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

NCT07446868 | Recruiting

• 1 other identifier: SPSIP-ESPB-MRM-2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Postoperative Pain; Acute Post-surgical Pain

Keywords

Erector Spinae Plane Block; Modified Radical Mastectomy; Serratus Posterior Superior Intercostal Plane Block

Outcome Measures

Primary Outcomes (1)

• Total 24-Hour Postoperative Morphine Consumption

  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

Study Arms (2)

SPSIP Block Group

EXPERIMENTAL

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

ESPB Block Group

EXPERIMENTAL

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

Interventions

Serratus Posterior Superior Intercostal Plane Block PROCEDURE

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.

SPSIP Block Group

Erector Spinae Plane Block PROCEDURE

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.

ESPB Block Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National Cancer Institute - Cairo University

Cairo, Cairo Governorate, 11796, Egypt

RECRUITING

Related Publications (2)

• Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.

  PMID: 36883093 RESULT

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sayed M Abed, MD

  Associate Professor of Anesthesia and Pain Management, National Cancer Institute -- Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sayed M Abed, MD

CONTACT

+20 122 680 6532; sayed.abed@nci.cu.edu.eg

Sara F Ali, MSc

CONTACT

+20 111588521; Sarafarghaly1234@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to group allocation. Postoperative pain assessment and data collection will be performed by investigators who are unaware of group assignment. The anesthesiologist performing the block cannot be blinded due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block or ultrasound-guided erector spinae plane block (ESPB) prior to modified radical mastectomy. Both groups will receive standardized general anesthesia and multimodal analgesia. Outcomes will be compared between groups during the first 24 postoperative hours.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)