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Università di ZagazigParascapular Sub Iliocostalis Plane Block Versus Thoracic Paravertebral Plane Block for Traumatic Multiple Rib Fractures 36
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La sperimentazione clinica NCT07493473 è uno studio interventistico per Discitis of Thoracic Region, attualmente attivo, non in arruolamento. Avviato il 1 maggio 2025, prevede di arruolare 36 partecipanti. Sotto la guida di l'Università di Zagazig, dovrebbe concludersi entro il 1 agosto 2026. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 25 marzo 2026.
Sommario breve
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...
Mostra di piùDescrizione dettagliata
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...
Mostra di piùTitolo ufficiale
Continuous Block of Parascapular Sub-Iliocostalis Plane Versus Thoracic Paravertebral Plane for Analgesia in Patients With Traumatic Multiple Rib Fractures
Patologie
Discitis of Thoracic RegionAltri ID dello studio
- ZU-IRB #1139
Numero NCT
Data di inizio (effettiva)
2025-05-01
Ultimo aggiornamento pubblicato
2026-03-25
Data di completamento (stimata)
2026-08
Arruolamento (previsto)
36
Tipo di studio
Interventistico
FASE
N.D.
Stato
Attivo, non in arruolamento
Parole chiave
Paravertebral block
Scopo principale
Trattamento
Allocazione
Randomizzato
Modello di intervento
In parallelo
Mascheramento
Doppio
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Comparatore attivoGroup 1 (TPV) patients will receive ultrasound guided continuous thoracic paravertebral nerve block | Blocco paravertebrale toracico 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...Mostra di più |
Comparatore attivoGroup 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...Mostra di più |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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. |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
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. |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto
Età minima
21 Years
Sessi idonei
Tutti
- 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.
Università di Zagazig64 studi clinici attivi da esplorareNessun dato di contatto
1 Centri dello studio in 1 paesi
Sharqia Province
Zagazig university, Zagazig, Sharqia Province, 44111, Egypt