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Clinical Trials/NCT07069101
NCT07069101RecruitingNot Applicable

The Effect of Continuous Erector Spinae Block Versus Continuous Edge of Laminar Block on The Quality of Analgesia and Diaphragmatic Excursion in Patients With Multiple Rib Fractures. A Prospective Randomized Trail.

Tanta University1 site in 1 country70 target enrollmentStarted: November 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
70
Locations
1
Primary Endpoint
Total morphine consumption

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Erector spinae group

Experimental

Patients will receive continuous ipsilateral erector spinae plane block.

Intervention: Erector spinae block (Other)

Edge of lamina group

Experimental

Patients will receive continuous ipsilateral edge of laminar block.

Intervention: Edge of lamina block (Other)

Outcomes

Primary Outcomes

Total morphine consumption

Time Frame: 4 days postoperatively

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

Secondary Outcomes

  • 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)
  • Forced expiratory volume 1 (FEV1)/Forced vital capacity (FVC)(4 days postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Heba Abdel Hamid Muhammed

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

Tanta University

Study Sites (1)

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