Postoperative PainNCT06177665
Comparison of Erector Spina Plan Block and Rhomboid Intercostal Block in Breast Surgery
A study testing Erector Spinae Plane Block and Rhomboid Intercostal Block in people with Postoperative Pain and Analgesia, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain, Analgesia
- What is being tested?
- Erector Spinae Plane Block and Rhomboid Intercostal Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Erector Spina Plan Block and Rhomboid Intercostal Block for Postoperative Pain Managment in Patients Undergoing Unilateral Breast Surgery
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.
Read the detailed description
After being informed about the study and potential risks, written consent was obtained from all patients.Patients who meet eligibility requirements will be randomized in a 1:1 ratio to erector spinae plane block and rhomboid intercostal block.
- Conditions
- Postoperative Pain, Analgesia
- Being tested
- Erector Spinae Plane Block, Rhomboid Intercostal Block
- Keywords
- Regional Anesthesia, Erector Spinae Plane Block, Rhomboid Intercostal Block, Breast Surgery
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockOther
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.
Rhomboid Intercostal BlockOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Experimental | 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. Receives: Other: Erector Spinae Plane Block |
| Rhomboid Intercostal Block | Experimental | 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. Receives: Other: Rhomboid Intercostal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphin Consumption
Patients in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia
Measured: during postoperative 24 hours
Secondary outcomes (1)
Numerical Rating Scale(NRS)
A numerical rating scale(NRS) requires the patient to rate their pain on defined scale.For example , 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Measured: during postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start1 Jul 2023
- Primary completion30 Mar 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulnihal Avci, Kocaeli University
- Investigators
- Sevim Cesur Okan, Study director, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177665
- Sponsor's protocol ID
- KAEK/08.bI.02
- Status last verified
- Jul 2024
- First submitted
- 11 Dec 2023
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spina Plan Block and Rhomboid Intercostal Block for Postoperative Pain Managment in Patients Undergoing Unilateral Breast Surgery
- ClinicalTrials.gov ID
- NCT06177665
- Acronym / sponsor ID
- KAEK/08.bI.02
- Conditions
- Postoperative Pain, Analgesia
- Keywords
- Regional Anesthesia, Erector Spinae Plane Block, Rhomboid Intercostal Block, Breast Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
After being informed about the study and potential risks, written consent was obtained from all patients.Patients who meet eligibility requirements will be randomized in a 1:1 ratio to erector spinae plane block and rhomboid intercostal block.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Experimental | Other: Erector Spinae Plane BlockUltrasound(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 | Experimental | Other: Rhomboid Intercostal BlockUltrasound(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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockUltrasound(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. | Other | Erector Spinae Plane Block |
| Rhomboid Intercostal BlockUltrasound(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. | Other | Rhomboid Intercostal Block |
Primary outcome
Morphin Consumption
Time frame: during postoperative 24 hours
Patients in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia
1 secondary outcome
Numerical Rating Scale(NRS)
Time frame: during postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Comparison of rhomboid intercostal nerve block, erector spinae plane block and serratus plane block on analgesia for modified radical mastectomy: A prospective randomised controlled trial.Link provided by the sponsor.
- Rhomboid intercostal blockLink provided by the sponsor.
- Ultrasound-guided fascial plane blocks of the chest wall: a state-of-the-art reviewLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevim Cesur Okan study director
Kocaeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and Rhomboid Intercostal Block in people with Postoperative Pain and Analgesia, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphin Consumption (time frame: during postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.