Single-level and Two-level Serratus Posterior Superior Intercostal Plan Block (SPSIPB)

June 30, 2025 updated by: Seyyid Furkan Kına, Ankara Etlik City Hospital

Comparison of Single-level and Two-level Serratus Posterior Superior Intercostal Plan Block (SPSIPB) Applications in the Treatment of Acute Pain After Mastectomy

Breast cancer is the most common malignancy in women; one of the mainstays of breast cancer treatment is surgery, and modified radical mastectomy is one of the standard treatments. Postoperative pain can seriously reduce the quality of life in patients, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abrigation during modified radical mastectomy, but their applications are limited due to the complex nature of the procedures and serious complications. In recent years, regional nerve blocks, including intercostal nerve block, erector spinae plane block (ESPB), and paravertebral block, PECS I-II block, serratus anterior plane block (SAPB), and Serratus Posterior Superior Intercostal Plane Block (SPSIPB), have been applied for the treatment of postmastectomy pain in breast cancer patients. SPSIPB has been frequently used for the treatment of acute pain in the postoperative period following surgeries in the thoracic region. SPSIPB is placed on the spine of the scapula in the sagittal plane to identify the second and third ribs under USG guidance. After visualizing the trapezius and serratus posterior superior (SPS) by moving medially to the upper medial border of the scapula, a block is applied to the depths of the SPS from above the 3rd rib. The applied local anesthetic solution spreads under the SPS muscle. Ipsilateral postoperative analgesia is provided with SPSIPB. SPSIPB can be applied on the 3rd rib in one go, or on the 3rd and 4th ribs in two go. Thus, the local anesthetic solution can be distributed more effectively and more effective postoperative analgesia can be provided.

Study Overview

Status

Status

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Not yet recruiting

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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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.
50

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

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1-Those between the ages of 18-80

2.Those with ASA score I-II-III

3.Those with body mass index (BMI) between 18-40

4.Patients who underwent Single-Level or Two-Level SPSIPB together with mastectomy in the operating room

Exclusion Criteria:

  1. Those under 18 and over 80
  2. Those with ASA score IV and above
  3. Those with advanced co-morbidities
  4. Those with a history of bleeding diathesis
  5. Patients with infection in the area where the block will be performed
  6. Those with BMI under 18 and over 40
  7. Patients who underwent surgery under emergency conditions

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: Quadruple

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: Group Single level SPSIPB
The procedure will be performed with the patient in the prone position in the preoperative period. After the scapula is slightly shifted laterally, the US probe is held sagittally at the upper corner of the scapula spine, and the 3rd rib and the serratus posterior superior muscle will be visualized. In plane technique will be used. The block needle will be advanced in the caudo-cranial direction and entered between the serratus posterior superior and the 3rd rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block location is confirmed, 20 ml of 0.25% bupivacaine will be used.
Procedure: Single level SPSIPB
The procedure will be performed with the patient in the prone position in the preoperative period. After the scapula is slightly shifted laterally, the US probe is held sagittally at the upper corner of the scapula spine, and the 3rd rib and the serratus posterior superior muscle will be visualized. In plane technique will be used. The block needle will be advanced in the caudo-cranial direction and entered between the serratus posterior superior and the 3rd rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block location is confirmed, 20 ml of 0.25% bupivacaine will be used.
Active Comparator: Group Two-level SPSIPB
The block needle will be advanced in the caudo-cranial direction and inserted between the serratus posterior superior and the 2nd rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block location is confirmed, 10 ml of 0.25% bupivacaine will be used. Then, the US probe will be held sagittally in the medial part of the scapula spine, and the 4th rib and serratus posterior superior muscle will be visualized. In plane technique will be used. The block needle will be advanced in the caudo-cranial direction and inserted between the serratus posterior superior and the 4th rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block site is confirmed, 10 ml of 0.25% bupivacaine will be used. A total of 20 ml of 0.25% bupivacaine will be used.
Procedure: Two-level SPSIPB
In plane technique will be used. The block needle will be advanced in the caudo-cranial direction and inserted between the serratus posterior superior and the 2nd rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block location is confirmed, 10 ml of 0.25% bupivacaine will be used. Then, the US probe will be held sagittally in the medial part of the scapula spine, and the 4th rib and serratus posterior superior muscle will be visualized. In plane technique will be used. The block needle will be advanced in the caudo-cranial direction and inserted between the serratus posterior superior and the 4th rib. The block location will be confirmed by injecting 2 ml of saline between the rib and the muscle. After the block site is confirmed, 10 ml of 0.25% bupivacaine will be used. A total of 20 ml of 0.25% bupivacaine will be used.

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
Intraoperative opioid consumption.
Time Frame: Intraoperative period
Intraoperative opioid consumption will be recorded.
Intraoperative period

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
Postoperative 24-hour numeric rating scale
Time Frame: postoperative 24 hours period
Postoperative numeric rating scale will be recorded.(0: no pain-10: severe pain)
postoperative 24 hours period

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.
Ankara Etlik City Hospital

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

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Study Major Dates

Study Start (Estimated)

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.
July 15, 2025

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.
August 20, 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.
September 10, 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).
December 17, 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.
December 25, 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.
December 27, 2024

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.
July 3, 2025

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 30, 2025

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.
December 1, 2024

More Information

Terms related to this study

Keywords

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.
  • AEŞH-EK1-2024-0065

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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