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Recruiting Not applicable

Effect of Different Volumes of SPSIP Block in Breast Surgery

NCT07783386 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-03-15
Last updated
2026-08-24

Condition(s) studied

Postoperative Pain

Investigational drug(s) / intervention(s)

Bupivacaine 0.25% (20 mL) →Bupivacaine 0.25% (30 mL) →Bupivacaine 0.25% (40 mL) →

Bupivacaine 0.25% (20 mL): A single ultrasound-guided serratus posterior superior intercostal plane block will be performed before general anesthesia using 20 mL of 0.25% bupivacaine. The local anesthetic will be injected between the serratus posterior superior and intercostal muscles at the T3-T4 level.

Bupivacaine 0.25% (30 mL): A single ultrasound-guided serratus posterior superior intercostal plane block will be performed before general anesthesia using 30 mL of 0.25% bupivacaine. The local anesthetic will be injected between the serratus posterior superior and intercostal muscles at the T3-T4 level.

Bupivacaine 0.25% (40 mL): A single ultrasound-guided serratus posterior superior intercostal plane block will be performed before general anesthesia using 40 mL of 0.25% bupivacaine. The local anesthetic will be injected between the serratus posterior superior and intercostal muscles at the T3-T4 level.

Study summary

This randomized, double-blind study will compare the effectiveness of three different volumes of serratus posterior superior intercostal plane block for postoperative pain control in patients undergoing unilateral breast surgery with axillary lymph node dissection. Ninety participants will be randomly assigned to receive 20 mL, 30 mL, or 40 mL of 0.25% bupivacaine.

The primary outcome is total tramadol consumption during the first 24 hours after surgery. Pain scores, time to first analgesic request, rescue analgesic use, quality of recovery, postoperative nausea and vomiting, block success, and block-related complications will also be evaluated.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Aged 18 to 75 years * American Society of Anesthesiologists physical status I-III * Scheduled for elective unilateral breast surgery under general anesthesia * Able to provide written informed consent Exclusion Criteria: * Refusal to participate * Coagulopathy * Known allergy to local anesthetics or a history of local anesthetic systemic toxicity * Liver or kidney failure * Uncontrolled diabetes mellitus * Uncontrolled hypertension * Cognitive impairment or inability to understand the study procedures * Chronic pain requiring opioid therapy * Current antidepressant use * Neuropathic pain * Infection at the block injection site * Pregnancy, suspected pregnancy, or breastfeeding * Clinically significant frailty

Primary outcome measure(s)

  • Total Postoperative Tramadol Consumption — During the first 24 hours after surgery
    Cumulative tramadol consumption delivered through patient-controlled analgesia will be recorded in milligrams and compared among the 20 mL, 30 mL, and 40 mL SPSIP block groups. Higher values indicate greater opioid consumption.

Trial sites (1)

FacilityCityRegionStatus
Bursa City Hospital Nilufer Bursa Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07783386 on ClinicalTrials.gov ↗ ← All trials in Turkey