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Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.

Primary Purpose

Rib Fractures, Analgesia

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Serratus anterior plane block

Thoracic Paravertebral block

Control

About this trial

This is an interventional prevention trial for Rib Fractures focused on measuring Fracture rib, TPVB, SAPB

Eligibility Criteria

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

Inclusion Criteria:

ASA 1_3 Age 18_60 Unilateral fracture ribs

Exclusion Criteria:

Drug allergy Morbid obese Opioid dependence Patients refuse

Sites / Locations

Minia university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Serratus anterior plane block

Thoracic Paravertebral block

Control group

Arm Description

20 patients will receive SAP block with 0.4 ml / kg bupivacaine 0.125% then continuous infusion through a catheter at rate of 7 ml / hour to max 10 ml / hour of bupivacaine 0.0625%

20 patients will receive TPVB 0.4ml / kg bupivacaine 0.125% then continuous infusion through a catheter at rate of 7 ml / hour to max 10 ml / hour of bupivacaine 0.0625%

20 patients will receive Fentanyl patch 50 microgram

Outcomes

Primary Outcome Measures

VAS score

Visual analogue pain score describe by the patient

Secondary Outcome Measures

Total analgesic consumption

Total opioid consume by the patient in 24 hour

Full Information

NCT ID

NCT04554186

First Posted

September 12, 2020

Last Updated

September 22, 2020

Sponsor

Minia University

1. Study Identification

Unique Protocol Identification Number

NCT04554186

Brief Title

Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.

Official Title

Ultrasound Guided Serratus Anterior Plane Block Versus Thoracic Paravertebral Block in Emergency Department Rib Fracture

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 22, 2020 (Actual)

Primary Completion Date

January 1, 2021 (Anticipated)

Study Completion Date

January 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Compare between serratus anterior plane block and thoracic Paravertebral block in analgesia for patients with multiple rib fractures

Detailed Description

The study will be conducted in a prospective randomised controlled. Patients will be allocated into three groups Control group: The patient will receive fentanyl patch 50 microgram TPVB group: The patient will receive thoracic vertebral plane lock 0.4ml/kg bupivacaine 0.1 25% will be administered. For continuous infusion catheter will be inserted . Then a rate of 7ml / hour to max 10 ml / hour of bupivacaine 0.0625% SAPB group,: Patient will receive serratus anterior plane block 0.4ml / kg bupivacaine 0.125% will be injected to open the space then a catheter will be advanced For continuous infusion of 0.0625 % bupivacaine at 7 ml / hour

6. Conditions and Keywords

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

Rib Fractures, Analgesia

Keywords

Fracture rib, TPVB, SAPB

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Serratus anterior plane block

Arm Type

Experimental

Arm Description

20 patients will receive SAP block with 0.4 ml / kg bupivacaine 0.125% then continuous infusion through a catheter at rate of 7 ml / hour to max 10 ml / hour of bupivacaine 0.0625%

Arm Title

Thoracic Paravertebral block

Arm Type

Active Comparator

Arm Description

20 patients will receive TPVB 0.4ml / kg bupivacaine 0.125% then continuous infusion through a catheter at rate of 7 ml / hour to max 10 ml / hour of bupivacaine 0.0625%

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

20 patients will receive Fentanyl patch 50 microgram

Intervention Type

Procedure

Intervention Name(s)

Serratus anterior plane block

Intervention Description

Injection of bupivacaine between serratus anterior plane and latissimus dorsi muscle using ultrasound

Intervention Type

Procedure

Intervention Name(s)

Thoracic Paravertebral block

Intervention Description

Injection of bupivacaine in the thoracic Paravertebral space using ultrasound

Intervention Type

Procedure

Intervention Name(s)

Control

Intervention Description

Place a fentanyl patch 50 microgram

Primary Outcome Measure Information:

Title

VAS score

Description

Visual analogue pain score describe by the patient

Time Frame

24 hour

Secondary Outcome Measure Information:

Title

Total analgesic consumption

Description

Total opioid consume by the patient in 24 hour

Time Frame

24 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ASA 1_3 Age 18_60 Unilateral fracture ribs Exclusion Criteria: Drug allergy Morbid obese Opioid dependence Patients refuse

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed G Shehata, Master

Phone

1067622270

Ext

0020

ahmedgamalicu@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Omyma M Shehata, MD

Phone

1061762894

Ext

0020

Omyma.shehata44@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amany K Aboelhassan

Organizational Affiliation

Minia University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Minia university hospital

City

Minya

ZIP/Postal Code

61511

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmed G Shehata, Master

Phone

1067622270

Ext

0020

ahmedgamalicu@gmail.com

First Name & Middle Initial & Last Name & Degree

Omyma M Shehata, MD

Phone

1061762894

Ext

0020

omyma.shehata44@yahoo.com

12. IPD Sharing Statement

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Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.

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