Erector Spina Plane (ESP) Block in Pediatric Patients

July 22, 2022 updated by: Ankara City Hospital Bilkent

Evaluation of the Effect of Ultrasonographic Guided Erector Spina Plan Block Application on Postoperative Analgesia in Infants Undergoing Laparotomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Çankaya, Ankara, Turkey, 06000
        • hülya KAŞIKARA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: group E
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.
Other: Erector spina plane block
After the surgery is completed, intraoperative Erector spina plane block will be performed
Other: group L
Intraoperative local infiltration (0.6 ml/kg of 0.25% bupivacaine will be given to the wound lips at the end of the surgery.
Other: local infiltration
After the surgery is completed, intraoperative local infiltration will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the 6th hour pediatric pain scale, face ,legs , activity; cry;consolability (FLACC)
Time Frame: 6th hour
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
6th hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
paracetamol consumption
Time Frame: 24 hours
the total number of paracetamol requirements in the first 24 hours in all patients
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Study Director: Feyza Sever, Ankara City Hospital Bilkent
  • Study Director: Sengül Özmert, Ankara City Hospital Bilkent
  • Principal Investigator: Hülya Kaşıkara, Ankara City Hospital Bilkent
  • Study Director: Halil Kara, Yıldırım Beyazıt University Medical Pharmacology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Actual)

July 5, 2022

Study Completion (Actual)

July 18, 2022

Study Registration Dates

First Submitted

May 1, 2021

First Submitted That Met QC Criteria

May 1, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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