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Clinical Trials/NCT07302399
NCT07302399
Not yet recruiting
Not Applicable

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

Abant Izzet Baysal University1 site in 1 country60 target enrollmentStarted: February 1, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
Total opioid consumption

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Participant, Outcomes Assessor)

Masking Description

Double

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts 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

Arms & Interventions

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.

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.

Outcomes

Primary Outcomes

Total opioid consumption

Time Frame: 0, 1, 6, 12 and 24 hours

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.

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

Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 1, 6, 12 and 24 hours.

Secondary Outcomes

  • Time to first analgesic requirement(24 Hour)
  • Patient satisfaction score(24 Hour)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ilker Ital

Ass. Prof. Dr

Abant Izzet Baysal University

Study Sites (1)

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