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NCT Number: NCT07783386

Effect of Different Volumes of SPSIP Block in Breast Surgery

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bursa City Hospital

Nilufer, Bursa, 16110, Turkey (Türkiye)

Location status: Recruiting

Location contact

emre ulusoy

CONTACT

[email protected]

05379492799

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine 0.25% (20 mL)

Drug

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)

Drug

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)

Drug

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.

Primary outcomes

  1. Total Postoperative Tramadol Consumption

    Time frame: 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.

Secondary outcomes

  1. Postoperative Pain Intensity

    Time frame: At 0, 2, 4, 8, 16, and 24 hours after surgery

    Pain intensity will be assessed using the 11-point Numerical Rating Scale, ranging from 0 (no pain) to 10 (worst imaginable pain). Static pain will be evaluated at rest. Dynamic pain will be evaluated during 30-60 degrees of arm abduction on the operated side and during deep inspiration. Higher scores indicate greater pain intensity.

  2. Quality of Recovery-15 Score

    Time frame: At 24 hours after surgery

    Postoperative quality of recovery will be assessed using the Quality of Recovery-15 questionnaire. The total score ranges from 0 to 150, with higher scores indicating better postoperative recovery.

Study contacts

Contact information is provided by the study sponsor or research team.

EMRE ULUSOY, MD

CONTACT

[email protected]

05379492799

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Collaborators

  • Ulusoy, Emre, M.D.

Registry information

Official study title

Effectiveness of Serratus Posterior Superior Intercostal Plane Block Administered With Different Volumes of 0.25% Bupivacaine for Postoperative Analgesia in Breast Surgery: A Prospective, Randomized, Double-Blind Study

Acronym: SPSIP-VOLUME

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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