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

NCT ID: NCT07302399

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-12-01

Brief Summary

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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

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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.

Conditions

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Postoperative Pain Postsurgical Pain Breast Pain

Keywords

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Mammoplasty Postoperative Pain SPSIP Block SAP Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Double

Study Groups

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SAPB Group

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

Group Type ACTIVE_COMPARATOR

Serratus Anterior Plane Block

Intervention Type PROCEDURE

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.

SPSIPB Group

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

Group Type EXPERIMENTAL

Serratus Posterior Superior Intercostal Plane Block

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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SAP Block SPSIP Block

Eligibility Criteria

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Inclusion Criteria

Patients aged 18-85 years with ASA physical status I-II undergoing elective mammoplasty surgery.

Exclusion Criteria

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

Patients receiving chronic pain therapy (opioid use)

Patients who use of antidepressant medication

Presence of neuropathic pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karabuk Training and Research Hospital

OTHER

Sponsor Role collaborator

Çam Sakura Şehir Hastanesi

UNKNOWN

Sponsor Role collaborator

Istanbul Medipol University Hospital

OTHER

Sponsor Role collaborator

Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Ilker Ital

Ass. Prof. Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bolu Abant İzzet Baysal Medical School

Bolu, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Kasım İlker İtal

Role: CONTACT

Phone: +90 5337723300

Email: [email protected]

Kenan Kart

Role: CONTACT

Phone: +90 5386606553

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 40275145 (View on PubMed)

Other Identifiers

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AIBU-TF-AR-II-005

Identifier Type: REGISTRY

Identifier Source: secondary_id

AIBU-TF-AR-II-005

Identifier Type: -

Identifier Source: org_study_id