Erector Spinea Plane Block in Pediatric Hip Surgery

NCT04374396 | Completed

• 1 other identifier: 33779/4/20
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled double-blind study will be carried out to evaluate the effect of ultrasound-guided erector spinae plane block on the postoperative analgesia in children after hip surgeries, the total morphine consumption in the first postoperative day will be the primary outcome and the time to first request for rescue analgesia and postoperative pain score will be the secondary outcome. The study will be carried out on pediatric patients undergoing hip surgery where they will receive real or sham ultrasound guided erector spinae plane block before the onset of the surgery.

Conditions

Postoperative Pain; Opioid Use

Keywords

Erecto spinae plane; Hip surgery; Children; Pain; Morphine consumption

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption in the first postoperative day

  Calculation of the total dose of morphine consumed in the first day after surgery

  The first 24 hours after surgery

Secondary Outcomes (2)

• The time to first request for rescue analgesia

  The first 24 hours after surgery

• Postoperative pain score

  every 2 hours in the first 8 hours then every 4 hours till 24 hours

Study Arms (2)

Group 1

SHAM COMPARATOR

patients in this group will receive sham ipsilateral ultrasound-guided single shot erector spinae block at L2 after induction of anaesthesia and before the start of surgery without injection of local anesthetics

Radiation: Sham ultrasound-guided single shot erector spinae plane block (ESP B)

Group 2

EXPERIMENTAL

patients in this group will receive real ipsilateral ultrasound-guided single shot erector spinae block at L2 after induction of anaesthesia and before the start of surgery with injection of 0.3 ml/kg of 0.25% of plain bupivacaine.

Procedure: Real ultrasound-guided single shot erector spinae plane block (ESP B)

Interventions

Real ultrasound-guided single shot erector spinae plane block (ESP B) PROCEDURE

ESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM. After negative aspiration, 0.3 mL/kg- of bupivacaine 0.25% will be injected confirming correct position by visualizing the solution lifting the ESM off the transverse process .Spread of LA between the L1 and L4 transverse processes will be thereafter visually tracked with the transducer. In the control group, no local anesthetics will be injected.

Group 2

Sham ultrasound-guided single shot erector spinae plane block (ESP B) RADIATION

EESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM. No local anesthetics will be injected

Group 1

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 1-5 years old, of both sexes, American Society of Anesthesiologists (ASA) physical status class I-II and scheduled for surgical treatment of hip disorder under general anesthesia will be included in this study

You may not qualify if:

• Parental refusal.
• Preexisting spinal deformity or profound mental retardation.
• Obese Children
• Known or suspected allergy to local anesthetics.
• Known or suspected coagulopathy
• Major cardiac, renal, or hepatic disorders.
• Children undergoing combined or bilateral surgeries.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine

Tanta, Algharbia, 31511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sameh Ismaiel, M.D

  Lecturer of Anesthesia and Intensive Care, Tanta University

  STUDY DIRECTOR

• Mohamed Abdullah, M.D

  Assistant Professor of Anesthesia and Intensive Care, Tanta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sham ESP block will be administrated in the control group Measurements will be obtained by anesthetist not participating in the study and blinded to its group
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia - Tanta Faculty of Medicine

Model Details: Parallel Assignment Prospective study

Study Record Dates

• First Submitted: May 1, 2020
• First Posted: May 5, 2020
• Study Start: July 28, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 2, 2021
• Last Updated: February 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)