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Completed

NCT Number: NCT04875390

Erector Spina Plane (ESP) Block in Pediatric Patients

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.

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Key information

Conditions

Acute Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

hülya KAŞIKARA

Çankaya, Ankara, 06000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector spina plane block

Other

After the surgery is completed, intraoperative Erector spina plane block will be performed

Local infiltration

Other

After the surgery is completed, intraoperative local infiltration will be performed

Primary outcomes

  1. 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

Secondary outcomes

  1. paracetamol consumption

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2021
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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