Erector Spinae Plane Block in Pediatric Hip Surgery

NCT04354571 | Unknown DMC

• 1 other identifier: 1234
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• complications

  through study completion, an average of 1 day

Study Arms (2)

GROUP (Erector spinae block):

EXPERIMENTAL

were given general anesthesia plus Erector spinae plane block

Procedure: Erector spinae plane block

GROUP (caudal block):

ACTIVE COMPARATOR

were given general anesthesia plus caudal block

Procedure: caudal block

Interventions

Erector spinae plane block PROCEDURE

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.

GROUP (Erector spinae block):

caudal block PROCEDURE

caudal block was performed using anatomical landmarks and ultrasound guided and confirmed with a concentration of bupivacaine of 0.25%.

GROUP (caudal block):

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ASA I II scheduled for hip surgery.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria university

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: closed envelope technique
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia Alexandria university

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 21, 2020
• Study Start: August 11, 2019
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)