NCT06862752

Brief Summary

the aim of the study compare the analgesic effect of erector spinae block and serratus anterior block in breast surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

March 1, 2025

Last Update Submit

February 13, 2026

Conditions

Keywords

post operative painopioid consumptionerector spinae blockserratus anterior plane block

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Tramadol consumption in Patient Controlled Analgesia device postoperative 24 hours.

    24 hour

Secondary Outcomes (5)

  • Pain assessed by NRS

    24 hour

  • Rate of opioid related side effects

    24 hour

  • Blooad loss

    during surgery

  • Remifentanil consumption

    during surgery

  • Length of stay in hospital

    30 days

Study Arms (2)

ESP block group

ACTIVE COMPARATOR

Bilateral ultrasound guided erector spine plane (ESP) block will be performe preoperatively at T5 level. 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL serum physiologic % l) will be injected deep to the erector spinae muscle

Procedure: erector spine plane (ESP) block

SAP Block grup

OTHER

Bilateral ultrasound guided serratus plane block with 20 ml %0,25 bupivacaine at the midaxillary 5. Rib

Procedure: Serratus Anterior Plane Block

Interventions

Bilateral ultrasound guided erector spine plane (ESP) block will be performe preoperatively at T5 level. 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL serum physiologic % l) will be injected deep to the erector spinae muscle.

ESP block group

Bilateral ultrasound guided serratus plane block with 20 ml %0,25 bupivacaine at the midaxillary 5. Rib

SAP Block grup

Eligibility Criteria

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

You may qualify if:

  • American Society of Anesthesiologists (ASA) I-II,
  • years of age, adult,
  • female patients
  • undergoing elective breast reduction surgery

You may not qualify if:

  • Allergy to amide-type local anesthetics
  • Infection at the block injection site
  • Severe obesity (BMI \> 35 kg/m2)
  • Liver or renal deficiency
  • Patients with anatomical deformities
  • Recent use of analgesic drugs
  • Patient refusal or inability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sisli etfal research and training hospital

Istanbul, 34371, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeOpioid-Related Disorders

Interventions

ParapsychologyDental Occlusion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and ActivitiesDentistryDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • AYSE SURHAN CINAR

    SISLI HAMIDIYE ETFAL RESEARCH AND TRAINING

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

March 1, 2025

First Posted

March 6, 2025

Study Start

April 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 15, 2026

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations