NCT07053397

Brief Summary

The aim of this observational study is to compare the analgesic efficacy of continuous infusion via peripheral catheter versus single-shot serratus anterior plane block in women aged 18 to 80 undergoing breast-conserving surgery. The main questions it aims to answer are: Does continuous serratus anterior plane block via peripheral catheter provide superior postoperative analgesic efficacy compared to single-shot serratus anterior plane block? Second question is: Does continuous infusion via catheter in peripheral nerve blocks reduce the amount of intravenous analgesics consumed and improve patient comfort?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

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

January 26, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 26, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 27, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 8, 2025

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

June 27, 2025

Last Update Submit

July 7, 2025

Conditions

Keywords

SAPDeep SAP BlockRegional blockPeripheral blockPeripheral block cathathercontinuous infusion via peripheral block cathather

Outcome Measures

Primary Outcomes (1)

  • Numeric Rating Scale

    1 - 10 1 is minimum pain 10 is maximum pain the lower scale is better for pain management.

    Until discharge after surgery, during an average hospital stay of approximately 24 hours.

Study Arms (2)

SAPB

ACTIVE COMPARATOR

The SAPB arm receives single shot deep serratus anterior plane block before surgery. Also receives iv analgesic treatment after post-operative duration.

Procedure: Serratus Anterior Plane Block (SAPB) group

DSAPB

EXPERIMENTAL

The DSAPB arm receives deep serratus anterior plane block and cathather replacement before surgery. After surgery, the arm takes continous analgesic treatment via periferic block cathather.

Procedure: Serratus Anterior Plane Block (SAPB) groupProcedure: DSAPB

Interventions

The SAP block, which is among the chest wall blocks, provides its effect by blocking the lateral cutaneous branches of the T2-T9 intercostal nerves, n. intercostobrachial , n. longus thoracicus , n. thoracodorsal. SAP block can be performed in two ways: superficial and deep. The deep SAP block is administered between the serratus anterior and intercostal muscles, at the intersection point of the anterior axillary line and the level of the nipple (at the level of the 4th-5th ribs). It has a wide range of use for postoperative pain management in trauma surgery, cardiac surgery, thoracic surgery and breast surgery.

Also known as: serratus anterior plane block
DSAPBSAPB
DSAPBPROCEDURE

The SAP block, which is among the chest wall blocks, provides its effect by blocking the lateral cutaneous branches of the T2-T9 intercostal nerves, n. intercostobrachial , n. longus thoracicus , n. thoracodorsal. SAP block can be performed in two ways: superficial and deep. The deep SAP block is administered between the serratus anterior and intercostal muscles, at the intersection point of the anterior axillary line and the level of the nipple (at the level of the 4th-5th ribs). Following hydrodissection between the serratus anterior and intercostal muscles, a single-shot injection is administered. Subsequently, a peripheral nerve block catheter is placed in the same region under ultrasound guidance.

Also known as: serratus anterior plane peripheral block cathather replacement
DSAPB

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients aged 18 to 80 years
  • Scheduled for breast-conserving surgery
  • Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III

You may not qualify if:

  • Patients with coagulopathy
  • Patients with wounds or infections at the block site
  • Patients with known allergy to local anesthetic agents
  • Patients with mental retardation or limited cooperation
  • Patients who do not consent to participate in the study
  • Patients who, for any reason, discontinue participation during the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi

Istanbul, Kadıköy, 34722, Turkey (Türkiye)

Location

MeSH Terms

Interventions

SaposinsPopulation Groups

Intervention Hierarchy (Ancestors)

Sphingolipid Activator ProteinsCoenzymesEnzymes and CoenzymesDemographyPopulation Characteristics

Study Design

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

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 8, 2025

Study Start

January 26, 2025

Primary Completion

April 26, 2025

Study Completion

May 26, 2025

Last Updated

July 10, 2025

Record last verified: 2025-07

Locations