Serratus Anterior Plane Block and Costotransverse Block for Analgesia Following Modified Radical Mastectomy Surgeries

December 6, 2024 updated by: Ain Shams University

Ultrasound Guided Serratus Anterior Plane Block Versus Costotransverse Block on Postoperative Analgesia and Safety Following Modified Radical Mastectomy Surgeries

Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients will be divided randomly by the computer into three groups, group (A): will receive serratus anterior plane block, group (B): will receive costotransverse block and group(C): patient controlled analgesia group (PCA).

Group (A) (SAPB):

SAPB will be performed using an ultrasound machine with a high-frequency linear probe . All patients will be in lateral position to perform the block. At the level of the fourth rib with 45-degree angle, targeting the plane between the latissimus dorsi and serratus muscles, SAPB block will be performed unilaterally on the ipsilateral side of surgery.

Group (B) (CTB):

CTB will be performed using an ultrasound machine with a high-frequency linear probe. All patients will be in lateral position to perform the block. CTB block will be performed unilaterally on the ipsilateral side of surgery at the level of fourth rib.

Group (C) (patient controlled analgesia):

After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt, 154411

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. American Society of Anaesthesiologists (ASA) Physical Status Class I, II.
  2. Scheduled for modified radical mastectomy (MRM).
  3. Body weight ranging from 60 to 100 kilograms.

Exclusion Criteria:

  1. Declining to give a written informed consent.
  2. History of allergy to the medications used in the study.
  3. Contraindications to regional anesthesia (including patient: refusal, coagulopathy, and local infection).
  4. Psychiatric disorders.
  5. Significant cognitive dysfunction.
  6. American Society of Anesthesiologists (ASA) Physical Status Class III and IV.
  7. Daily use of opioids.
  8. Obesity (BMI > 35 kg/m2).

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: serratus anterior plane block
while the patients in lateral position, serratus anterior plane block will be done using high frequency linear ultrasound probe at the level of fourth rib.30 ml of 0.25% bupivacaine will be injected.
Procedure: serratus anterior plane block
using ultrasound, 30 ml of bupivacaine 0.25% will be injected in the plane between the latissimus dorsi and serratus muscles
Experimental: costotransverse plane block
while the patients in lateral position, costotransverse block will be done using 22-gauge echogenic needle. the needle is advanced in-plane lateral to the spinous process of the 4th thoracic vertebra from caudally cephalad.30 ml of 0.25% bupivacaine will be injected
Procedure: costotransverse block
using ultrasound, 30 ml of bupivacaine 0.25% will be injected in the costotransverse plane of fourth rib
Experimental: patient controlled analgesia
After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time.
Procedure: patient controlled analgesia
PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr. with self-administration bolus of 0.5ml with 15 min lock-out time.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale score at 0,6,12 and 24 hour post-operatively. visual analogue scale is a scale from 0 to 10, 0 represent no pain at all and 10 represent the worst pain
Time Frame: 24 hour post-operative
Visual Analogue Scale score will be assessed at both rest and arm elevation
24 hour post-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The total dose of nalbuphine consumption is used postoperatively per patient rescue analgesia for 24.
Time Frame: 24 hour post-operative
dose of nalbuphine consumed by patients
24 hour post-operative
Incidence of chronic pain after 6 months of surgery
Time Frame: 6 months after surgery
How many people develop chronic pain after surgery
6 months after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • analgesia for MRM surgeries

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

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.

Clinical Trials on Regional Anesthesia Morbidity

Clinical Trials on serratus anterior plane block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings