NCT07246720

Brief Summary

This prospective, randomized clinical study aims to compare the analgesic efficacy of the interpectoral-pectoserratus plane block and the serratus posterior superior intercostal plane block for postoperative pain management in patients undergoing breast cancer surgery. Both techniques are ultrasound-guided regional anesthesia methods targeting different interfascial planes of the thoracic wall. The study will evaluate postoperative pain scores, opioid consumption, Quality of recovery and potential complications. The findings are expected to contribute to optimizing regional anesthesia strategies for enhanced recovery and improved analgesia following breast cancer surgery.

Trial Health

63
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Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress68%
Nov 2025Jun 2026

Study Start

First participant enrolled

November 15, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

7 months

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

Interpectoral-Pectoserratus Plane BlockSerratus Posterior Superior Intercostal Plane BlockBreast Cancer SurgeryOpioid ConsumptionPain Management

Outcome Measures

Primary Outcomes (1)

  • Cumulative opioid consumption

    Cumulative opioid consumption in the first 24 postoperative hours after the completion of the surgical procedure

    in the first 24 hours after completion of the surgical procedure

Secondary Outcomes (2)

  • Postsurgical Quality of Recovery measured by the Quality of Recovery questionnaire

    first day after surgery

  • Number of episodes of postoperative pain

    In the first 24 hours after completion of the surgical procedure

Study Arms (2)

Group IPP-PSP

ACTIVE COMPARATOR

Interpectoral-Pectoserratus Plane Block

Procedure: Interpectoral-Pectoserratus Plane Block

Group SPSIPB

ACTIVE COMPARATOR

Serratus Posterior Superior Intercostal Plane Block

Procedure: Serratus Posterior Superior Intercostal Plane Block

Interventions

Ultrasound-guided injection between pectoralis major-minor and pectoralis minor-serratus anterior planes.

Group IPP-PSP

Ultrasound-guided injection between the serratus posterior superior muscle and the intercostal muscles.

Group SPSIPB

Eligibility Criteria

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

You may qualify if:

  • years of age
  • ASA I-II-III risk groups
  • Patients with informed consent
  • Patients undergoing breast cancer surgery

You may not qualify if:

  • ASA ≥ IV
  • History of allergy to local anesthetics
  • Known coagulation disorders
  • Infection near the insertion site
  • Chronic analgesic use
  • Patients with diabetes mellitus and those receiving neoadjuvant chemotherapy (due to potential impairment of pain sensation)
  • Body mass index \>30
  • Dementia or confusion
  • Lack of cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguladk Bulent ecevit University

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeBreast NeoplasmsAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Central Study Contacts

çağdaş baytar, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

November 15, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations