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

March 29, 2024 updated by: Ali Ahiskalioglu, Ataturk University

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Erzurum, Turkey, 25100
        • Ali Ahiskalioglu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. American Society of Anesthesiologist's physiologic state I-III patients
  2. To undergo Mastectomy Surgery
  3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: group serratus
preoperative superficial serratus block with local anaesthetics and parasternal block with saline
preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml saline
Active Comparator: group serratus and parasternal
preoperative superficial serratus block and parasternal block with local anaesthetics
preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml %0.25 Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative opioid consumption
Time Frame: first 24 hours
First 24 hours total fentanyl consumption with patient controlled analgesia
first 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory Assessment
Time Frame: 24 hours
Sensory Assessment will be performed on patients following the block procedure with pinprick test.
24 hours
Visual analog pain score
Time Frame: First 24 hours
Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score
First 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Hüsnü Kürşad, Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ataunibreastanalgesia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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