Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT07493473 for Discitis of Thoracic Region is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Parascapular Sub Iliocostalis Plane Block Versus Thoracic Paravertebral Plane Block for Traumatic Multiple Rib Fractures 36
Clinical Trial NCT07493473 is an interventional study for Discitis of Thoracic Region that is active, not recruiting. It started on 1 May 2025 with plans to enroll 36 participants. Led by Zagazig University, it is expected to complete by 1 August 2026. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
Pain control of rib fractures is essential for not only primary pain relief but also preventing secondary complications such as atelectasis or pneumonia which increase the hospital stay, as well as the transition to chronic pain.
The cornerstones of analgesic management are oral and intravenous medications such as paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids as well as regional block techni...
Show MoreDetailed Description
The cases will be randomly selected from Zagazig University emergency Hospital with unilateral multiple rib fractures who admitted to thoracic surgery and emergency departments.
All Cases Will Undergo:
• Patient Examination: All participating patients will be interviewed during their preparation. The goal and end points of the study will be discussed with them. Understanding of the blocks will be reviewed and empha...
Show MoreOfficial Title
Continuous Block of Parascapular Sub-Iliocostalis Plane Versus Thoracic Paravertebral Plane for Analgesia in Patients With Traumatic Multiple Rib Fractures
Conditions
Discitis of Thoracic RegionOther Study IDs
- ZU-IRB #1139
NCT ID Number
Start Date (Actual)
2025-05-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2026-08
Enrollment (Estimated)
36
Study Type
Interventional
PHASE
N/A
Status
Active, not recruiting
Keywords
Paravertebral block
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorGroup 1 (TPV) patients will receive ultrasound guided continuous thoracic paravertebral nerve block | Thoracic paravertebral block Site of injection is two segments below the most cephalad fractured rib. The midpoint of the transducer is placed in a longitudinal paramedian plane between two transverse processes of chosen vertebral level. An 18 G needle is introduced using out of plane . The tip of the needle is advanced under vision till it pierces the superior costotransverse ligament. 5 ml of bupivacaine 0.25% is injected after negative aspira...Show More |
Active ComparatorGroup 2 (PSIB) patients will receive ultrasound-guided continuous parascapular subiliocostalis plane block | Parascapular Sub-Iliocostalis Plane Block While seated with arms draped over body, the patient will receive the PSIB. A linear ultrasound probe is positioned in a parasagittal plane, at the level of the scapular spine edge, 2 cm from the medial scapular border (fourth rib level). An examination of the trapezius, rhomboid major, iliocostalis, and intercostal muscles is conducted, encompassing both the superficial and deep layers of muscle tissue. By employing...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
pain intensity using VAS. | Patients will be instructed to evaluate pain scores by visual analog scale (VAS), which is a simple assessment tool consisting of a 10-cmline, where 0=no pain at all, 1-2=mild pain intensity,3-5=moderate pain intensity, 6-8=severe pain intensity, and 9-10=worst pain was felt. | VAS score will be recorded just before analgesia, post block at hour1, hour12 , hour24 and hour48 at rest and on coughing. |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
inspiratory exercise tolerance by using Hand-held volume targeted incentive spirometry | Patients will be asked to take five deep breaths through incentive spirometers then each breath will take one point and then points and inhaled volumes will be documented in a table (No. of breaths, tidal volume (600,900,1200, ml as marked on the spirometer) | immediately before analgesia, post block at hour1, hour12, hour24 and hour48 |
peak expiratory flow rate | Assess respiratory functions by peak expiratory flow meter (PEFR) | immediately before analgesia, post block at hour1, hour12, hour24 and hour48 |
Patient satisfaction | Degree of patient satisfaction will be assessed and recorded as follows:
* 1.Completely satisfied
* 2.Satisfied
* 3.Neither satisfied nor unsatisfied
* 4.Completely unsatisfied | at hour 48 |
amount of total opioid consumption | total amount of opioid consumption in 48 hours in block groups starting from the beginning of the local anesthetic block will be recorded | in 48 hours in block groups starting from the beginning of the local anesthetic block. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult
Minimum Age
21 Years
Eligible Sexes
All
- Patient written informed consent.
- ASA I to III.
- Age 21-60 years old.
- Gender: Both.
- BMI < 35 Kg/M2.
- Accepted mental state of the patient.
- Patient with unilateral multiple rib fractures (≥2 fractures)
- Any trauma in the patient that interfere with the positioning of patients for block.
- Patients who needed mechanical ventilation before or during the study.
- Patients with associated head trauma.
- Patient with hemodynamic instability and need inotropic support. • Patient with abbreviated injury scale (AIS) in extremity more than 2 (10)
- Pathological coagulopathy.
- Infection at the injection site.
- Disturbed conscious level.
- An allergy to local anesthetics or any used drugs in this study.
- Pregnancy.
No contact data.
1 Study Locations in 1 Countries
Sharqia Province
Zagazig university, Zagazig, Sharqia Province, 44111, Egypt