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

NCT ID: NCT07069101

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-12-01

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.

Detailed Description

Rib fractures occur in up to 12% of all trauma patients, most commonly due to blunt thoracic trauma, and pose a significant health care burden with their associated morbidity and mortality.

The erector spinae plane block (ESB) is a myofascial plane technique in which a needle is inserted under ultrasound guidance deep to the erector spinae muscle group, allowing an infusion of local anesthetic to diffuse to both the dorsal and ventral rami of the spinal nerves, thereby supplying the rib cage. This technique can be used as a single-shot method or to facilitate the placement of a catheter, allowing for continuous infusion and/or intermittent bolus to provide long-lasting analgesia.

The edge of laminar block (ELB) is a novel technique in which local anesthetics are injected at the lateral edge of the lamina. It has been proven to provide sensory analgesia during rib fractures.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Erector spinae group

Patients will receive continuous ipsilateral erector spinae plane block.

Group Type: EXPERIMENTAL

Erector spinae block

Intervention Type: OTHER

Patients will receive continuous ipsilateral erector spinae plane block.

Edge of lamina group

Patients will receive continuous ipsilateral edge of laminar block.

Group Type: EXPERIMENTAL

Edge of lamina block

Intervention Type: OTHER

Patients will receive continuous ipsilateral edge of laminar block.

Interventions

Erector spinae block

Patients will receive continuous ipsilateral erector spinae plane block.

Intervention Type: OTHER

Edge of lamina block

Patients will receive continuous ipsilateral edge of laminar block.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Heba Abdel Hamid Muhammed

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Heba A Muhammed, Master

Role: CONTACT

heba.abdelhamid@med.tanta.edu.eg

00201032901343

Facility Contacts

Heba A Muhammed, Master

Role: primary

heba.abdelhamid@med.tanta.edu.eg

00201032901343

Other Identifiers

36265MD297/10/24

Identifier Type: -

Identifier Source: org_study_id