Continuous Erector Spinae Block Versus Continuous Edge of Laminar Block on The Quality of Analgesia and Diaphragmatic Excursion in Patients With Multiple Rib Fractures

NCT07069101 | Recruiting

• 1 other identifier: 36265MD297/10/24
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized clinical trial aims to compare the effect of continuous erector spinae plane block versus continuous edge of laminar block on the quality of analgesia and diaphragmatic excursion in patients with unilateral traumatic multiple rib fractures.

Conditions

Erector Spinae Block; Edge of Laminar Block; Analgesia; Diaphragmatic Excursion; Multiple Rib Fractures

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  If the Numeric Rating Scale (NRS) is 4 or more IV morphine 3mg will be given.

  4 days postoperatively

Secondary Outcomes (6)

• Degree of pain

  4 days postoperatively

• Diaphragmatic excursion

  4 days postoperatively

• Incidence of adverse events

  4 days postoperatively

• Forced vital capacity

  4 days postoperatively

• Forced expiratory volume 1

  4 days postoperatively

Study Arms (2)

Erector spinae group

EXPERIMENTAL

Patients will receive continuous ipsilateral erector spinae plane block.

Other: Erector spinae block

Edge of lamina group

EXPERIMENTAL

Patients will receive continuous ipsilateral edge of laminar block.

Other: Edge of lamina block

Interventions

Erector spinae block OTHER

Patients will receive continuous ipsilateral erector spinae plane block.

Erector spinae group

Edge of lamina block OTHER

Patients will receive continuous ipsilateral edge of laminar block.

Edge of lamina group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 21 and 65 years.
• Both sexes.
• With unilateral traumatic multiple fracture ribs (≥ 3), admitted to the surgical intensive care unit within the first day of trauma.

You may not qualify if:

• Patients' rejection.
• Body mass index ≥ 35 (kg/m2).
• Bleeding and Coagulation disorders.
• Known hypersensitivity to the study drugs.
• Vertebral deformity.
• Respiratory, cardiac, renal or hepatic dysfunction.
• Patients with major trauma involving extra-thoracic structures (e.g., head, spine, pelvis, and abdominal visceral injuries).
• Mental or cognitive dysfunction,
• History of chronic analgesic or drug abuse.
• Local infection at the site of the block.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, 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

Central Study Contacts

Heba A Muhammed, Master

CONTACT

00201032901343; heba.abdelhamid@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: July 16, 2025
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)