Comparison of the Postoperative Analgesic Efficacy of SAP and SPSIP Blocks in Patients Undergoing Mammoplasty
SPSIP
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim is to compare the postoperative analgesic efficacy of serratus anterior plane block (SAPB) and serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing mammoplasty surgery. To this end, a double-blind, randomized, controlled study has been designed. Female patients aged 18-65 years who will undergo mammoplasty surgery will be included in the study. Postoperative pain levels, opioid consumption, duration of analgesic requirement, and patient satisfaction will be evaluated in patients who receive fascial blocks for analgesic purposes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable postoperative-pain
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2025
CompletedFirst Posted
Study publicly available on registry
December 24, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 13, 2026
January 1, 2026
10 months
December 11, 2025
January 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total opioid consumption
Tramadol will be prepared at a concentration of 10 mg/mL, and patient-controlled analgesia (PCA) will be administered without a basal infusion, using a lock-out interval of 20 minutes and a bolus dose of 20 mg.
0, 1, 6, 12 and 24 hours
Postoperative pain scores (Numerical rating scale: NRS),Between 0 and 10 points (11 points in total), as the score increases, the pain intensity increases.
Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 1, 6, 12 and 24 hours.
0, 1, 6, 12 and 24 hours
Secondary Outcomes (2)
Time to first analgesic requirement
24 Hour
Patient satisfaction score
24 Hour
Study Arms (2)
SAPB Group
ACTIVE COMPARATORSerratus Anterior Plane Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks for each side.
SPSIPB Group
EXPERIMENTALSerratus Posterior Superior Intercostal Plane Block Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks for each side.
Interventions
Application of ultrasound-guided serratus anterior plane block for perioperative analgesia for mammoplasty operations. Serratus anterior plane block will be administered under general anesthesia before the surgery Drug: Bupivacaine (Block Drug) For block performances, 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc) for each side.
Application of ultrasound-guided serratus anterior plane block for perioperative analgesia for mammoplasty operations. Serratus posterior superior intercostal plane block will be administered under general anesthesia before the surgery Drug: Bupivacaine (Block Drug) For block performances, 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc) for each side.
Eligibility Criteria
You may qualify if:
- Patients aged 18-85 years
- Patients undergoing elective mammoplasty
- ASA physical status I-II
You may not qualify if:
- Patients who refuse to participate
- Mentally disabled patients
- Presence of infection at the injection site
- Patients with coagulopathy
- History of allergy or toxicity to local anesthetics
- Patients with uncontrolled hypertension
- Patients with uncontrolled diabetes mellitus
- Patients with hepatic or renal failure
- Pregnant, breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Çam Sakura Şehir Hastanesicollaborator
- Istanbul Medipol University Hospitalcollaborator
- Abant Izzet Baysal Universitylead
- Karabuk Training and Research Hospitalcollaborator
Study Sites (1)
Bolu Abant İzzet Baysal Medical School
Bolu, 14030, Turkey (Türkiye)
Related Publications (1)
Koksal BG, Baytar C, Bayraktar E, Balbaloglu H. Effects of serratus posterior superior intercostal plane block on postoperative analgesia in patients undergoing breast cancer surgery: a randomized controlled trial. BMC Anesthesiol. 2025 Apr 24;25(1):209. doi: 10.1186/s12871-025-03092-0.
PMID: 40275145BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Double
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass. Prof. Dr
Study Record Dates
First Submitted
December 11, 2025
First Posted
December 24, 2025
Study Start
February 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 13, 2026
Record last verified: 2026-01