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Clinical Trials/NCT06088836
NCT06088836
Completed
Not Applicable

Impact of Ultrasound- Guided Continuous Retro Laminar Block Versus Continuous Erector Spinae Plane Block on Incentive Spirometry Volumes and Pain Scores in Multiple Rib Fractures

Tanta University1 site in 1 country60 target enrollmentOctober 18, 2023

Overview

Phase
Not Applicable
Intervention
Retrolaminar block group
Conditions
Retrolaminar Block
Sponsor
Tanta University
Enrollment
60
Locations
1
Primary Endpoint
Maximum inspired volume
Status
Completed
Last Updated
10 months ago

Overview

Brief Summary

The aim of this study is to compare the incentive spirometry volume and analgesic efficacy of ultrasound guided continuous Retrolaminar block and continuous Erector spinae plain block in patients with multiple rib fractures.

Detailed Description

Thoracic epidural analgesia (TEA) and thoracic paravertebral block (TPVB) are strongly recommended techniques for managing thoracic neuropathic pain However, they can be technically challenging to perform and are associated with up to 15% failure rate in Thoracic epidural analgesia (TEA)and potential risk of pneumothorax in thoracic paravertebral block (TPVB).Newer approaches have been the focus of many studies in recent years; these approaches include retrolaminar block and erector spinae plane block. Retrolaminar block (RLB) is a new thoracic truncal block for controlling somatic pain in both the thoracic and abdominal walls. The Erector Spinae plane block (ESPB) has been used successfully to manage severe neuropathic pain arising from ribs .The basis to use ESPB is its likely site of action which is the dorsal and ventral rami of the thoracic spinal nerves.

Registry
clinicaltrials.gov
Start Date
October 18, 2023
End Date
June 18, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hossam Ibrahim Elsayed Ibrahim

Assistant Lecturer of Anesthesia, Surgical ICU and Pain Medicine Master's degree of Anesthesia, Surgical ICU And Pain Medicine

Tanta University

Eligibility Criteria

Inclusion Criteria

  • Age from 18 to 65 years old.
  • Both sexes.
  • Patients with unilateral multiple traumatic rib fractures (≥ 3 ribs).

Exclusion Criteria

  • 1st ken refusal.
  • Patients with any contraindication for regional block as:
  • Bleeding disorders.
  • Infection at the injection site.
  • Patients with hemodynamic instability.
  • Patients with known hypersensitivity to the study drugs
  • Unconscious patients
  • Patients with significant trauma outside the chest wall e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries
  • Patients with significant lung contusions, pneumothorax, flail chest
  • Chronic opioid users.

Arms & Interventions

Group I (Retrolaminar block group)

Patients received ultrasound guided Retrolaminar block bolus dose of 20 ml 0.25% bupivacaine then continuous infusion at a rate of 0.1 mL/kg/hr. for 4 days

Intervention: Retrolaminar block group

Group II (Erector spinae plane block group)

Patients received ultrasound guided Erector spinae plane block bolus dose of 20 ml 0.25% bupivacaine then continuous infusion at a rate of 0.1 mL/kg/hr. for 4 days

Intervention: Erector spinae plane block group.

Outcomes

Primary Outcomes

Maximum inspired volume

Time Frame: 4 days after intervention.

Maximum inspired volume will be measure by incentive spirometry which indicate less pain. Inspiratory capacity (IC) measured by Incentive Spirometry before the block, 30 minutes, 60 minutes after the blocks and then every six hours for subsequent 4 days.

Secondary Outcomes

  • Respiratory rate(4 days after intervention.)
  • Intensive care length of stay.(28 days after intervention)
  • Adverse effects and complications.(4 days after intervention.)
  • Hospital length of stay.(28 days after intervention)
  • Daily and total rescue analgesics consumption.(24 hours after intervention.)
  • PaO2(4 days after intervention.)
  • pH(4 days after intervention.)
  • PaCo2(4 days after intervention.)
  • FiO2(4 days after intervention.)

Study Sites (1)

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