NCT06948383

Brief Summary

The effects of the newly defined serratus posterior superior intercostal plane block and serratus anterior plane block on postoperative analgesia and quality of recovery in women undergoing breast surgery will be investigated.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

April 1, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 15, 2025

Last Update Submit

April 23, 2025

Conditions

Postoperative PainQuality of Recovery

Keywords

postoperative painpain scoresPain managementFasial plane blocks

Outcome Measures

Primary Outcomes (1)

  • postoperative opioid consumption

    total opioid consumption during postoperative 24 hours

    up to 24 hour after surgery

Secondary Outcomes (2)

  • Postoperative pain scores

    postoperative 2nd 6th, 12th 24th hour

  • quality of recovery

    postoperative 24 hour

Study Arms (3)

Group Control

NO INTERVENTION

Group SPSIPB

ACTIVE COMPARATOR
Procedure: Serratus Posterior Superior Intercostal Plane Block

Group SAPB

ACTIVE COMPARATOR
Procedure: Serratus Anterior Plane Block

Interventions

Serratus Posterior Superior Intercostal Plane BlockPROCEDURE

administer 30 mL %0.25 bupivacain between third costa and serratus posterior superior muscle

Group SPSIPB
Serratus Anterior Plane BlockPROCEDURE

administer 30 mL %0.25 bupivacain between 5th costa and serratus anterior muscle in midaxiller line

Group SAPB

Eligibility Criteria

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

You may qualify if:

  • Patients who have received informed consent form Patients who will undergo Breast Cancer Surgery aged between 18-65

You may not qualify if:

  • \<18 years and \>65 years
  • ASA ≥ IV
  • History of allergy to local anesthetics
  • Clinical diagnosis of coagulation disorders
  • Infection near the entry site
  • Chronic analgesic use Patients who will undergo bilateral Breast Cancer Surgery
  • Body mass index \>35
  • Clinical diagnosis of Dementia or confusion
  • Lack of cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

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

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
Principal Investigator

Study Record Dates

First Submitted

April 15, 2025

First Posted

April 29, 2025

Study Start

April 1, 2025

Primary Completion

August 30, 2025

Study Completion

October 1, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)