NCT04095325

Brief Summary

Regional anesthesia and analgesia techniques are frequently used to provide pain control in pediatric surgical applications. The main advantages of these techniques include ease of application, good analgesic efficacy and low risk of complications (1). It reduces the need for parenteral opioids and increases the quality of postoperative pain control and the satisfaction of the patient and family (2). The aim of this study was to compare the contribution of TAP block and ESP block combined with sedation in pediatric surgery to anesthesia and analgesia during surgery without general anesthesia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 6, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

September 6, 2019

Last Update Submit

September 18, 2019

Conditions

Intraoperative Pain Control

Outcome Measures

Primary Outcomes (1)

  • Visual analogue scale

    effectiveness of erector spinae block on intraoperative anesthesia

    4 months

Study Arms (2)

transversus abdominis plane block

ACTIVE COMPARATOR

Group 1 (n: 50): those who underwent TAP block after induction of propofol atropine and maintained with only 1 mg / kg / h propofol in anesthesia maintenance

Device: Ultrasound guided erector spinae block

erector spinae block

ACTIVE COMPARATOR

Group 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance

Device: Ultrasound guided erector spinae block

Interventions

Ultrasound guided erector spinae blockDEVICE

Group 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance

erector spinae blocktransversus abdominis plane block

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • ASA I-II,
  • undergo elective lower abdominal surgery
  • years

You may not qualify if:

  • Psychiatric patients,
  • weight\> 40 kg,
  • those with cardiac-pulmonary-neurological disease,
  • those with bleeding disorders,
  • infection or wound scarring at the injection site,
  • known allergy to local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan University

Erzincan, 24100, Turkey (Türkiye)

Location

Related Publications (6)

  • Kot P, Rodriguez P, Granell M, Cano B, Rovira L, Morales J, Broseta A, Andres J. The erector spinae plane block: a narrative review. Korean J Anesthesiol. 2019 Jun;72(3):209-220. doi: 10.4097/kja.d.19.00012. Epub 2019 Mar 19.

    PMID: 30886130RESULT

  • Tanaka M, Mori N, Murakami W, Tanaka N, Oku K, Hiramatsu R, Nakagawa M, Yasumoto K. [The effect of transversus abdominis plane block for pediatric patients receiving bone graft to the alveolar cleft]. Masui. 2010 Sep;59(9):1185-9. Japanese.

    PMID: 20857679RESULT

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PMID: 27501016RESULT

  • Hernandez MA, Palazzi L, Lapalma J, Cravero J. Erector spinae plane block for inguinal hernia repair in preterm infants. Paediatr Anaesth. 2018 Mar;28(3):298-299. doi: 10.1111/pan.13325. Epub 2018 Jan 17.

    PMID: 29341379RESULT

  • Stuart-Smith K. Hemiarthroplasty performed under transversus abdominis plane block in a patient with severe cardiorespiratory disease. Anaesthesia. 2013 Apr;68(4):417-20. doi: 10.1111/anae.12108. Epub 2012 Dec 17.

    PMID: 23252578RESULT

  • Tekelioglu UY, Demirhan A, Sit M, Kurt AD, Bilgi M, Kocoglu H. Colostomy with Transversus Abdominis Plane Block. Turk J Anaesthesiol Reanim. 2015 Dec;43(6):424-6. doi: 10.5152/TJAR.2015.89410. Epub 2015 Dec 1.

    PMID: 27366540RESULT

Central Study Contacts

ilke küpeli

CONTACT

+905555485632ilkeser2004@gmail.com

ufuk kuyrukluyıldız

CONTACT

drufuk2001@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assist. prof.

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 19, 2019

Study Start

October 1, 2019

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)