- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06757803
The Analgesic Effect of Retro-laminar Block Versus Paravertebral Block in Patients With Multiple Fracture Ribs
Rib fractures are a common injury, occurring in up to 10% of all trauma patients. Multiple rib fractures can be particularly painful and debilitating, making it difficult for patients to breathe and cough. This can lead to complications such as atelectasis, pneumonia, and respiratory failure.
Adequate pain control is essential for patients with rib fractures. This can help to improve respiratory function, reduce the risk of complications, and speed up recovery.
Paravertebral block (PVB) is a regional anaesthetic technique that is commonly used for pain management in patients with rib fractures. It involves injecting local anaesthetics into the paravertebral space, which is a region of tissue located between the transverse processes of the vertebrae and the pleura. PVB is an effective way to block the sensory nerves that supply the thoracic region, including the ribs.
However, PVB can be technically challenging to perform, and there is a risk of complications such as pneumothorax and pleural puncture.
Retrolaminar block (RLB) is a newer regional anaesthetic technique that has been proposed as an alternative to PVB for pain management in patients with rib fractures. RLB involves injecting local anaesthetics into the retrolaminar space, which is a region of tissue located between the lamina of the vertebra and the epidural space.
RLB is thought to be easier to perform than PVB, and there is a lower risk of complications. However, there is limited studies support the use of RLB for pain management in patients with rib fractures.
The primary objective of this research is to compare the analgesic efficacy of retrolaminar block (RLB) and paravertebral block (PVB) in patients with fracture ribs.
Secondary objectives include:
- To compare the safety of RLB and PVB
- To compare the duration of analgesia provided by RLB and PVB
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rib fractures are a common injury, occurring in up to 10% of all trauma patients. Multiple rib fractures can be particularly painful and debilitating, making it difficult for patients to breathe and cough. This can lead to complications such as atelectasis, pneumonia, and respiratory failure.
Adequate pain control is essential for patients with rib fractures. This can help to improve respiratory function, reduce the risk of complications, and speed up recovery.
Paravertebral block (PVB) is a regional anaesthetic technique that is commonly used for pain management in patients with rib fractures. It involves injecting local anaesthetics into the paravertebral space, which is a region of tissue located between the transverse processes of the vertebrae and the pleura. PVB is an effective way to block the sensory nerves that supply the thoracic region, including the ribs.
However, PVB can be technically challenging to perform, and there is a risk of complications such as pneumothorax and pleural puncture.
Retrolaminar block (RLB) is a newer regional anaesthetic technique that has been proposed as an alternative to PVB for pain management in patients with rib fractures. RLB involves injecting local anaesthetics into the retrolaminar space, which is a region of tissue located between the lamina of the vertebra and the epidural space.
RLB is thought to be easier to perform than PVB, and there is a lower risk of complications. However, there is limited studies support the use of RLB for pain management in patients with rib fractures.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Asyut, Egypt
- Assiut University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
* Age 18 years or older
- American Society of Anesthesiologists (ASA) physical status I-III
- Rib fractures, as confirmed by X-ray or computed tomography (CT) scan
- Both sexes, males and females.
Exclusion Criteria:
*Patient refusal.
- Infection at the injection site
- Allergy to local anesthetics
- Neurological deficit
- Spinal deformity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group 1
patients will be subjected to rertrolaminar block
|
Positioning The patient is positioned in a lateral decubitus position with the affected side up. The patient's arm on the affected side is placed behind the head. The patient's spine is aligned and the shoulder is elevated to expose the paravertebral space. *Ultrasound imaging A high-frequency linear ultrasound probe (5-12 MHz) is placed in a paramedian sagittal plane at the desired level of block. The probe is oriented so that the transverse processes are visualized on the lateral side of the screen and the vertebral laminae are visualized on the medial side of the screen. The interlaminar space is visualized as a hypoechoic region between the laminae. *Needle insertion A short bevel block needle (20-22 G) is inserted through the skin at the caudal end of the ultrasound probe, aiming cephalad. The needle is advanced under real-time ultrasound guidance until the tip of the needle contacts the lamina. The needle is then slightly withdrawn and the local anesthetic is injected into t |
|
Experimental: group 2
patients will be subjected to paravertebral block
|
Use a sterile ultrasound-guided needle. Insert the needle in-plane from a lateral to medial direction, aiming for the apex of the paravertebral space. The needle should be advanced until it is just beyond the transverse process. *Test Aspiration Aspirate to ensure that the needle is not in a blood vessel.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total post operative analgesic consumption
Time Frame: 48 hours
|
total analgesic consumption in 1st 48hours
|
48 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
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
- RLB VS PVB fracture ribs
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rib Fracture
-
Zimmer BiometRiverpoint MedicalRecruiting
-
University Hospital MuensterCompletedRib Fractures | Rib Fracture Multiple | Rib Trauma | Thorax; FractureGermany
-
University of California, San DiegoCongressionally Directed Medical Research ProgramsEnrolling by invitationRib Fracture Multiple | Rib FractureUnited States
-
Brittany HoyteActive, not recruitingRib Fractures | Rib Fracture Multiple | Rib TraumaUnited States
-
Zimmer BiometRecruitingRib; FractureAustralia, Korea, Republic of
-
Milton S. Hershey Medical CenterCompletedTrauma | Rib Fracture
-
Brigham and Women's HospitalCompletedTraumatic Rib FractureUnited States
-
Darwin AngRecruitingFlail Chest | Rib FractureUnited States
-
University of California, San DiegoCompleted
-
Zagazig UniversityCompleted
Clinical Trials on rertrolaminar block
-
Uludag UniversityRecruitingPostoperative Pain | Patient Outcome Assessment | Sternotomy | Nerve BlockTurkey (Türkiye)
-
Erzincan UniversityRecruitingTotal Knee Arthroplasty | Post Operative AnalgesiaTurkey (Türkiye)
-
Huazhong University of Science and TechnologyRecruitingPain, Acute | Nerve Block | Thoracic AnesthesiaChina
-
Ain Shams UniversityCompleted
-
National Cancer Institute, EgyptCompleted
-
University of FloridaUnited States Department of Defense; Brooks RehabilitationCompleted
-
Cumhuriyet UniversityCompleted
-
Kyungpook National University HospitalCompletedPain | Radicular; Neuropathic, Cervical
-
Dr Abdurrahman Yurtaslan Ankara Oncology Training...CompletedCoronary Artery Bypass GraftingTurkey (Türkiye)
-
Kirsehir Ahi Evran UniversitesiNot yet recruitingPostoperative Pain | Total Hip Arthroplasty (THA)