NCT07056413

Brief Summary

Regional analgesia technique in addition to multimodal analgesia in breast-conserving surgery aims to reduce opioid consumption. This study evaluates the postoperative analgesic efficacy of ultrasound-guided BRILMA block in patients undergoing breast conserving surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable postoperative-pain

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

Study Start

First participant enrolled

April 22, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 9, 2025

Completed
Last Updated

July 9, 2025

Status Verified

June 1, 2025

Enrollment Period

1 year

First QC Date

June 30, 2025

Last Update Submit

July 8, 2025

Conditions

Keywords

BRILMA blockbreast-conserving surgery

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    Amount of morphine consumption

    postoperative 24-hour

Secondary Outcomes (8)

  • Static and dynamic pain scores assessed with numeric rating scale

    postoperative 24 hours

  • number of blocked dermatome

    20. minute after block performance

  • Duration of block application

    up to 15 minutes

  • Amount of fentanyl for sedation. [Time Frame: Intraoperative 2-3 hours]

    during surgery

  • Rescue analgesia

    postoperative 24 hours

  • +3 more secondary outcomes

Study Arms (2)

Group B: BRILMA block

EXPERIMENTAL

20 ml 0.25 % bupivacaine was injected into the fascial plane between the serratus anterior muscle and the external intercostal muscle at T4 level.

Procedure: BRILMA block

Group C: Control

OTHER

Standard intravenous analgesia.

Other: Standard intravenous analgesia.

Interventions

BRILMA blockPROCEDURE

20 ml 0.25 % bupivacaine was injected into the fascial plane between the serratus anterior muscle and the external intercostal muscle at T4 level.

Group B: BRILMA block

Standard intravenous analgesia.

Group C: Control

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast-conserving surgery
  • ASA I-III

You may not qualify if:

  • Patient refusal
  • Presence of contraindications for regional anesthesia ( bleeding disorder, infection at the injection site, local anesthetic allergy)
  • Chronic analgesic use
  • Preoperative breast pain
  • BMI \>35

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Nükhet Sivrikoz, Assoc. Prof. Dr.

    Attending anesthesiologist

    PRINCIPAL INVESTIGATOR

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
Attending Anesthesiologist

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 9, 2025

Study Start

April 22, 2024

Primary Completion

May 5, 2025

Study Completion

May 5, 2025

Last Updated

July 9, 2025

Record last verified: 2025-06

Locations