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Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block Combination for Breast Surgery

Primary Purpose

Analgesia, Cancer, Breast

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

group serratus plan block

group serratus and parasternal plan block

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

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

Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-III patients To undergo Mastectomy Surgery Being between the ages of 18-65 years Exclusion Criteria: Having a known heart, kidney, liver or hematological disease Having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain Routine analgesic use and history of analgesic use in the last 24 hours Not willing to participate in the study Uncooperative patients who have coagulopathy or use anticoagulant drugs To be allergic to one of the drugs to be used

Sites / Locations

Ali AhiskaliogluRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

group serratus

group serratus and parasternal

Arm Description

preoperative superficial serratus block with local anaesthetics and parasternal block with saline

preoperative superficial serratus block and parasternal block with local anaesthetics

Outcomes

Primary Outcome Measures

Postoperative opioid consumption

First 24 hours total fentanyl consumption with patient controlled analgesia

Secondary Outcome Measures

Visual analog pain score

Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score

Sensory Assessment

Sensory Assessment will be performed on patients following the block procedure with pinprick test.

Full Information

NCT ID

NCT05911373

First Posted

May 30, 2023

Last Updated

June 21, 2023

Sponsor

Ataturk University

1. Study Identification

Unique Protocol Identification Number

NCT05911373

Brief Title

Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block Combination for Breast Surgery

Official Title

Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block on Postoperative Opioid Consumption and Dermatomal Analyses for Breast Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 21, 2023 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

January 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Mastectomy is a technique often used in breast cancer surgery. Patients experience moderate to severe pain postoperatively after this procedure. Various plane blocks, NSAIDs, and opioid analgesics can be administered to these patients as components of multimodal analgesia. In the the study, the investigators aimed to evaluate the analgesic effects of the serratus plane block, the parasternal block added to the serratus plane block, and the dermatomal differences.

6. Conditions and Keywords

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

Analgesia, Cancer, Breast

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

group serratus

Arm Type

Placebo Comparator

Arm Description

preoperative superficial serratus block with local anaesthetics and parasternal block with saline

Arm Title

group serratus and parasternal

Arm Type

Active Comparator

Arm Description

preoperative superficial serratus block and parasternal block with local anaesthetics

Intervention Type

Other

Intervention Name(s)

group serratus plan block

Intervention Description

preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml saline

Intervention Type

Other

Intervention Name(s)

group serratus and parasternal plan block

Intervention Description

preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml %0.25 Bupivacaine

Primary Outcome Measure Information:

Title

Postoperative opioid consumption

Description

First 24 hours total fentanyl consumption with patient controlled analgesia

Time Frame

first 24 hours

Secondary Outcome Measure Information:

Title

Visual analog pain score

Description

Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score

Time Frame

First 24 hours

Title

Sensory Assessment

Description

Sensory Assessment will be performed on patients following the block procedure with pinprick test.

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

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

Ali Ahiskalioglu

Phone

+905444424831

aliahiskalioglu@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hüsnü Kürşad

Organizational Affiliation

Ataturk University

Official's Role

Study Director

Facility Information:

Facility Name

Ali Ahiskalioglu

City

Erzurum

ZIP/Postal Code

25100

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ali Ahiskalioglu

Phone

+905444424831

Ext

+905444424831

aliahiskalioglu@hotmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

34733377

Citation

Hu NQ, He QQ, Qian L, Zhu JH. Efficacy of Ultrasound-Guided Serratus Anterior Plane Block for Postoperative Analgesia in Patients Undergoing Breast Surgery: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Pain Res Manag. 2021 Oct 25;2021:7849623. doi: 10.1155/2021/7849623. eCollection 2021.

Results Reference

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PubMed Identifier

31176954

Citation

Piraccini E, Biondi G, Corso RM, Maitan S. The use of rhomboid intercostal block, parasternal block and erector spinae plane block for breast surgery. J Clin Anesth. 2020 Feb;59:10. doi: 10.1016/j.jclinane.2019.06.004. Epub 2019 Jun 6. No abstract available.

Results Reference

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Serratus Plane Block Versus Serratus Plane Block Plus Parasternal Block Combination for Breast Surgery

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