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

Not Applicable

Recruiting

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

• Registration Number: NCT07069101
• Lead Sponsor: Tanta University

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.

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-07
• Study First Submitted: 2025-07-05
• Study First Submitted QC: 2025-07-05
• Study First Posted: 2025-07-16
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-20
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total morphine consumption	4 days postoperatively	If the Numeric Rating Scale (NRS) is 4 or more IV morphine 3mg will be given.

Secondary Outcome Measures

Name	Time	Method
Degree of pain	4 days postoperatively	The degree of pain will be assessed using the Numeric Rating Scale (NRS) at rest and on coughing will be assessed before the block, at 60 minutes after the block, and then every 8 hours for 4 days.
Diaphragmatic excursion	4 days postoperatively	Diaphragmatic excursion will be assessed before the block, at 60 minutes after the block, and then every 8 hours for 4 days.
Incidence of adverse events	4 days postoperatively	Incidence of adverse events such as hematoma, local anesthetic systemic toxicity, respiratory complications, pneumothorax, nausea, and vomiting.
Forced vital capacity	4 days postoperatively	Forced vital capacity (FVC) will be assessed before the block, at 60 minutes after block, and then every 8 hours for 4 days.
Forced expiratory volume 1	4 days postoperatively	Forced expiratory volume 1 (FEV1) will be assessed before the block, at 60 minutes after block, and then every 8 hours for 4 days.
Forced expiratory volume 1 (FEV1)/Forced vital capacity (FVC)	4 days postoperatively	Forced expiratory volume 1 (FEV1)/Forced vital capacity (FVC) will be assessed before the block, at 60 minutes after block, and then every 8 hours for 4 days.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt