NCT07302399

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

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
7mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress32%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

December 11, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

December 11, 2025

Last Update Submit

January 11, 2026

Conditions

Keywords

MammoplastyPostoperative PainSPSIP BlockSAP Block

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 COMPARATOR

Serratus Anterior Plane Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks for each side.

Procedure: Serratus Anterior Plane Block

SPSIPB Group

EXPERIMENTAL

Serratus Posterior Superior Intercostal Plane Block Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks for each side.

Procedure: Serratus Posterior Superior Intercostal Plane Block

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.

Also known as: SAP Block
SAPB Group

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.

Also known as: SPSIP Block
SPSIPB Group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly females who are planned mammoplasty operation
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Bolu Abant İzzet Baysal Medical School

Bolu, 14030, Turkey (Türkiye)

Location

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

Pain, PostoperativeMastodynia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

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

Locations