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Ultrasound- Guided Continuous Retro Laminar Block Versus Continuous Erector Spinae Plane Block in Multiple Rib Fractures

Primary Purpose

Retrolaminar Block, Erector Spinae Plane Block, Spirometry

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Retrolaminar block group
Erector spinae plane block group.
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retrolaminar Block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Uncooperative patients and patients with psychiatric illness

Sites / Locations

  • Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I (Retrolaminar block group)

Group II (Erector spinae plane block group)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Maximum inspired volume
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 Outcome Measures

Daily and total rescue analgesics consumption.
Need for rescue analgesia and the total consumption of morphine in the form of incremental doses (0.05mg /kg) if Visual Analogue Score (VAS) ≥4 Pain score will be measured by Visual Analogue Score (VAS) from 0 to 10. Where 0: no pain, 10: the worst pain
Intensive care length of stay.
Time from admission till Intensive care discharge
Hospital length of stay.
Time from admission till Hospital discharge
pH
pH will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
PaO2
PaO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
PaCo2
PaCo2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
FiO2
FiO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
Respiratory rate
Respiratory rate will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
Adverse effects and complications.
Adverse effects and complications such as hypotension, complications related to catheter insertion, pneumothorax, local anesthetic toxicity, and respiratory depression

Full Information

First Posted
October 3, 2023
Last Updated
October 18, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT06088836
Brief Title
Ultrasound- Guided Continuous Retro Laminar Block Versus Continuous Erector Spinae Plane Block in Multiple Rib Fractures
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retrolaminar Block, Erector Spinae Plane Block, Spirometry, Pain, Multiple Rib Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (Retrolaminar block group)
Arm Type
Experimental
Arm Description
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
Arm Title
Group II (Erector spinae plane block group)
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Retrolaminar block group
Intervention Description
Under complete aseptic precautions and sterilization and in sitting position, A high-frequency linear ultrasound probe (6-11 MHz) was placed into a longitudinal orientation in the paraspinous line 1 cm from the midline. Lamina appeared as a continuous line interrupted by the intra laminar spaces. local infiltration of needle insertion site with 3ml of 2.0 % lidocaine was done Then, an 18-gauge Tuohy needle was inserted in plane 1 cm lateral to the spinous process using ultrasound imaging and advanced caudally or cranially until it contacts the lamina.
Intervention Type
Drug
Intervention Name(s)
Erector spinae plane block group.
Intervention Description
Under complete aseptic precautions and sterilization and in sitting position, A high-frequency ultrasound transducer was placed in a longitudinal orientation 3 cm lateral to the midline midway between the uppermost and the lowest fractured rib to identify counting of ribs using ultrasound three muscles were identified as superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. However, when the rhomboid major muscle disappears this indicates that we are at the level of the seventh thoracic vertebra. local infiltration of needle insertion site with 3ml of 2.0 % lidocaine was done. Then, an 18-gauge Tuohy needle was inserted in cranial-caudal direction towards transverse process (TP) in-plane to the US transducer until needle touched the TP crossing all the muscles
Primary Outcome Measure Information:
Title
Maximum inspired volume
Description
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.
Time Frame
4 days after intervention.
Secondary Outcome Measure Information:
Title
Daily and total rescue analgesics consumption.
Description
Need for rescue analgesia and the total consumption of morphine in the form of incremental doses (0.05mg /kg) if Visual Analogue Score (VAS) ≥4 Pain score will be measured by Visual Analogue Score (VAS) from 0 to 10. Where 0: no pain, 10: the worst pain
Time Frame
24 hours after intervention.
Title
Intensive care length of stay.
Description
Time from admission till Intensive care discharge
Time Frame
28 days after intervention
Title
Hospital length of stay.
Description
Time from admission till Hospital discharge
Time Frame
28 days after intervention
Title
pH
Description
pH will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
Time Frame
4 days after intervention.
Title
PaO2
Description
PaO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
Time Frame
4 days after intervention.
Title
PaCo2
Description
PaCo2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
Time Frame
4 days after intervention.
Title
FiO2
Description
FiO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
Time Frame
4 days after intervention.
Title
Respiratory rate
Description
Respiratory rate will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
Time Frame
4 days after intervention.
Title
Adverse effects and complications.
Description
Adverse effects and complications such as hypotension, complications related to catheter insertion, pneumothorax, local anesthetic toxicity, and respiratory depression
Time Frame
4 days after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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. Uncooperative patients and patients with psychiatric illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hossam I Ibrahim, Master
Phone
00201093230200
Email
hossam.hesham@med.tanta.edu.eg
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hossam I Ibrahim, Master
Phone
00201093230200
Email
hossam.hesham@med.tanta.edu.eg
First Name & Middle Initial & Last Name & Degree
Thanaa M Elnoamany, MD
First Name & Middle Initial & Last Name & Degree
Ayman A Yousef, MD
First Name & Middle Initial & Last Name & Degree
Rehab S Elkalla, MD
First Name & Middle Initial & Last Name & Degree
Wail E Messbah, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
After the end of study for one year.
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Learn more about this trial

Ultrasound- Guided Continuous Retro Laminar Block Versus Continuous Erector Spinae Plane Block in Multiple Rib Fractures

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