Comparison of Postoperative Analgesic Efficacy of Two Different Blocks in Modified Radical Mastectomy Surgery

NCT07737132 | Not Yet Recruiting

• 1 other identifier: SBU-ANESTEZİ-DMY-06
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

Postoperative pain following modified radical mastectomy remains a significant clinical challenge and may delay recovery, impair patient comfort, and increase opioid consumption. Ultrasound-guided fascial plane blocks have become an important component of multimodal analgesia for breast surgery. The serratus anterior plane block (SAPB) is an established regional anesthesia technique that provides effective postoperative analgesia. The serratus posterior superior intercostal plane block (SPSIPB) is a recently described interfascial block with promising analgesic effects, but evidence comparing its efficacy with SAPB in breast surgery remains limited. This prospective, randomized, double-blind, single-center clinical trial aims to compare the postoperative analgesic efficacy of ultrasound-guided SPSIPB and SAPB in patients undergoing modified radical mastectomy under general anesthesia. Seventy female patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-III will be randomly assigned to receive either SPSIPB or SAPB before surgery. The primary outcome is postoperative pain intensity assessed using the Visual Analog Scale (VAS). Secondary outcomes include intraoperative remifentanil consumption, cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting (PONV), quality of recovery assessed with the QoR-40 questionnaire, rescue analgesic requirements, and block-related complications. The findings of this study are expected to provide evidence regarding the comparative effectiveness and safety of these two interfascial plane blocks for postoperative analgesia in breast cancer surgery.

Conditions

Breast Cancer; Postoperative Pain

Keywords

Modified Radical Mastectomy; Postoperative Pain; Ultrasound-Guided Nerve Block; Serratus Anterior Plane Block; Serratus Posterior Superior Intercostal Plane Block

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity

  Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at predefined postoperative time points.

  24 hours after surgery (assessed at PACU arrival, 30 minutes, 2, 4, and 24 hours postoperatively)

Secondary Outcomes (6)

• Intraoperative remifentanil consumption

  During surgery

• Postoperative tramadol consumption

  24 hours after surgery

• Postoperative nausea and vomiting

  24 hours after surgery

• Quality of recovery

  24 hours after surgery

• Rescue analgesic requirement

  24 hours after surgery

Study Arms (2)

SPSIP Block

EXPERIMENTAL

Participants will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) using 30 mL of 0.25% bupivacaine before induction of general anesthesia. General anesthesia and postoperative analgesic management will be standardized for all participants.

Procedure: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB)

SAP Block

ACTIVE COMPARATOR

Participants will receive an ultrasound-guided Serratus Anterior Plane Block (SAPB) using 30 mL of 0.25% bupivacaine before induction of general anesthesia. General anesthesia and postoperative analgesic management will be standardized for all participants.

Procedure: Ultrasound-Guided Serratus Anterior Plane Block (SAPB)

Interventions

Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block (SPSIPB) PROCEDURE

An ultrasound-guided serratus posterior superior intercostal plane block will be performed before induction of general anesthesia using 30 mL of 0.25% bupivacaine injected into the fascial plane between the serratus posterior superior muscle and the intercostal muscles.

SPSIP Block

Ultrasound-Guided Serratus Anterior Plane Block (SAPB) PROCEDURE

Ultrasound-guided injection of 30 mL of 0.25% bupivacaine into the serratus anterior plane before induction of general anesthesia.

SAP Block

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 aged 18 to 65 years.
• Scheduled for elective modified radical mastectomy under general anesthesia.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Body mass index (BMI) \<35 kg/m².
• Normal coagulation profile (including INR and platelet count).
• Normal liver and renal function tests.
• Able to understand the study procedures and provide written informed consent.

You may not qualify if:

• Known allergy or hypersensitivity to local anesthetics.
• Coagulation disorders or bleeding diathesis.
• Infection or inflammation at the planned block site.
• ASA physical status IV or higher.
• Chronic opioid use or chronic pain requiring long-term analgesic therapy.
• Advanced hepatic or renal insufficiency.
• Severe pulmonary disease.
• Opioid use within 24 hours before surgery.
• Cognitive impairment or inability to complete postoperative assessments.
• Revision breast surgery.
• Refusal to participate in the study.

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Related Publications (3)

• Tang W, Luo G, Lu Y, Chen C, Liu H, Li Y. Application of a new serratus anterior plane block in modified radical mastectomy under ultrasound guidance: A prospective, randomized controlled trial. J Clin Anesth. 2021 Nov;74:110377. doi: 10.1016/j.jclinane.2021.110377. Epub 2021 Jun 9.

  PMID: 34118568 BACKGROUND

• Meng J, Zhao HY, Zhuo XJ, Shen QH. Postoperative Analgesic Effects of Serratus Anterior Plane Block for Thoracic and Breast Surgery: A Meta-analysis of Randomized Controlled Trials. Pain Physician. 2023 Mar;26(2):E51-E62.

  PMID: 36988359 BACKGROUND

• Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Nov;89(11):1054-1056. doi: 10.23736/S0375-9393.23.17432-3. Epub 2023 Jun 1. No abstract available.

  PMID: 37272274 BACKGROUND

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

• Dilek M Yamac

  Sultan Abdülhamid Han education and research hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dilek M Yamac, MD

CONTACT

+905054959792; ddilekmetin@hotmail.com

Dilek M Yamac

CONTACT

05054959792; ddilekmetin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and postoperative outcome assessors will be blinded to treatment allocation. The anesthesiologist performing the block cannot be blinded because of the nature of the intervention and will not participate in postoperative data collection or outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided serratus anterior plane block (SAPB) or serratus posterior superior intercostal plane block (SPSIPB). Outcomes will be compared between the two parallel groups.

Study Record Dates

• First Submitted: July 27, 2026
• First Posted: July 30, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share