Ultrasound-Guided SPSIP Versus ESPB for Postoperative Pain After Modified Radical Mastectomy (SPSIP-ESPB)

March 16, 2026 updated by: Sayed Mahmoud Abed, Cairo University

Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block Versus Erector Spinae Plane Block for Postoperative Pain Management After Modified Radical Mastectomy: A Randomized Clinical Trial

Breast cancer is the most common cancer affecting women worldwide. Modified radical mastectomy is one of the main surgical treatments for breast cancer. However, this surgery is often associated with significant postoperative pain, which may delay recovery and increase the need for opioid medications such as morphine.

Regional anesthesia techniques are increasingly used to improve pain control after breast surgery and reduce opioid consumption. The erector spinae plane block (ESPB) is a well-established ultrasound-guided technique that provides effective chest wall analgesia. The serratus posterior superior intercostal plane (SPSIP) block is a newer ultrasound-guided technique that targets intercostal nerves and may provide effective postoperative pain relief.

The purpose of this randomized clinical trial is to compare the effectiveness of SPSIP block versus ESPB block in controlling pain after modified radical mastectomy. The primary outcome will be total morphine consumption during the first 24 hours after surgery. Secondary outcomes include pain scores, time to first request for rescue analgesia, hemodynamic stability, recovery profile, patient satisfaction, and postoperative side effects such as nausea and vomiting.

This study aims to determine whether the newer SPSIP block provides comparable or superior pain control to ESPB, with the goal of improving postoperative recovery and reducing opioid requirements in breast cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer represents a major global health burden and remains one of the leading causes of cancer-related mortality among women. Modified radical mastectomy (MRM) is frequently performed as part of surgical management. Despite advances in perioperative care, postoperative pain following MRM remains significant due to extensive tissue dissection involving skin, muscles, and intercostal nerves.

Inadequate postoperative analgesia may result in delayed mobilization, increased opioid consumption, higher incidence of opioid-related adverse effects, prolonged hospital stay, and potential development of chronic post-mastectomy pain syndrome.

Ultrasound-guided fascial plane blocks have gained popularity as part of multimodal analgesia strategies in breast surgery. The erector spinae plane block (ESPB) involves injection of local anesthetic deep to the erector spinae muscle at the thoracic level, allowing spread to dorsal and ventral rami of spinal nerves. ESPB has demonstrated effectiveness in reducing postoperative pain scores and opioid consumption after breast surgery.

The serratus posterior superior intercostal plane (SPSIP) block is a recently described regional anesthesia technique. It involves ultrasound-guided injection of local anesthetic into the fascial plane between the serratus posterior superior muscle and the intercostal muscles, targeting the intercostal nerves. Preliminary reports suggest that SPSIP may provide effective thoracic analgesia with a favorable safety profile.

This prospective randomized clinical trial will include 50 female breast cancer patients undergoing modified radical mastectomy at the National Cancer Institute, Cairo University. Patients will be randomly assigned into two equal groups:

Group SPSIP: Ultrasound-guided serratus posterior superior intercostal plane block.

Group ESPB: Ultrasound-guided erector spinae plane block.

Both blocks will be performed preoperatively under ultrasound guidance using 20 mL of 0.25% bupivacaine. All patients will receive standardized general anesthesia and multimodal analgesia.

The primary outcome measure is total morphine consumption during the first 24 hours postoperatively.

Secondary outcomes include:

Visual Analog Scale (VAS) pain scores at rest and during movement at predefined time intervals (1, 3, 6, 12, 18, and 24 hours)

Time to first request for rescue analgesia

Hemodynamic parameters intraoperatively and postoperatively

Recovery time

Patient satisfaction

Incidence of adverse effects such as nausea and vomiting

The study hypothesis is that SPSIP block provides postoperative analgesia comparable or superior to ESPB in patients undergoing modified radical mastectomy.

The results of this study may contribute to optimizing regional anesthesia strategies for breast cancer surgery and support evidence-based, opioid-sparing perioperative pain management.

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact Backup

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11796

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:

Female patients diagnosed with breast cancer

Scheduled for modified radical mastectomy (MRM)

American Society of Anesthesiologists (ASA) physical status II or III

Age 18-65 years

Body mass index (BMI) > 20 kg/m² and < 35 kg/m²

Ability to understand the study protocol and provide written informed consent

Exclusion Criteria:

Patient refusal to participate

ASA physical status IV or higher

BMI ≤ 20 kg/m² or ≥ 35 kg/m²

Known hypersensitivity or contraindication to local anesthetics, opioids, or study medications

History of chronic pain or regular opioid use

Significant psychiatric disorders affecting pain assessment

Contraindications to regional anesthesia (e.g., infection at injection site, coagulopathy, pre-existing peripheral neuropathy)

Severe respiratory, cardiac, hepatic, or renal disease

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
Experimental: SPSIP Block Group
Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine will be injected into the fascial plane between the serratus posterior superior muscle and the intercostal muscles at the level of the second or third rib. All participants will receive standardized general anesthesia and multimodal postoperative analgesia.
Procedure: Serratus Posterior Superior Intercostal Plane Block
Ultrasound-guided serratus posterior superior intercostal plane block performed preoperatively. A 22G block needle is advanced in-plane under ultrasound guidance to the fascial plane between the serratus posterior superior muscle and the intercostal muscles at the level of the second or third rib. After negative aspiration, 20 mL of 0.25% bupivacaine is injected. The block is performed 30-45 minutes before surgery.
Experimental: ESPB Block Group
Participants will receive an ultrasound-guided erector spinae plane block (ESPB) before induction of general anesthesia. A total of 20 mL of 0.25% bupivacaine will be injected deep to the erector spinae muscle at the T4-T5 transverse process level. All participants will receive standardized general anesthesia and multimodal postoperative analgesia.
Procedure: Erector Spinae Plane Block
Ultrasound-guided erector spinae plane block performed preoperatively. A 22G needle is inserted in-plane to contact the transverse process at the T4-T5 level. After confirmation of correct placement and negative aspiration, 20 mL of 0.25% bupivacaine is injected deep to the erector spinae muscle. The block is performed 30-45 minutes before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total 24-Hour Postoperative Morphine Consumption
Time Frame: First 24 hours postoperatively
Total cumulative dose of intravenous morphine (in milligrams) administered during the first 24 hours after surgery as rescue analgesia. Morphine (3 mg IV) will be administered when the Visual Analogue Scale (VAS) score is ≥ 4. The total amount consumed over 24 hours will be recorded and compared between the two study groups.
First 24 hours postoperatively

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Sayed M Abed, MD, Associate Professor of Anesthesia and Pain Management, National Cancer Institute -- Cairo 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 (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPSIP-ESPB-MRM-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to institutional policies and ethical considerations regarding patient confidentiality. Although all data will be anonymized, sharing individual-level data outside the research team is not permitted under the current Institutional Review Board (IRB) approval. Aggregated results will be available through publication and may be provided upon reasonable request to the corresponding author, in accordance with institutional regulations.

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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