Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Mastectomy

NCT07579650 | Recruiting

• 1 other identifier: 27/01/2026-38
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effect of serratus posterior superior intercostal plane (SPSIP) block on postoperative pain, opioid consumption, and analgesic requirements in patients undergoing mastectomy and axillary lymph node dissection

Conditions

Breast Cancer

Keywords

mastectomy

Outcome Measures

Primary Outcomes (1)

• 24-hour cumulative opioid consumption

  Total opioid consumption within the first 24 hours after surgery, recorded in milligrams.

  24 hours

Secondary Outcomes (7)

• Static postoperative pain intensity at rest

  0, 1, 2, 6, 12, and 24 hours after surgery

• Dynamic postoperative pain intensity during movement

  0, 1, 2, 6, 12, and 24 hours after surgery

• Rescue analgesia requirement

  Within 24 hours after surgery

• Time to first rescue analgesia

  Within 24 hours after surgery

• Incidence of postoperative nausea and vomiting (PONV)

  Within 24 hours after surgery

Study Arms (2)

Serratus Posterior Superior Intercostal Plane Block Group

EXPERIMENTAL

Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block prior to surgery using 30 mL of 0.25% bupivacaine, in addition to standard general anesthesia and multimodal analgesia.

Procedure: SPSIP Block With Bupivacaine

Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive an ultrasound-guided placebo block using 30 mL of normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia.

Procedure: SPSIP Block With Saline

Interventions

SPSIP Block With Bupivacaine PROCEDURE

Participants will receive an ultrasound-guided SPSIP block using bupivacaine.

Serratus Posterior Superior Intercostal Plane Block Group

SPSIP Block With Saline PROCEDURE

Participants will receive an ultrasound-guided SPSIP block using normal saline under identical conditions.

Placebo 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 aged 18-65 years
• ASA physical status I-III
• Scheduled for elective unilateral mastectomy with axillary lymph node dissection under general anesthesia
• Able to understand and use the Numeric Rating Scale (NRS) for pain assessment
• Provided written informed consent

You may not qualify if:

• Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)
• Coagulopathy, thrombocytopenia (\<100,000/mm³), or ongoing anticoagulant/antiplatelet therapy that cannot be discontinued
• Infection or skin lesion at the injection site
• Planned bilateral surgery or additional major surgical procedures
• Chronic pain conditions or regular use of opioids, gabapentinoids, or centrally acting analgesics
• Neurological or psychiatric conditions interfering with pain assessment
• History of previous major thoracic or chest wall surgery on the same side
• Pregnancy or breastfeeding
• Refusal to participate or inability to provide informed consent

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Fatma Acil

Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Fatma Acil, M.D.

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Acil, M.D.

CONTACT

+905337225225; acilfatma@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Study solutions (local anesthetic or saline) will be prepared by an independent anesthesiologist not involved in patient care or data collection. Syringes will be identical in appearance, volume, and labeling. Randomization assignments will be concealed using sealed opaque envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the SPSIP block group or the placebo group using a computer-generated randomization sequence. Both groups will receive identical perioperative management, and outcomes will be compared between parallel groups.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 12, 2026
• Study Start: May 16, 2026
• Primary Completion (Estimated): June 29, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Time Frame: "Starting 6 months and ending 36 months following article publication
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to : acilfatma@gmail.com

Locations

TU (1)