Ultrasound Guided Bilateral Retrolaminar Block as Analgesia for Adolescent Idiopathic Scoliosis Correction

NCT04336111 | Recruiting

• 1 other identifier: retrolaminar block
• Study Type: interventional
• Target: 44
• 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 retrolaminar block is a recently described ultrasound-guided technique in which local anesthetics is injected into the fascial plane between the posterior surface of the thoracic lamina and the overlying transverso-spinalis muscles. (2) The available evidence indicates that retrolaminar 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

Retrolaminar Block; Analgesia; Adolescent; Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• time to first analgesic request

  time to first analgesic request

  within 24 hrs postoperative

Secondary Outcomes (2)

• intraoperative fentanyl consumption

  intraoperative

• postoperative morphine consumption

  within 24 hrs postoperative

Study Arms (2)

control group

NO INTERVENTION

will receive sham bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10 after induction of anaesthesia in prone position.

retrolaminar block

EXPERIMENTAL

will receive real bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10 after induction of anaesthesia in prone position. The total desired volume used in the whole injection will be 40 ml containing 3mg / kg bupivacaine with adrenaline 2.5 2 µg/ml. The total 40 ml volume will be divided into 10 ml for each injection.

Procedure: retrolaminar block

Interventions

retrolaminar block PROCEDURE

will receive real bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10 after induction of anaesthesia in prone position. The total desired volume used in the whole injection will be 40 ml containing 3mg / kg bupivacaine with adrenaline 2.5 2 µg/ml. The total 40 ml volume will be divided into 10 ml for each injection.

retrolaminar 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

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: 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 30, 2023
• Primary Completion: March 31, 2024
• Study Completion: April 10, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

EG (1)