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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07302399
Acronym
SPSIP
Enrollment
60
Registered
2025-12-24
Start date
2026-02-01
Completion date
2026-12-01
Last updated
2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Pain, Postoperative Pain, Postsurgical Pain

Keywords

Mammoplasty, Postoperative Pain, SPSIP Block, SAP Block

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.

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

PROCEDURESerratus 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.

PROCEDURESerratus 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.

Sponsors

Karabuk Training and Research Hospital
CollaboratorOTHER
Çam Sakura Şehir Hastanesi
CollaboratorUNKNOWN
Istanbul Medipol University Hospital
CollaboratorOTHER
Abant Izzet Baysal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Total opioid consumption0, 1, 6, 12 and 24 hoursTramadol 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.
Postoperative pain scores (Numerical rating scale: NRS),Between 0 and 10 points (11 points in total), as the score increases, the pain intensity increases.0, 1, 6, 12 and 24 hoursPostoperative 24 hours period. Patients' pain scores will be questioned at 0, 1, 6, 12 and 24 hours.

Secondary

MeasureTime frameDescription
Time to first analgesic requirement24 HourTime from end of surgery to first analgesic requirement (min)
Patient satisfaction score24 HourOverall patient satisfaction scores will be assessed using a 5-point Likert scale,Minimum value: 1, Maximum value: 5, where higher scores indicate greater satisfaction.

Countries

Turkey (Türkiye)

Contacts

Primary ContactKasım İlker İtal
ilkerital@gmail.com+90 5337723300
Backup ContactKenan Kart
kenankart@karabuk.edu.tr+90 5386606553

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026