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

Sponsor

Minia University (Other)

Overall Status

Completed

CT.gov ID

NCT04690894

Collaborator

(none)

Enrollment

Location

Arms

7.1

Actual Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Analgesia	Procedure: erector spinae block - caudal block	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 15, 2019

Actual Primary Completion Date :

Jan 15, 2020

Actual Study Completion Date :

Feb 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Erector spinae group the child received ultrasound-guided erector spinae muscle block in a dose of 0.4mg/kg of 0.25%bupivacaine between the 10th transverse process and erector spinae muscle	Procedure: erector spinae block - caudal block 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
Active Comparator: caudal group child received ultrasound-guided caudal block in a dose of 2.5mg/kg of bupivacaine 0.25%	Procedure: erector spinae block - caudal block 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
No Intervention: control child didn't received any regional block

Arm

Intervention/Treatment

Active Comparator: Erector spinae group

the child received ultrasound-guided erector spinae muscle block in a dose of 0.4mg/kg of 0.25%bupivacaine between the 10th transverse process and erector spinae muscle

Procedure: erector spinae block - caudal block

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

Active Comparator: caudal group

child received ultrasound-guided caudal block in a dose of 2.5mg/kg of bupivacaine 0.25%

Procedure: erector spinae block - caudal block

No Intervention: control

child didn't received any regional block

Outcome Measures

Primary Outcome Measures

number of patients need rescue analgesia [24 hours]
total number of patients need addition of anagesia

Secondary Outcome Measures

First analgesic request [24 hours]
First time that patient require analgesia
Hemodynamic changes in the study period [24 hours]
Changes in HR and blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Minya		Egypt	61111

Sponsors and Collaborators

Minia University

Investigators

Study Director: Ibrahim Talaat, MD, professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shadwa Rabea Mohamed, lecturer, Minia University

ClinicalTrials.gov Identifier:

NCT04690894

Other Study ID Numbers:

266:7/2019

First Posted:

Dec 31, 2020

Last Update Posted:

Mar 8, 2021

Last Verified:

May 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 8, 2021