Postoperative PainNCT07830446
Postoperative Analgesic Effectiveness of Fascial Plane Blocks in Breast Surgery
An observational study of Postoperative Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Rhomboid intercostal plane block and Serratus posterior superior intercostal plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa
Korgün Ökmen, +90 505 708 10 21, korgunokmen@gmail.com
About this study
Official title: Investigation of the Postoperative Effectiveness of Fascial Plane Blocks Used for Analgesia in Patients Undergoing Breast Surgery: A Prospective Observational Study
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.
Read the detailed description
Patients aged 18 to 80 years who are scheduled for elective breast surgery under general anesthesia and meet the eligibility criteria will be enrolled after providing written informed consent. Group classification will reflect the regional analgesia approach selected as part of routine care by the treating anesthesiologist. The investigators will not participate in the selection of the anesthesia method, the fascial plane block, or the study group.
The study will include 90 participants in three observational cohorts: rhomboid intercostal plane block, serratus posterior superior intercostal plane block, and control. The primary outcome is cumulative tramadol consumption recorded by patient-controlled analgesia during the first 24 postoperative hours. Secondary assessments include Numeric Rating Scale pain scores at rest and during movement at postoperative hours 0, 2, 4, 6, 12, and 24; sensory block level assessed by pinprick testing in the block groups; postoperative nausea and vomiting; and block-related complications.
- Conditions
- Postoperative Pain
- Being tested
- Rhomboid intercostal plane block, Serratus posterior superior intercostal plane block, Control Group
- Keywords
- Breast Surgery, Postoperative Analgesia, Fascial Plane Block, Regional Anesthesia, Rhomboid Intercostal Plane Block, Serratus Posterior Superior Intercostal Plane Block, Patient-Controlled Analgesia, Numeric Rating Scale, Tramadol
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid intercostal plane blockProcedure or surgery
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.
Serratus posterior superior intercostal plane blockProcedure or surgery
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.
Control GroupProcedure or surgery
Participants managed with intravenous patient-controlled analgesia as selected by the responsible anesthesiologist during routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Rhomboid intercostal plane block; Procedure: Control Group | |
| 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. Receives: Procedure: Serratus posterior superior intercostal plane block; Procedure: Control Group | |
| 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. Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the first 24 postoperative hours
Secondary outcomes (5)
Numeric Rating Scale Pain Score at Rest
Pain intensity at rest will be assessed using a Numeric Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain.
Measured: At postoperative hours 0, 2, 4, 6, 12, and 24
Numeric Rating Scale Pain Score During Movement
Pain intensity during movement, including coughing or deep breathing, will be assessed using a Numeric Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain.
Measured: At postoperative hours 0, 2, 4, 6, 12, and 24
Dermatomal Extent of Sensory Block Assessed by Pinprick
Among participants in the block groups, sensory block will be assessed by pinprick, and the upper and lower dermatomal boundaries will be recorded.
Measured: At postoperative hours 0, 2, 4, 6, 12, and 24
Incidence of Postoperative Nausea and Vomiting
The occurrence of postoperative nausea and vomiting will be recorded for each participant.
Measured: During the first 24 postoperative hours
Incidence of Block-Related Complications
Block-related complications will be recorded among participants in the block groups.
Measured: During the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Apr 2026
- Primary completion25 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830446
- Sponsor's protocol ID
- BYIEAH-FPB-2026-01
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Sep 2026
- 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Postoperative Effectiveness of Fascial Plane Blocks Used for Analgesia in Patients Undergoing Breast Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07830446
- Acronym / sponsor ID
- BYIEAH-FPB-2026-01
- Conditions
- Postoperative Pain
- Keywords
- Breast Surgery, Postoperative Analgesia, Fascial Plane Block, Regional Anesthesia, Rhomboid Intercostal Plane Block, Serratus Posterior Superior Intercostal Plane Block, Patient-Controlled Analgesia, Numeric Rating Scale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 21 Sep 2026 (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.
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.
Detailed description
Patients aged 18 to 80 years who are scheduled for elective breast surgery under general anesthesia and meet the eligibility criteria will be enrolled after providing written informed consent. Group classification will reflect the regional analgesia approach selected as part of routine care by the treating anesthesiologist. The investigators will not participate in the selection of the anesthesia method, the fascial plane block, or the study group.
The study will include 90 participants in three observational cohorts: rhomboid intercostal plane block, serratus posterior superior intercostal plane block, and control. The primary outcome is cumulative tramadol consumption recorded by patient-controlled analgesia during the first 24 postoperative hours. Secondary assessments include Numeric Rating Scale pain scores at rest and during movement at postoperative hours 0, 2, 4, 6, 12, and 24; sensory block level assessed by pinprick testing in the block groups; postoperative nausea and vomiting; and block-related complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rhomboid Intercostal Plane Block Group | – | Procedure: Rhomboid intercostal plane block, Procedure: Control GroupParticipants 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 | – | Procedure: Serratus posterior superior intercostal plane block, Procedure: Control GroupParticipants 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 | – | Procedure: Control GroupParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Rhomboid intercostal plane blockA 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. | Procedure or surgery | Rhomboid Intercostal Plane Block Group |
| Serratus posterior superior intercostal plane blockA 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. | Procedure or surgery | Serratus Posterior Superior Intercostal Plane Block Group |
| Control GroupParticipants managed with intravenous patient-controlled analgesia as selected by the responsible anesthesiologist during routine clinical care. | Procedure or surgery | Control Group, Rhomboid Intercostal Plane Block Group, Serratus Posterior Superior Intercostal Plane Block Group |
Primary outcome
Cumulative Tramadol Consumption During the First 24 Hours After Surgery
Time frame: During the first 24 postoperative hours
The total amount of tramadol consumed through the patient-controlled analgesia device will be recorded in milligrams at postoperative hour 24.
5 secondary outcomes
Numeric Rating Scale Pain Score at Rest
Time frame: At postoperative hours 0, 2, 4, 6, 12, and 24
Numeric Rating Scale Pain Score During Movement
Time frame: At postoperative hours 0, 2, 4, 6, 12, and 24
Dermatomal Extent of Sensory Block Assessed by Pinprick
Time frame: At postoperative hours 0, 2, 4, 6, 12, and 24
Incidence of Postoperative Nausea and Vomiting
Time frame: During the first 24 postoperative hours
Incidence of Block-Related Complications
Time frame: During the first 24 postoperative hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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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.
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Bursa Yuksek Ihtisas Training and Research Hospital 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 5 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Tramadol Consumption During the First 24 Hours After Surgery (time frame: During the first 24 postoperative 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 23 Sep 2026.