NCT04875390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

May 1, 2021

Last Update Submit

July 22, 2022

Conditions

Acute Postoperative Pain

Keywords

erector spina plane blockpediatric patient

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • paracetamol consumption

    24 hours

Study Arms (2)

group E

OTHER

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

group L

OTHER

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

Interventions

Erector spina plane blockOTHER

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

group E
local infiltrationOTHER

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

group L

Eligibility Criteria

Age1 Month - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

hülya KAŞIKARA

Çankaya, Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 31630465BACKGROUND

  • 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.

    PMID: 30851499BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Hülya Kaşıkara

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

  • Sengül Özmert

    Ankara City Hospital Bilkent

    STUDY DIRECTOR

  • Feyza Sever

    Ankara City Hospital Bilkent

    STUDY DIRECTOR

  • Halil Kara

    Yıldırım Beyazıt University Medical Pharmacology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2021

First Posted

May 6, 2021

Study Start

May 10, 2021

Primary Completion

July 5, 2022

Study Completion

July 18, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)