Rhomboid Intercostal and Sub-Serratus Block for Improving Pulmonary Function and Pain in Patients With Fracture Ribs

NCT ID: NCT05898958

Last Updated: 2023-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2023-09-30

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.

Conditions

Fracture Rib

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

I.v morphine infusion

A loading i.v. dose of 0.15 mg/kg morphine sulphate diluted in 10 ml of normal saline was given slowly over4-5 min. Then, the morphine infusion will be started bysyringe pump in a dose of 0.05 mg/kg/h that wastitrated to keep the VAS less than 3 at rest andRamsay Sedation Scale (RSS) up to 4

Group Type: NO_INTERVENTION

No interventions assigned to this group

Thoracic paravertebral block(TPVB)

Procedure/Surgery: thoracic paravertebral block The block will be performed in the lateral position.After skin sterilization,the ultrasound transducerprobe (6-13-MHz high-frequency linear transducer) is positioned in the vertical plane ∼2.5 cm lateral tomarked spinous process with its orientation directedcranially. T.After local anesthetic infiltration, an 18-gauge Tuohy needle will be inserted into the paravertebral spacein an 'in plane' technique. After a negativeaspiration through the needle, 20 ml of 0.25%bupivacaine with 1: 200 000 epinephrine will be injected slowly over 3 min.A20-G epidural catheter will be threaded through Tuohyneedle and advanced 2-3 cm into the paravertebral space.Anyprocedure-related adverse effects will be noted, and thedermatomal loss of pin prick sensation will be testedover both sides.

Group Type: EXPERIMENTAL

thoracic paravertebral block

Intervention Type: PROCEDURE

The block will be performed in the lateral position.After skin sterilization,the ultrasound transducerprobe (6-13-MHz high-frequency linear transducer) is positioned in the vertical plane ∼2.5 cm lateral tomarked spinous process with its orientation directedcranially. T.After local anesthetic infiltration, an 18-gauge Tuohy needle will be inserted into the paravertebral spacein an 'in plane' technique. After a negativeaspiration through the needle, 20 ml of 0.25%bupivacaine with 1: 200 000 epinephrine will be injected slowly over 3 min.A20-G epidural catheter will be threaded through Tuohyneedle and advanced 2-3 cm into the paravertebral space.Anyprocedure-related adverse effects will be noted, and thedermatomal loss of pin prick sensation will be testedover both sides.

Rhomboid Intercostal , subserratus block (RISSB)

The ultrasound probe will be placed in the obliquesagittal plane orientation, 1-2 cm medial to the medial scapula at theT5-T6 level. The trapezius muscle, rhomboid major muscle, ribs, intercostal muscle and pleura will be visualized respectively using ultrasound.After local anesthetic infiltration, needle will be inserted from the cranial to the caudal direction using the in-plane technique. The needle will be advanced between the rhomboid major and intercostal muscle fascia. The location of the needle will be confirmed with 2 mL saline solution, 10 ml of 0.25% bupivacaine with 1 : 200 000 epinephrine will beinjected slowly over 3min.for the subserratus block 10 ml of 0.25%bupivacaine with 1 : 200 000 epinephrine will be injected betweenthe serratus and intercostal muscle fascia at level of t9.

Group Type: EXPERIMENTAL

rhomboid intercostal and subserratus block

Intervention Type: PROCEDURE

The ultrasound probe will be placed in the obliquesagittal plane orientation, 1-2 cm medial to the medial scapula at theT5-T6 level. The trapezius muscle, rhomboid major muscle, ribs, intercostal muscle and pleura will be visualized respectively using ultrasound.After local anesthetic infiltration, needle will be inserted from the cranial to the caudal direction using the in-plane technique. The needle will be advanced between the rhomboid major and intercostal muscle fascia. The location of the needle will be confirmed with 2 mL saline solution, 10 ml of 0.25% bupivacaine with 1 : 200 000 epinephrine will beinjected slowly over 3min.for the subserratus block 10 ml of 0.25%bupivacaine with 1 : 200 000 epinephrine will be injected betweenthe serratus and intercostal muscle fascia at level of t9.

Interventions

thoracic paravertebral block

The block will be performed in the lateral position.After skin sterilization,the ultrasound transducerprobe (6-13-MHz high-frequency linear transducer) is positioned in the vertical plane ∼2.5 cm lateral tomarked spinous process with its orientation directedcranially. T.After local anesthetic infiltration, an 18-gauge Tuohy needle will be inserted into the paravertebral spacein an 'in plane' technique. After a negativeaspiration through the needle, 20 ml of 0.25%bupivacaine with 1: 200 000 epinephrine will be injected slowly over 3 min.A20-G epidural catheter will be threaded through Tuohyneedle and advanced 2-3 cm into the paravertebral space.Anyprocedure-related adverse effects will be noted, and thedermatomal loss of pin prick sensation will be testedover both sides.

Intervention Type: PROCEDURE

rhomboid intercostal and subserratus block

The ultrasound probe will be placed in the obliquesagittal plane orientation, 1-2 cm medial to the medial scapula at theT5-T6 level. The trapezius muscle, rhomboid major muscle, ribs, intercostal muscle and pleura will be visualized respectively using ultrasound.After local anesthetic infiltration, needle will be inserted from the cranial to the caudal direction using the in-plane technique. The needle will be advanced between the rhomboid major and intercostal muscle fascia. The location of the needle will be confirmed with 2 mL saline solution, 10 ml of 0.25% bupivacaine with 1 : 200 000 epinephrine will beinjected slowly over 3min.for the subserratus block 10 ml of 0.25%bupivacaine with 1 : 200 000 epinephrine will be injected betweenthe serratus and intercostal muscle fascia at level of t9.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ahmed Raafat Mansour Saif Elbalat

Assistant lecturer in anesthesia,icu and pain department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sanaa A Eltohamy

Role: STUDY_DIRECTOR

Zagazig University

Locations

Zagazig

Zagazig, , Egypt

Site Status: RECRUITING

Zagazig

Zagazig, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed R Elballat, Master

Role: CONTACT

loyalman54@gmail.com

01097785845 ext. 002

Facility Contacts

Shereen E Abdellatif, MD

Role: primary

shosh.again@gmail.com

01007948840 ext. 002

Other Identifiers

9001-17-10-2021

Identifier Type: -

Identifier Source: org_study_id