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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • 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

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
Intervention / Treatment
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

Outcome Measure
Measure Description
Time Frame
Intraoperative opioid consumption.
Time Frame: Intraoperative period
Intraoperative opioid consumption will be recorded.
Intraoperative period

Secondary Outcome Measures

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

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

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 (Estimated)

July 15, 2025

Primary Completion (Estimated)

August 20, 2025

Study Completion (Estimated)

September 10, 2025

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 25, 2024

First Posted (Actual)

December 27, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID 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

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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