Erector Spinae Plane Block in Pediatric Hip Surgery

Analgesia Clinical Trial

Official title:

Evaluation of Post Operative Analgesia of the Erector Spinae Plane Block in Pediatric Patients Undergoing Hip Surgery: a Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04354571
• Other study ID #: 1234
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2019
• Est. completion date: September 2020

Study information

• Verified date: April 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hip Surgery in pediatric patients is considered an extremely painful procedure. Managing pain in this surgery is challenging even with several available options, each with limitations. Erector spinae plane (ESP) block is a novel technique that has been used in different types of surgery, with promising results. Many case reports for use of ESPB are available in the literature but to our knowledge, no cohort studies or randomized controlled trials have been performed on ESPB for hip surgery in pediatrics age group against a traditional method as caudal block.1,2 AIM OF WORK

. The Primary outcome of this study is to compare the efficacy of analgesia resulting from the Erector spinae plane block versus the caudal block in pediatric patients undergoing hip surgery using the FLACC score and the duration of the analgesia of both methods till the first rescue analgesic.

The Secondary outcome is to compare the analgesic rescue frequency and total dose given in both groups as well as comparing the complications that might occur from each analgesic technique.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

Inclusion Criteria:

• ASA I II scheduled for hip surgery.

Exclusion Criteria:

• • Parent refusal

• Coagulopathy

• Patient with congenital heart disease

• Infection at the site of puncture

• Significant spinal anatomical anomaly

• Patient with neuromuscular disorder

• Any known allergy to the drug used

Related Conditions & MeSH terms

• Analgesia

Intervention

Procedure:
• Erector spinae plane block
An ultrasound-guided Erector spinae plane block was performed with the patient lying on the his side and the surgical side on the top. After skin disinfection, sterile draping was be placed and the ultrasound probe was sheathed. The level of the block was the transverse process of L2. The block was performed using a 9-12 MHz linear probe (LOGIQe, GE Healthcare, USA), which was placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) was identified, and a 22 G, 50 mm insulated needle (Sonoplex Stim, Pajunk, Germany) was inserted cranio-caudally in plane between the transverse process and the fascia of the ESM. After negative aspiration, 0.3 ml/kg of 0.25% bupivacaine was injected to confirm the correct position by visualizing the solution lifting the ESM off the transverse process.
• caudal block
caudal block was performed using anatomical landmarks and ultrasound guided and confirmed with a concentration of bupivacaine of 0.25%.

Locations

Country	Name	City	State
Egypt	Alexandria university	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment	Pain was assessed using face, legs, activity, and cry consolability scale [FLACC] 1-10 1 is no pain and 10 is the worst pain.	1 day .
Secondary	complications	not any complication related to the block	through study completion, an average of 1 day