NCT07432256

Brief Summary

This study aims to evaluate the effect of adding a Superficial Parasternal Intercostal Plane Block (PIPB) to the Serratus Anterior Plane Block (SAPB) on postoperative pain control in patients undergoing breast reduction surgery under general anesthesia. Effective postoperative analgesia is essential to reduce opioid consumption and improve recovery. All patients will receive standard general anesthesia. Patients will be allocated into three groups: a control group receiving no regional block, a group receiving SAPB alone, and a group receiving SAPB combined with PIPB. The primary outcome of the study is total opioid consumption within the first 24 hours after surgery. Secondary outcomes include postoperative pain scores, Quality of Recovery-15 (QoR-15) scores, and intraoperative remifentanil consumption. The study aims to determine whether SAPB reduces postoperative opioid requirements compared to no block, and whether adding PIPB provides additional analgesic benefit by blocking the anterior cutaneous branches of the intercostal nerves. The findings may contribute to improving multimodal analgesia strategies in breast surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

February 19, 2026

Last Update Submit

February 19, 2026

Conditions

Keywords

serratus anterior plane blockparasternal intercostal plane blockbreast reduction surgerypain managementpostoperative painQoR-15

Outcome Measures

Primary Outcomes (1)

  • Total postoperative opioid consumption in the first 24 hours

    Total opioid consumption during the first 24 postoperative hours will be recorded and compared between the study groups.

    First 24 hours after surgery

Secondary Outcomes (2)

  • Quality of recovery by using QoR-15 questionnaire

    postoperative 24th hour

  • Pain Scores

    postoperative 0, 1, 2, 6, 12, 24 th hour

Study Arms (3)

control

NO INTERVENTION

patients receive standard general anesthesia

Serratus Anterior Plane Block

ACTIVE COMPARATOR

patients receive an ultrasound guided anterior serratus plane block in addition to general anesthesia before surgery

Procedure: Serratus Anterior Plane Block (SAPB)

Serratus Anterior Plane Block + Parasternal Intercostal Plane Block

ACTIVE COMPARATOR

patients receive an ultrasound guided anterior serratus plane block combined with a parasternal plane block in addition to general anesthesia before surgery

Procedure: Serratus Anterior Plane Block (SAPB) and parasternal intercostal plane block

Interventions

injection local anesthetic between 5th rib and serratus anterior muscle

Serratus Anterior Plane Block

both injection local anesthetic between 5th rib and serratus anterior muscle at midaxillary line and between 4th costal cartilage and pectoralis major muscle at next to the sternum

Serratus Anterior Plane Block + Parasternal Intercostal Plane Block

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients aged 18-65 years
  • Scheduled for elective breast reduction surgery under general anesthesia
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Ability to understand the study and provide written informed consent

You may not qualify if:

  • Patient refusal
  • Known allergy to local anesthetics
  • Coagulopathy or ongoing anticoagulant therapy
  • Infection at the block site
  • Chronic opioid use or opioid dependence
  • Severe hepatic or renal insufficiency
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bulent Ecevit University Hospital

Zonguldak, Maltepe, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

Saposins

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Sphingolipid Activator ProteinsCoenzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 19, 2026

First Posted

February 25, 2026

Study Start

May 1, 2024

Primary Completion

August 25, 2025

Study Completion

December 1, 2025

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations