Erector Spina Plane (ESP) Block in Pediatric Patients

Not Applicable

Completed

• Conditions: Acute Postoperative Pain
• Interventions: Other: local infiltration; Other: Erector spina plane block

• Registration Number: NCT04875390
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Study Timeline

• Study First Submitted: 2021-05-01
• Study First Submitted QC: 2021-05-01
• Study First Posted: 2021-05-06
• Study Start: 2021-05-10
• Status Verified: 2022-07
• Primary Completion: 2022-07-05
• Study Completion: 2022-07-18
• Last Update Submitted: 2022-07-22
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group L	local infiltration	Intraoperative local infiltration (0.6 ml/kg of 0.25% bupivacaine will be given to the wound lips at the end of the surgery.
group E	Erector spina plane block	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.

Primary Outcome Measures

Name	Time	Method
the 6th hour pediatric pain scale, face ,legs , activity; cry;consolability (FLACC)	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 Outcome Measures

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

Trial Locations

Locations (1)

hülya KAŞIKARA; 🇹🇷 Çankaya, Ankara, Turkey