search
Back to results

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

Primary Purpose

Fracture Rib

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
thoracic paravertebral block
rhomboid intercostal and subserratus block
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture Rib

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ZagazigRecruiting
  • ZagazigRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

I.v morphine infusion

Thoracic paravertebral block(TPVB)

Rhomboid Intercostal , subserratus block (RISSB)

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

Pulmonary function test FEV1 by using Hand-held spirometry
Spirometry is the most frequently used measure of lung function and is a measure of volume against time . The spirometer will be used to measure pulmonary function tests namely; FEV1 .Forced expiratory volume (FEV1) measure show how much air a person can exhale in a forced breath during the first second.
The visual analog scale (VAS)
The visual analog scale (VAS) will be used to assess pain severity and control. VAS 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.(22)

Secondary Outcome Measures

Full Information

First Posted
May 14, 2023
Last Updated
June 9, 2023
Sponsor
Zagazig University
search

1. Study Identification

Unique Protocol Identification Number
NCT05898958
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Rib

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I.v morphine infusion
Arm Type
No Intervention
Arm Description
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
Arm Title
Thoracic paravertebral block(TPVB)
Arm Type
Experimental
Arm Description
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.
Arm Title
Rhomboid Intercostal , subserratus block (RISSB)
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
thoracic paravertebral block
Intervention Description
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
Intervention Name(s)
rhomboid intercostal and subserratus block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary function test FEV1 by using Hand-held spirometry
Description
Spirometry is the most frequently used measure of lung function and is a measure of volume against time . The spirometer will be used to measure pulmonary function tests namely; FEV1 .Forced expiratory volume (FEV1) measure show how much air a person can exhale in a forced breath during the first second.
Time Frame
3 days
Title
The visual analog scale (VAS)
Description
The visual analog scale (VAS) will be used to assess pain severity and control. VAS 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.(22)
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed R Elballat, Master
Phone
01097785845
Ext
002
Email
loyalman54@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanaa A Eltohamy
Organizational Affiliation
Zagazig University
Official's Role
Study Director
Facility Information:
Facility Name
Zagazig
City
Zagazig
ZIP/Postal Code
44519
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shereen E Abdellatif, MD
Phone
01007948840
Ext
002
Email
shosh.again@gmail.com
Facility Name
Zagazig
City
Zagazig
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs