Erector Spina Plane (ESP) Block in Pediatric Patients

Acute Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04875390
• Other study ID #: ESP
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: July 18, 2022

Study information

• Verified date: July 2022
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 18, 2022
• Est. primary completion date: July 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Postoperative Pain
• Pain, Postoperative

Intervention

Other:
• Erector spina plane block
After the surgery is completed, intraoperative Erector spina plane block will be performed
• local infiltration
After the surgery is completed, intraoperative local infiltration will be performed

Locations

Country	Name	City	State
Turkey	hülya KASIKARA	Çankaya	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Aksu C, Sen MC, Akay MA, Baydemir C, Gürkan 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6th hour
Secondary	paracetamol consumption	the total number of paracetamol requirements in the first 24 hours in all patients	24 hours