Ultrasound- Guided Continuous Retro Laminar Block Versus Continuous Erector Spinae Plane Block in Multiple Rib Fractures
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 Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
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. |
|
Experimental: 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
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
4 days after intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Daily and total rescue analgesics consumption.
Time Frame: 24 hours after intervention.
|
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
|
24 hours after intervention.
|
|
Intensive care length of stay.
Time Frame: 28 days after intervention
|
Time from admission till Intensive care discharge
|
28 days after intervention
|
|
Hospital length of stay.
Time Frame: 28 days after intervention
|
Time from admission till Hospital discharge
|
28 days after intervention
|
|
pH
Time Frame: 4 days after intervention.
|
pH will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
|
4 days after intervention.
|
|
PaO2
Time Frame: 4 days after intervention.
|
PaO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
|
4 days after intervention.
|
|
PaCo2
Time Frame: 4 days after intervention.
|
PaCo2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
|
4 days after intervention.
|
|
FiO2
Time Frame: 4 days after intervention.
|
FiO2 will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
|
4 days after intervention.
|
|
Respiratory rate
Time Frame: 4 days after intervention.
|
Respiratory rate will be measure before the block ,6 hours after the block and then daily for subsequent 4 days.
|
4 days after intervention.
|
|
Adverse effects and complications.
Time Frame: 4 days after intervention.
|
Adverse effects and complications such as hypotension, complications related to catheter insertion, pneumothorax, local anesthetic toxicity, and respiratory depression
|
4 days after intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36264MD35/2/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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