Effect of Different Volumes of SPSIP Block in Breast Surgery

NCT07783386 | Recruiting

• 2 other identifiers: BSH1626-AKD-46
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

Breast Surgery; Serratus Posterior Superior Intercostal Plane Block; SPSIP Block; Regional Anesthesia; Opioid Consumption; Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Total Postoperative Tramadol Consumption

  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.

  During the first 24 hours after surgery

Secondary Outcomes (2)

• Postoperative Pain Intensity

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

• Quality of Recovery-15 Score

  At 24 hours after surgery

Study Arms (3)

20 mL SPSIP Block Group

EXPERIMENTAL

Participants will receive an ultrasound-guided SPSIP block with 20 mL of 0.25% bupivacaine before general anesthesia.

Drug: Bupivacaine 0.25% (20 mL)

30 mL SPSIP Block Group

EXPERIMENTAL

Participants will receive an ultrasound-guided SPSIP block with 30 mL of 0.25% bupivacaine before general anesthesia.

Drug: Bupivacaine 0.25% (30 mL)

40 mL SPSIP Block Group

EXPERIMENTAL

Participants will receive an ultrasound-guided SPSIP block with 40 mL of 0.25% bupivacaine before general anesthesia.

Drug: Bupivacaine 0.25% (40 mL)

Interventions

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.

20 mL SPSIP Block Group

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.

30 mL SPSIP Block Group

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.

40 mL SPSIP Block Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa City Hospital: lead
• Ulusoy, Emre, M.D.: collaborator

Study Sites (1)

Bursa City Hospital

Nilufer, Bursa, 16110, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

EMRE ULUSOY, MD

CONTACT

05379492799; emreulusoy36@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)