Continuous Erector Spinae Block Versus Continuous Edge of... | NCT07069101

Studies
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

Sponsor

Tanta University

Status

Recruiting

Last Update Posted

Jul 20, 2025Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

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

Interventions

Erector spinae block
Edge of lamina block

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2024Actual

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Jul 5, 2025

First Submission Date that Met QC Criteria

Jul 5, 2025

First Posted Date

Jul 16, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2025

Last Update Posted Date

Jul 20, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Heba Abdel Hamid Muhammed, Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Department, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Erector spinae block	Other	Patients will receive continuous ipsilateral erector spinae plane block.	Erector spinae group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Degree of pain	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.	4 days postoperatively
Diaphragmatic excursion

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Heba A Muhammed, Master	Contact	00201032901343		heba.abdelhamid@med.tanta.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University	Recruiting	Tanta	El-Gharbia	31527	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Types

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.

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms