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

• ClinicalTrials.gov Identifier: NCT04690894
• Recruitment Status: Completed
• First Posted: December 31, 2020
• Last Update Posted: March 8, 2021
• Sponsor: Minia University
• Information provided by (Responsible Party): Shadwa Rabea Mohamed, Minia University

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	Not Applicable

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 (Clinical Trial)
• 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: July 15, 2019
• Actual Primary Completion Date: January 15, 2020
• Actual Study Completion Date: February 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

Outcome Measures

Primary Outcome Measures :

1. number of patients need rescue analgesia [ Time Frame: 24 hours ]
   total number of patients need addition of anagesia

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 6 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Egypt

Faculty of Medicine

Minya, Egypt, 61111

Sponsors and Collaborators

Minia University

Investigators

• Study Director: Ibrahim Talaat, MD; professor

More Information

• Responsible Party: Shadwa Rabea Mohamed, lecturer, Minia University
• ClinicalTrials.gov Identifier: NCT04690894
• Other Study ID Numbers: 266:7/2019
• First Posted: December 31, 2020
• Last Update Posted: March 8, 2021
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No