Postoperative Analgesic Effectiveness of Fascial Plane Blocks in Breast Surgery
Investigation of the Postoperative Effectiveness of Fascial Plane Blocks Used for Analgesia in Patients Undergoing Breast Surgery: A Prospective Observational Study
1 other identifier
observational
90
1 country
1
Brief Summary
This prospective, single-center observational study will compare postoperative pain control in adults undergoing elective breast surgery. Ninety participants will be evaluated in three groups based on routine clinical care: rhomboid intercostal plane block, serratus posterior superior intercostal plane block, and control. The anesthesia method and fascial plane block will be selected by the treating anesthesiologist, and the research team will not assign participants to a group. The main outcome is the total amount of tramadol used through patient-controlled analgesia during the first 24 hours after surgery. Pain scores at rest and during movement, sensory block levels, postoperative nausea and vomiting, and block-related complications will also be recorded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2026
Shorter than P25 for all trials
1 active site
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 1, 2026
CompletedFirst Submitted
Initial submission to the registry
September 15, 2026
CompletedFirst Posted
Study publicly available on registry
September 21, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
September 23, 2026
September 1, 2026
11 months
September 15, 2026
September 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative Tramadol Consumption During the First 24 Hours After Surgery
The total amount of tramadol consumed through the patient-controlled analgesia device will be recorded in milligrams at postoperative hour 24.
During the first 24 postoperative hours
Secondary Outcomes (5)
Numeric Rating Scale Pain Score at Rest
At postoperative hours 0, 2, 4, 6, 12, and 24
Numeric Rating Scale Pain Score During Movement
At postoperative hours 0, 2, 4, 6, 12, and 24
Dermatomal Extent of Sensory Block Assessed by Pinprick
At postoperative hours 0, 2, 4, 6, 12, and 24
Incidence of Postoperative Nausea and Vomiting
During the first 24 postoperative hours
Incidence of Block-Related Complications
During the first 24 postoperative hours
Study Arms (3)
Rhomboid Intercostal Plane Block Group
Participants undergoing elective breast surgery who receive a rhomboid intercostal plane block as selected by the treating anesthesiologist during routine clinical care. The local anesthetic type and dose used for the block will be recorded.
Serratus Posterior Superior Intercostal Plane Block Group
Participants undergoing elective breast surgery who receive a serratus posterior superior intercostal plane block as selected by the treating anesthesiologist during routine clinical care. The local anesthetic type and dose used for the block will be recorded.
Control Group
Participants undergoing elective breast surgery who are included in the control cohort as determined by routine clinical care. Investigators do not assign participants to this cohort and perform postoperative follow-up only.Participants managed with intravenous patient-controlled analgesia as selected by the responsible anesthesiologist during routine clinical care.
Interventions
Participants managed with intravenous patient-controlled analgesia as selected by the responsible anesthesiologist during routine clinical care.
A fascial plane block in which local anesthetic is injected into the plane between the rhomboid major and intercostal muscles. The treating anesthesiologist selects the technique as part of routine clinical care, and the type and dose of local anesthetic used are recorded.
A fascial plane block in which local anesthetic is injected into the plane between the serratus posterior superior and intercostal muscles. The treating anesthesiologist selects the technique as part of routine clinical care, and the type and dose of local anesthetic used are recorded.
Eligibility Criteria
Participants aged 18 to 80 years who are scheduled for elective breast surgery under general anesthesia at the single study center, provide written informed consent, and meet all eligibility criteria.
You may qualify if:
- Age 18 to 80 years
- American society of anesthesiologists physical status I to III
- Undergoing surgery under general anesthesia
- Provision of written informed consent
- Scheduled for elective breast surgery
You may not qualify if:
- History of allergy to local anesthetic medications
- Coagulation disorder
- Body mass index greater than 40 kg/m2
- Infection at the block application site
- Chronic pain syndrome
- Pregnancy
- Inability to communicate
- Requirement for emergency surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology and Reanimation
Study Record Dates
First Submitted
September 15, 2026
First Posted
September 21, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
February 25, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
September 23, 2026
Record last verified: 2026-09