Ultrasound Guided Bilateral Erector Spinae Block as Analgesia for Adolescent Idiopathic Scoliosis Correction

NCT04336046 | Suspended

• 1 other identifier: bilateral erector spinae block
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Scoliosis is a structural, tridimensional deformity of the spine. Characterized by lateral curvature and rotation of the vertebrae with functional limitations and cosmetic problems, idiopathic scoliosis, which accounts for 75% to 80% of all scoliosis, is the most common of all types. (1, 2) Surgical treatment is an effective way to correct severe spine deformity when the deformity progressively worsens and cannot be positively corrected by brace treatment. Spinal correction surgery is one of the most invasive surgical procedures and usually results in moderate to severe levels of postoperative pain. (3) Severe pain may induce implant complications such as construct dislodgement, broken instrumentation, and implant loosening which requires additional revision procedures These conditions adversely affect postoperative outcomes.(4) In the past several years, pain has become an important indicator for evaluating indicators of outcome and quality of life after surgery. Effective analgesia after surgery could improve patients' prognosis.(5) The erector spinae block is a recently described ultrasound-guided technique in which local anesthetics is injected into a fascial plane between the tips of the thoracic transverse processes and the overlying erector spinae muscle (longissimus thoracis).(6) The available evidence indicates that erector spinae block is effective in reducing opioid requirements and improving the pain experience in a wide range of clinical settings. They are best employed as part of multimodal analgesia with other systemic analgesics

Conditions

Erector Spinae Block; Analgesia; Scoliosis Idiopathic

Outcome Measures

Primary Outcomes (1)

• postoperative morphine consumption

  postoperative morphine consumption

  within 24 hours postoperative

Secondary Outcomes (2)

• intraoperative fentanyl consumption

  intraoperative

• time to first analgesic request

  within 24 hours postoperative

Study Arms (2)

control group

SHAM COMPARATOR

will receive sham bilateral ultrasounded guided erector spinae block using 1 mg /kg normal saline in a total volume of 20 ml for each side after induction of anaesthesia in prone position after induction of anaesthesia in prone position.

Procedure: sham bilateral ultrasounded guided erector spinae block; Drug: normal saline

erector spinae block

EXPERIMENTAL

will receive real bilateral ultrasounded guided erector spinae block by bupivacaine at 1 mg /kg in a total volume of 20 ml for each side after induction of anaesthesia in prone position

Procedure: erector spinae block; Drug: Bupivacaine

Interventions

erector spinae block PROCEDURE

will receive real bilateral ultrasounded guided erector spinae block by bupivacaine at 1 mg /kg in a total volume of 20 ml for each side after induction of anaesthesia in prone position

erector spinae block

sham bilateral ultrasounded guided erector spinae block PROCEDURE

will receive sham bilateral ultrasounded guided erector spinae block using 1 mg /kg normal saline in a total volume of 20 ml for each side after induction of anaesthesia in prone position after induction of anaesthesia in prone position.

control group

normal saline DRUG

using 1 mg /kg normal saline

control group

Bupivacaine DRUG

bupivacaine

erector spinae block

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with idiopathic adolescent scoliosis undergoing surgical correction.

You may not qualify if:

• Bleeding disorders (coagulopathy).
• Mental dysfunction.
• History of allergy to local anesthetics.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

tarek Abdel Lattif

Tanta, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Saline Solution; Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: December 31, 2025
• Primary Completion: January 30, 2026
• Study Completion: February 27, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)