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Not yet recruiting NCT07302399

Comparison of the Postoperative Analgesic Efficacy of SAP and SPSIP Blocks in Patients Undergoing Mammoplasty

No phase Interventional Postoperative Pain Postsurgical Pain Breast Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Serratus Anterior Plane Block, Serratus Posterior Superior Intercostal Plane Block.
Who it may be relevant to
Registry conditions: Postoperative Pain, Postsurgical Pain, Breast Pain. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

Pain management after breast surgery plays an important role in the patients' recovery process. Therefore, investigating effective and safe analgesic methods is important for improving patient comfort in the postoperative period. The serratus anterior plane block (SAPB) is a regional anesthesia technique commonly used for pain control after breast surgery. SAPB has been shown to be effective in reducing postoperative pain and decreasing opioid consumption. In addition, SAPB is easy to perform and has a low risk of complications. The serratus posterior superior intercostal plane block (SPSIPB) is a new technique developed to provide analgesia in thoracic surgeries. SPSIPB has been reported to be effective in reducing postoperative pain and decreasing analgesic consumption. However, data on the efficacy of SPSIPB in breast surgery are limited. This study aims to compare the postoperative analgesic efficacy of SAPB and SPSIPB in patients undergoing mammoplasty. For this purpose, a double-blind, randomized, controlled trial has been designed.

Interventions

  • Procedure Serratus Anterior Plane Block
    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.
  • Procedure Serratus Posterior Superior Intercostal Plane Block
    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.

Primary outcome measures

  • Total opioid consumption [Time frame: 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. [Time frame: 0, 1, 6, 12 and 24 hours]
Secondary outcome measures (2)
  • Time to first analgesic requirement [Time frame: 24 Hour]
  • Patient satisfaction score [Time frame: 24 Hour]

Eligibility criteria

Inclusion criteria

  • Patients aged 18-85 years
  • Patients undergoing elective mammoplasty
  • ASA physical status I-II

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Turkey (Türkiye) · 1 center
  • Bolu Abant İzzet Baysal Medical School — Bolu

Publications

  • 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 40275145

Identifiers

NCT: NCT07302399 · AIBU-TF-AR-II-005 · AIBU-TF-AR-II-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗