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Erector Spina Plane (ESP) Block in Pediatric Patients

Primary Purpose

Acute Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector spina plane block
local infiltration
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Postoperative Pain focused on measuring erector spina plane block, pediatric patient

Eligibility Criteria

1 Month - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 1 month and 2 years of age
  • ASA (American Society of Anesthesiologists) I-II class
  • Patients who underwent nephrectomy, pyeloplasty, adrenal tumor excision with unilateral paramedian incision

Exclusion Criteria:

  • Patients who underwent laparotomy with a midline incision
  • Local infection at the injection site,
  • Anatomical anomalies
  • Allergies to local anesthetics,
  • Coagulopathy,
  • Liver, kidney failure patients

Sites / Locations

  • hülya KAŞIKARA

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

group E

group L

Arm Description

Intraoperative Erector spina plane block ( 0.3 ml/kg bupivacaine 0.25% at thoracic level 7 and 0.3 ml/kg bupivacaine 0.25% bupivacaine at thoracic level 11, totaling 0.6 ml/kg of 0.25% bupivacaine) will be performed after the surgery is completed.

Intraoperative local infiltration (0.6 ml/kg of 0.25% bupivacaine will be given to the wound lips at the end of the surgery.

Outcomes

Primary Outcome Measures

the 6th hour pediatric pain scale, face ,legs , activity; cry;consolability (FLACC)
FLACC : Each of the five categories (F)face; (L)legs; (A)activity; (C)cry; (C)consolability is scored from 0-2 which results in a total score between 0 and 10. 0:relaxed and comfortable, 1-3: mild discomfortable, 4-6: moderate pain, 7-10: severe pain

Secondary Outcome Measures

paracetamol consumption
the total number of paracetamol requirements in the first 24 hours in all patients

Full Information

First Posted
May 1, 2021
Last Updated
July 22, 2022
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT04875390
Brief Title
Erector Spina Plane (ESP) Block in Pediatric Patients
Official Title
Evaluation of the Effect of Ultrasonographic Guided Erector Spina Plan Block Application on Postoperative Analgesia in Infants Undergoing Laparotomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
July 5, 2022 (Actual)
Study Completion Date
July 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

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

5. Study Description

Brief Summary
In this study, we aimed to evaluate the erector spina plane (ESP) block method that we used in our clinic with ultrasonography in pediatric cases between 1 month and 2 years of age who underwent laparotomy.
Detailed Description
36 patients who will undergo laparotomy between the ages of 1 month and 2 years in ASA ( American Society of Anesthesiologists) I-II class will be included in the study. patients will be divided into 2 groups. Intraoperative erector spina plane block will be applied to the 1st group (group E) and intraoperative local anesthetic infiltration will be applied to the 2nd group (group L). Postoperative pain will be evaluated with the FLACC (face, legs, activity, crying, consolation) scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Postoperative Pain
Keywords
erector spina plane block, pediatric patient

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group E
Arm Type
Other
Arm Description
Intraoperative Erector spina plane block ( 0.3 ml/kg bupivacaine 0.25% at thoracic level 7 and 0.3 ml/kg bupivacaine 0.25% bupivacaine at thoracic level 11, totaling 0.6 ml/kg of 0.25% bupivacaine) will be performed after the surgery is completed.
Arm Title
group L
Arm Type
Other
Arm Description
Intraoperative local infiltration (0.6 ml/kg of 0.25% bupivacaine will be given to the wound lips at the end of the surgery.
Intervention Type
Other
Intervention Name(s)
Erector spina plane block
Intervention Description
After the surgery is completed, intraoperative Erector spina plane block will be performed
Intervention Type
Other
Intervention Name(s)
local infiltration
Intervention Description
After the surgery is completed, intraoperative local infiltration will be performed
Primary Outcome Measure Information:
Title
the 6th hour pediatric pain scale, face ,legs , activity; cry;consolability (FLACC)
Description
FLACC : Each of the five categories (F)face; (L)legs; (A)activity; (C)cry; (C)consolability is scored from 0-2 which results in a total score between 0 and 10. 0:relaxed and comfortable, 1-3: mild discomfortable, 4-6: moderate pain, 7-10: severe pain
Time Frame
6th hour
Secondary Outcome Measure Information:
Title
paracetamol consumption
Description
the total number of paracetamol requirements in the first 24 hours in all patients
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1 month and 2 years of age ASA (American Society of Anesthesiologists) I-II class Patients who underwent nephrectomy, pyeloplasty, adrenal tumor excision with unilateral paramedian incision Exclusion Criteria: Patients who underwent laparotomy with a midline incision Local infection at the injection site, Anatomical anomalies Allergies to local anesthetics, Coagulopathy, Liver, kidney failure patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hülya Kaşıkara
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sengül Özmert
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Feyza Sever
Organizational Affiliation
Ankara City Hospital Bilkent
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Halil Kara
Organizational Affiliation
Yıldırım Beyazıt University Medical Pharmacology
Official's Role
Study Director
Facility Information:
Facility Name
hülya KAŞIKARA
City
Çankaya
State/Province
Ankara
ZIP/Postal Code
06000
Country
Turkey

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
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
background

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Erector Spina Plane (ESP) Block in Pediatric Patients

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