Clinical trial NCT05898958: Rhomboid Intercostal and Sub-Serratus Block for Improving Pulmonary Function and Pain in Patients With Fracture Ribs
Official title: Impact of Ultrasound-Guided Rhomboid Intercostal and Sub-Serratus Block Versus Thoracic Paravertebral Block on Improving Pulmonary Functions for Multiple Rib Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture Rib
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-06-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rib fractures are seen in more than 50% of patient spresenting with blunt chest trauma and are associated with significant morbidity, long-term disability and mortality .

Many of these adverse consequences are a result ofinadequately controlled pain which hinders respiration,leading to atelectasis, pneumonia and respiratory failure .

The early provision of adequate analgesia is thereforeparamount in the management of these patients. The cornerstones of analgesic management are oral andintravenous medications such as paracetamol, nonsteroidal anti-inflammatorydrugs(NSAIDs) and opioids.

Nevertheless, in patients with more significant injuries orcomorbidities, interventional procedures are often neededto provide adequate analgesia and avoid opioid-relatedadverse effects .

Detailed description: Paravertebral block (PVB), through injecting a local anaesthetic agent close towhere the spinal nerves exit the intervertebral foramina, can provide high quality ipsilateral, segmental, somatic, and sympathetic nerve blockad.

PVB is a successful regional method for amelioration of pain in patients undergoingesophagectomy, breastsurgery, thoracotomy, cardiacsurgery,hepatectomy,percutaneusnephrolithotomyand nephrectomy .Thoracic paravertebralblock(TPVB) has also been used for pain reliefof multiplerib fractures ( MRFs).

Rhomboid intercostal and sub-serratus block (RISS) is an alternative block for multiple rib fractures.

The rhomboid intercostal block was first described in 2016 . The region described is known as the triangle of auscultation that is bounded medially by inferior part of the trapezius, inferiorly by the superior border oflatissimusdorsi, and laterally by the medial border of the scapula. In this ultrasound-guided block, the local anesthetic drug is administered between the rhomboid major and the intercostal muscle fascia at the level of T6-T7 and provides analgesia of T3-T8 dermatomes .

Elsharkawy et al. described a modification to the rhomboid intercostal block to expand dermatomal coverage fromT2-T11 dermatomes. They describe theRISS (Rhomboid Intercostal and Sub-Serratus) block that is a twoinjection block of both the rhomboidintercostal and sub-serratusspace. After the first injection, theultrasound probe advances caudally and laterally distal to the inferior angle of the scapula, the second injection apply between the serratus and intercostal muscle fascia.

Because comparison betweenTPVB and RISS in patients with MRF has rarely been reported.Therefore, this study aimed to assess theeffect ofRISS on pain managementand pulmonary functions compared with TPVB in patients withMRFs.

Eligibility criteria: Inclusion Criteria:

* writteninformedconsentfrom the patient.
* Patient with unilateral multiple rib fractures(≥3fractures). ASA I and II . Age 18-60 years old. Both gender. BMI 25- 30 Kg/m2. Cooperative patients.

Exclusion Criteria:

* Compromised airway. 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 Peripheral neuropathy. Pathological coagulopathy. Infection at the injection site. Untreated pneumothorax. Disturbed conscious level. An allergy to local anesthetics used in this study. Endocrinaldiseases including DM

Primary outcomes:
measure: Pulmonary function test FEV1 by using Hand-held spirometry
timeFrame: 3 days
measure: The visual analog scale (VAS)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig
city: Zagazig
country: Egypt
facility: Zagazig
Study officials:
affiliation: Zagazig University
name: Sanaa A Eltohamy
role: STUDY_DIRECTOR
References: