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Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block

Primary Purpose

Rib Fractures, Serratus Anterior Plane Block, Erector Spinae Plane Block

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Serratus Anterior Plane Block
Intercostal Block
Sponsored by
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fractures focused on measuring Rib Fractures, Serratus Anterior Plane Block, Erector Spinae Plane Block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 18 and 65 years
  • American Society of Anesthesiologists physical status I-II-III
  • Body mass index between 18-30 kg/m2
  • Patients with 6 or less rib fractures

Exclusion Criteria:

  • Patient refusing the procedure
  • History of chronic analgesic or opioid therapy
  • History of local anesthetic allergy
  • Infection in the intervention area

Sites / Locations

  • Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Serratus Anterior Plane Block

Intercostal Block

Arm Description

Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique above the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area. The block will be terminated.

The USG probe will be placed at the level of the posterior axillary line and the broken ribs. The ribs, external intercostal muscle, and internal intercostal muscle structures will be imaged. 3 ml of 0.25% bupivacaine will be injected into the subcostal area. This 3 ml 0.25% bupivacaine injection will be administered for each broken rib. The block will be terminated.

Outcomes

Primary Outcome Measures

Pain scores
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.

Secondary Outcome Measures

Need for additional analgesia
Whether the patients need additional analgesia after the block and the amount of additional analgesia needed will be recorded.

Full Information

First Posted
December 3, 2021
Last Updated
January 7, 2023
Sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05160155
Brief Title
Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block
Official Title
Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block for Rib Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
More than 50% of patients presenting with chest trauma experience rib fractures and these rib fractures are associated with significant morbidity, mortality, and long-term disability. Many of these adverse outcomes result from poorly controlled pain that interferes with breathing, leading to atelectasis, pneumonia, and respiratory failure. Therefore, early provision of adequate analgesia is crucial in the management of these patients. The basic stones of analgesic therapy are oral and intravenous drugs such as paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids. However, patients with more significant injuries or comorbidities often require interventional procedures to provide adequate analgesia and avoid opioid-related side effects. Thoracic epidural analgesia and thoracic paravertebral blocks have traditionally been used, but these techniques are associated with side effects and may cause hemodynamic instability. Today, the use of ultrasonography (USG) guided block techniques such as erector spinae plane block (ESPB), serratus anterior plane block (SAPB) and intercostal block (ICB) has increased. These techniques are considered to be simpler and theoretically safer. Although ICB is frequently mentioned in the literature, the publications of new plane blocks such as ESPB and SAPB are new and few in number. In this study, SAPB and ICP to be performed with USG will be evaluated in terms of analgesic effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures, Serratus Anterior Plane Block, Erector Spinae Plane Block, Acute Pain
Keywords
Rib Fractures, Serratus Anterior Plane Block, Erector Spinae Plane Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Serratus Anterior Plane Block
Arm Type
Active Comparator
Arm Description
Following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique above the serratus anterior muscles until the interfascial space was reached. After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine will be injected into the area. The block will be terminated.
Arm Title
Intercostal Block
Arm Type
Active Comparator
Arm Description
The USG probe will be placed at the level of the posterior axillary line and the broken ribs. The ribs, external intercostal muscle, and internal intercostal muscle structures will be imaged. 3 ml of 0.25% bupivacaine will be injected into the subcostal area. This 3 ml 0.25% bupivacaine injection will be administered for each broken rib. The block will be terminated.
Intervention Type
Procedure
Intervention Name(s)
Serratus Anterior Plane Block
Intervention Description
Serratus anterior plane block will be performed unilaterally, under US guidance.
Intervention Type
Procedure
Intervention Name(s)
Intercostal Block
Intervention Description
Intercostal Block will be performed unilaterally, under US guidance.
Primary Outcome Measure Information:
Title
Pain scores
Description
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th and 24th hours after surgery.
Time Frame
24 hours after block
Secondary Outcome Measure Information:
Title
Need for additional analgesia
Description
Whether the patients need additional analgesia after the block and the amount of additional analgesia needed will be recorded.
Time Frame
24 hours after block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18 and 65 years American Society of Anesthesiologists physical status I-II-III Body mass index between 18-30 kg/m2 Patients with 6 or less rib fractures Exclusion Criteria: Patient refusing the procedure History of chronic analgesic or opioid therapy History of local anesthetic allergy Infection in the intervention area
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Musa Zengin, MD
Organizational Affiliation
Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
City
Kecioren
State/Province
Ankara
ZIP/Postal Code
06000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of the Analgesic Efficacy of Serratus Anterior Plane Block and Intercostal Block

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