Serratus Anterior Plane (SAP) Block vs SAP Block Combined With Transverus Thoracic Plane (TTP) Block, for Post-mastectomy Pain Control.

June 1, 2022 updated by: Ahmed wahby Shamsedine, Assiut University

Comparison Between Serratus Anterior Plane Block, and Transversus Thoracic Plane Block Combined With Serratus Anterior Plane Block, for the Management of Post-mastecomy Pain.

a comparison shall be conducted between Serratus anterior plane block, on one hand, and transversus thoracic plane block combined with Serratus anterior plane block, on the other hand for management of post-mastectomy pain. VAS "Visual Analogue Scale" score will be compared in both case, and control groups.

Study Overview

Status

Status

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

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

Breast cancer is one of the most common cancers in women all over the world. In the united states, according to the CDC "Center of Disease Control", it's the second most common cancer occurring in women. Perioperative pain after breast surgeries remains to be taken lightly due to the minimal invasiveness of breast surgeries. However, it is estimated that 25-60% of patients undergoing breast cancer related surgeries develop chronic pain. Acute post-operative pain remains an important risk factor in developing chronic post-mastectomy pain; about 40% of women will have acute post-operative pain, on the other hand, 50% will have chronic pain. Different regional anaesthesia techniques have achieved better management of post-breast surgery acute pain and subsequently less frequent chronic pain. Add to that, effective regional anaesthesia will decrease both the surgical stress response and the requirements of general anaesthetics and opioids, which will keep the function of the immune system intact. A lot of regional anaesthesia techniques have been used to control anterior chest wall pain as the pectoral nerves (PECs) block, paravertebral block, intercostal nerve blocks, thoracic epidural analgesia, serratus anterior plane block. The breast receives its innervation through the anterior and lateral cutaneous branches of the 2nd to the 6th intercostal nerves. Targeting the serratus plane is a safer and a simpler procedure than multiple intercostal or paravertebral blocks. As a setback for the serratus anterior plane block, it only blocks the lateral cutaneous branches of the intercostal nerves with minimal if any effect on the anterior cutaneous branches. The serratus anterior plane block, being unable to block the anterior cutaneous branches of the intercostal nerves, have to be combined with another technique, transversus thoracic plane block, which can block them. The investigators here are trying to measure the efficacy of the combined serratus anterior plane block and tranversus thoracic plane block on the management of post-mastectomy pain.

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 (Actual)

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.
54

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 Locations

  • Egypt
      • Assiut, Egypt
        • South Egypt Cancer Institute, Assiut University

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

30 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Adult female patients > 30 years old, ASA "American Society of Anaesthesiologists" physical status I or II undergoing any unilateral mastectomy.

Exclusion Criteria:

  • Patient's refusal.
  • Known contraindications to regional blocks, including local skin infections,and coagulopathy.
  • Allergies to the local anaesthetics 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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Active Comparator: SAP block for management of post-mastectomy pain
the patients in this group shall undergo Serraturs anterior plane block for management of post-mastectomy pain.
Procedure: Serratus anterior plane block
•Serratus anterior plane block will be carried out with the patient lying in the lateral position. After skin disinfection, the ultrasound probe will be applied parallel to and between the 5th and 6th ribs in the mid axillary region, for identification of the superficial latissimus dorsi muscles and deep anterior serratus muscles. Then, 25 ml of isobaric bupivacaine 0.25% will be injected above the serratus anterior muscle.
Other Names:
  • SAP block
Active Comparator: TTP block combined with SAP block for post-mastectomy pain
the patients in this group shall undergo combined Serraturs anterior plane block, and Transversus thoracic plane block for management of post-mastectomy pain.
Procedure: Serratus anterior plane block
•Serratus anterior plane block will be carried out with the patient lying in the lateral position. After skin disinfection, the ultrasound probe will be applied parallel to and between the 5th and 6th ribs in the mid axillary region, for identification of the superficial latissimus dorsi muscles and deep anterior serratus muscles. Then, 25 ml of isobaric bupivacaine 0.25% will be injected above the serratus anterior muscle.
Other Names:
  • SAP block
Procedure: Transversus thoracic plane block
•Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, the ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of isobaric bupivacaine 0.25% will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
Other Names:
  • TTP block

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
Total sum of used IV additional opioid analgesia.
Time Frame: 24 hours post-operatively
If the patient experiences a pain of > 3, IV morphine will be given at a dose of 2.5-5 mg per dose, with a maximum dose of 10 mg, aiming for a pain score of ≤ 3. the total morphine dose for the post-operative 24 hours will be compared between the case and control group, in order to determine which technique provided more analgesia.
24 hours post-operatively

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
Post-operative pain score
Time Frame: 24 hours post-operatively
VAS (Visual Analogue Scale, 0-100 mm; where 0 = no pain, and 100 = worst imaginable pain) will be assessed, at rest, per hour for 24 hours post operatively. Moreover, VAS will also be assessed at 12 and 24 hours post-operatively while abducting the ipsilateral arm. If the patient experiences a pain of > 3, IV morphine will be given at a dose of 2.5-5 mg per dose, with a maximum dose of 10 mg, aiming for a pain score of ≤ 3.
24 hours post-operatively

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.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Zein El-Abdeen Z Hassan, Professor, Assiut university hospitals
  • Study Director: Montasser A Mohamed, A.Professor, South Egypt Cancer Institute, Assiut University Hospitals.
  • Study Director: Ahmed H Othman, A.Professor, South Egypt Cancer Institute, Assiut University Hospitals.
  • Principal Investigator: Ahmed W Mohamed Shamsedine, MBBCH, South Egypt Cancer Institute, Assiut University Hospitals.

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

Helpful Links

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.
June 15, 2021

Primary Completion (Actual)

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.
March 15, 2022

Study Completion (Actual)

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.
April 30, 2022

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).
May 1, 2020

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.
May 4, 2020

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.
May 5, 2020

Study Record Updates

Last Update Posted (Actual)

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.
June 3, 2022

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.
June 1, 2022

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.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • post-mastectomy pain control

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

the decision shall be taken at the end of the study. I anticipate that it is going to be a "yes".

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.

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