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OpenTrials
Completed

NCT Number: NCT04690894

Erector Spinae Muscle Block Versus Caudal Block by Sonar in Pediatrics Undergoing Lower Abdominal Surgery

this prospective randomized double blind controlled study was conducted on 60 child scheduled for lower abdominal surgery under general anesthesia. the patients were randomly allocated into 3 parallel groups.group (ESB) patients received ultrasound-guided erector spinae block in a dose of 0.4mg/ml of 0.25%bupivacaine between the 10th transverse process and erector spinae muscles.group(CB) patients received ultrasound-guided caudal block in a dose of 2.5mg/kg of 0.25%bupivacaine. group(CO) did,t received any block

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Minya, 61111, Egypt

About this study

on arrival of the patients to the operative theatre and after placement of the standard monitoring general inhalational anesthesia was induced by face mask with sevoflurane (4-8%) in oxygen after IV cannula was secured patients received 1mic/kg fentanyl and intubation was facilitated by 0.5mg/kg atracurium. isoflurane 1-2% with oxygen was used for maintenance of anesthesia. after stabilization of the patient's hemodynamics and before skin incision erector spinae block or caudal block was performed with the patient in lateral position. after the block patients were flipped back to their normal supine position, surgery took place 10 min after injection of local anesthetic. after termination of surgery reversal of the atracurium was done by giving neostigmine in a dose of 0.04mg/kg and atropine 0.02mg/kg and awake extubation was done

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pediatric patients aged 2-6 years scheduled for lower abdominal surgery under general anesthesia

Exclusion criteria

  • parent refusal
  • spinal and meningeal anomalies
  • mental retardation
  • blood disease
  • infection at site of injection
  • drug allergy

Treatment and study plan

erector spinae block - caudal block

Procedure

the child placed in lateral position identification of spinous process of 10th thoracic vertebral then the transducer was moved 2.5 cm laterally to visualize the transverse process and a total of 0.4mg/kg of 0.25%bupivacaine was adminstered

Primary outcomes

  1. number of patients need rescue analgesia

    Time frame: 24 hours

    total number of patients need addition of anagesia

Secondary outcomes

  1. First analgesic request

    Time frame: 24 hours

    First time that patient require analgesia

  2. Hemodynamic changes in the study period

    Time frame: 24 hours

    Changes in HR and blood pressure

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patient Undergoing Lower Abdominal Surgery

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 31, 2020
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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