Erector Spina Plane (ESP) Block in Pediatric Patients

NCT ID: NCT04875390

Last Updated: 2022-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-10

Study Completion Date

2022-07-18

Brief Summary

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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

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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.

Conditions

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Acute Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type OTHER

Erector spina plane block

Intervention Type OTHER

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

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.

Group Type OTHER

local infiltration

Intervention Type OTHER

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

Interventions

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Erector spina plane block

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

Intervention Type OTHER

local infiltration

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hülya Kaşıkara

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Sengül Özmert

Role: STUDY_DIRECTOR

Ankara City Hospital Bilkent

Feyza Sever

Role: STUDY_DIRECTOR

Ankara City Hospital Bilkent

Halil Kara

Role: STUDY_DIRECTOR

Yıldırım Beyazıt University Medical Pharmacology

Locations

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hülya KAŞIKARA

Çankaya, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31630465 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30851499 (View on PubMed)

Other Identifiers

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ESP

Identifier Type: -

Identifier Source: org_study_id

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