Comparison of Erector Spina Plan Block and Rhomboid Intercostal Block in Breast Surgery
1 other identifier
interventional
84
1 country
1
Brief Summary
In this study, the investigators compared ultrasound-guided erector spinae plane (ESP) block and rhomboid intercostal block (RIB) on postoperative analgesic effect in unilateral breast surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable postoperative-pain
Started Jul 2023
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
July 1, 2023
CompletedFirst Submitted
Initial submission to the registry
December 11, 2023
CompletedFirst Posted
Study publicly available on registry
December 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedOctober 1, 2025
July 1, 2024
9 months
December 11, 2023
September 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Morphin Consumption
Patients in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia
during postoperative 24 hours
Secondary Outcomes (1)
Numerical Rating Scale(NRS)
during postoperative 24 hours
Study Arms (2)
Erector Spinae Plane Block
EXPERIMENTALUltrasound(US)-guided erector spinae plan block(ESP) with 20 ml 0,25% bupivacaine at T4 vertebra level will performe preoperatively to all patients in the ESP group.
Rhomboid Intercostal Block
EXPERIMENTALUltrasound(US)-guided rhomboid intercostal block(RIB) with 20 ml 0,25% bupivacaine at T5-T6 vertebra level will performe preoperatively to all patients in the RIB group.
Interventions
Ultrasound(US)-guided erector spinae plan block(ESP) with 20 ml 0,25% bupivacaine at T4 vertebra level will performe preoperatively to all patients in the ESP group.
Ultrasound(US)-guided rhomboid intercostal block(RIB) with 20 ml 0,25% bupivacaine at T5-T6 vertebra level will performe preoperatively to all patients in the RIB group.
Eligibility Criteria
You may qualify if:
- Patients who will undergo unilateral breast-conserving surgery (BCS) or modified radical mastectomy (MRM) with or without axillary lymph node dissection
- Patients undergoing elective surgery
- ASA (American Society of Anesthesiologists) physical status classification I-III
You may not qualify if:
- Use of anticoagulants
- Allergy to the medications to be used
- Patients who use analgesic drugs due to a history of chronic pain
- ASA (American Society of Anesthesiologists) physical status classification IV-V
- Patients with psychiatric disorders
- Presence of infection in the area where the block will be applied
- Presence of deformity in the patient's spinal, paraspinal and area where the block will be applied
- The patient does not accept the block application or cannot cooperate with the patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kocaeli University
Kocaeli, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sevim Cesur Okan
Kocaeli University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
December 11, 2023
First Posted
December 20, 2023
Study Start
July 1, 2023
Primary Completion
March 30, 2024
Study Completion
June 1, 2024
Last Updated
October 1, 2025
Record last verified: 2024-07