First Name & Middle Initial & Last Name & Degree
Duygu Taskin
First Name & Middle Initial & Last Name & Degree
Kenan Kart
Facility Name
Karabuk University Karabuk Training and Research Hospital
City
Karabük
ZIP/Postal Code
78100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenan Kart, MD
Phone
+90 5063849983
Email
kenankart@karabuk.edu.tr
First Name & Middle Initial & Last Name & Degree
Duygu Taskin, MD
Phone
+90 5386606553
Email
duygutaskin@karabuk.edu.tr
First Name & Middle Initial & Last Name & Degree
Ilker Ital, MD
First Name & Middle Initial & Last Name & Degree
Muzaffer Gencer, MD
Facility Name
Karabuk University Training and Research Hospital
City
Karabük
ZIP/Postal Code
78100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenan Kart, MD
Phone
+90 5063849983
Email
kenankart@karabuk.edu.tr
First Name & Middle Initial & Last Name & Degree
Duygu Taskin, MD
Phone
+90 5386606553
Email
duygutaskin@karabuk.edu.tr
First Name & Middle Initial & Last Name & Degree
Ilker Ital, MD
First Name & Middle Initial & Last Name & Degree
Muzaffer Gencer, MD
First Name & Middle Initial & Last Name & Degree
Duygu Taskin, MD
First Name & Middle Initial & Last Name & Degree
Kenan Kart, MD
Facility Name
Karabük University Training and Research Hospital
City
Karabük
ZIP/Postal Code
78100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenan Kart, MD
Phone
+90 5063849983
Email
kenankart@karabuk.edu.tr
First Name & Middle Initial & Last Name & Degree
Duygu Taskin, MD
Phone
+90 5386606553
Email
duygutaskin@karabuk.edu.tr
First Name & Middle Initial & Last Name & Degree
Ilker Ital, MD
First Name & Middle Initial & Last Name & Degree
Muzaffer Gencer, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
background
PubMed Identifier
30851499
Citation
Aksu C, Sen MC, Akay MA, Baydemir C, Gurkan Y. Erector Spinae Plane Block vs Quadratus Lumborum Block for pediatric lower abdominal surgery: A double blinded, prospective, and randomized trial. J Clin Anesth. 2019 Nov;57:24-28. doi: 10.1016/j.jclinane.2019.03.006. Epub 2019 Mar 6.
Results Reference
result
PubMed Identifier
34988963
Citation
Cosarcan SK, Mahli A. [Comparison of intraoperative and postoperative analgesic properties of ilioinguinal/iliohypogastric and sacral epidural block in pediatric unilateral inguinal hernia operations]. Agri. 2022 Jan;34(1):38-46. doi: 10.14744/agri.2021.48254. Turkish.
Results Reference
result

Learn more about this trial

Comparison of Two Different Analgesic Regional Block Techniques in Pediatric Patients Undergoing a Hernia Repair

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