NCT06129383

Brief Summary

the study is a clinical study that will be conducted on women between the ages of 18 and 75 who are scheduled for breast surgery. We aimed to compare the postoperative pain management effect of adding the pecto intercostal fascial plane block to the serratus anterior plane block.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

September 7, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

November 7, 2023

Last Update Submit

November 19, 2023

Conditions

Pain Management

Keywords

Pecto-intercostal facial blockbreast surgery

Outcome Measures

Primary Outcomes (1)

  • Change on analgesic needs of patients in the first 24 hours postoperatively

    Patients' visula pain score should be below 4 within 24 hours post-operatively and the need for analgesia should be reduced or absent.

    within posoparativ 24 hours

Study Arms (2)

Control group to which serratus anterior plane block will be applied

ACTIVE COMPARATOR

Control group patients, accompanied by the 38 mm 6 MHz linear probe of the ultrasound device, , the patient will be placed in the lateral decubitus position and SAP block will be applied to the serratus anterior muscle fascia using 20 ml of 0.25% bupivacaine solution.

Procedure: serratus anterior plane block and pectointercostal plane block in breast surgery

serratus anterior plane block to the pecto intercostal plane block will be applied.

OTHER

SAP block will be applied to the patient's serratus anterior fascia using 20 ml of 0.25% bupivacaine solution. Then, PIFB will be applied to the patient's parasternal region using 10 ml of 0.25% bupivacaine solution.

Procedure: serratus anterior plane block and pectointercostal plane block in breast surgery

Interventions

serratus anterior plane block and pectointercostal plane block in breast surgeryPROCEDURE

Serratus anterior plane block and pecto intercostal plane block will be performed as a single injection using 0.25% bupivacaine and with the same practitioner.

Control group to which serratus anterior plane block will be appliedserratus anterior plane block to the pecto intercostal plane block will be applied.

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients' VA scores should be below 4 within 24 hours post-operatively and the need for analgesia should be reduced or absent.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) class I-III groups,
  • not pregnant or suspected of being pregnant
  • approve the informed consent form will be included in the study.

You may not qualify if:

  • Patients with known local anesthetic allergy or suspected coagulopathy,
  • Infection on injection area
  • Serious neurological disorder
  • Psychiatric disorder
  • Severe cardiovascular disease
  • Liver failure
  • Renal failure
  • Using chronic opioid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ULUDAGU

Bursa, 16110, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Belgin Yavaşçaoglu, prof

    Uludag University Medicine Faculty

    STUDY DIRECTOR

  • SELCAN AKESEN, assoc.prof

    Uludag University Medicine Faculty

    STUDY CHAIR

Central Study Contacts

Özlem Gök

CONTACT

+905469379652ozlmgktp@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Within the scope of this study, two different research groups were identified for which clinical research was planned. The significance level of the power analysis was determined as 0.05 and the power level was determined as 0.80. However, for this study, it was decided to consider the effect size value as 0.4, based on similar studies in the literature. It was deemed sufficient to include n = 26 cases in each group, and it was deemed appropriate to include n = 30 cases in each group, considering a 20% wastage margin. The cases will be divided into 2 groups of 30 people using the sealed envelope method. Group I will include patients who underwent SAP block under general anesthesia (Control group), and Group II will include patients who underwent SAP and PIFB block under general anesthesia (Experimental group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DOCTOR

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 13, 2023

Study Start

September 7, 2023

Primary Completion

February 7, 2024

Study Completion

May 7, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)