NCT06905574

Brief Summary

Surgeon guided serratus block, which can be performed by the surgeon in participants undergoing breast reduction surgery, may reduce the sensation of pain from the surgical field in the postoperative period. Thus, participants experience less pain in the postoperative period, consume less analgesics, and there is a decrease in related complications. The aim of this study was to evaluate the effects of the intraoperative surgeon guided serratus block applied on the analgesic consumption of the participants in the first 24 hours after surgery in participants undergoing breast reduction surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

February 10, 2025

Last Update Submit

January 28, 2026

Conditions

Keywords

breast reductionpostoperative pain control

Outcome Measures

Primary Outcomes (1)

  • 24 hours postoperatively opioid consumption

    In the postoperative period, patients will be given opioids according to their pain density with a patient-controlled device, and the daily Morphine consumption in Patient Controlled Analgesia device will be collected and compared between groups.

    24 hours

Secondary Outcomes (1)

  • post-operative acute pain status, post-operative nausea-vomiting status, post-operative NRS determination of pain at rest and in motion determination of complications such as nausea, vomiting, itching, determination of the first PCA analgesic request.

    24 hours

Study Arms (2)

Group Control

NO INTERVENTION

No intervention will be made in this group.

Group SSPB

EXPERIMENTAL

Surgeon guided serratus block will be applied before closing dermoglandular flaps

Other: surgeon guided serratus block

Interventions

Surgeon guided Serratus Block will be applied before closing dermoglandular flaps

Group SSPB

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient's willingness to be included in the study
  • years
  • Woman
  • Operated with inferior pedicled breast reduction technique
  • The distance from the sternal notch to the nipple complex is between 25-40cm
  • ASA I-II
  • Breast Usg result BIRADS 1-2
  • Patients who have not previously received RT to the breast and have no history of malignancy

You may not qualify if:

  • Patient's request/refusal not to be included in the study
  • Previous history of malignancy
  • RT story,
  • ASA 3-4-5-patient group
  • Severe organ failure
  • Alcohol, drug addiction
  • Bupivacaine allergy
  • Diagnosis of psychiatric illness and psychiatric drug use
  • Surgery lasting longer than 3 hours
  • Bleeding diathesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun training and research hospital

Samsun, 55020, Turkey (Türkiye)

Location

Study Officials

  • Ayhan Sönmez

    SAMSUN UNİVERSİTY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
doctor faculty member

Study Record Dates

First Submitted

February 10, 2025

First Posted

April 1, 2025

Study Start

December 1, 2024

Primary Completion

October 30, 2025

Study Completion

October 31, 2025

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations