Postoperative PainNCT07401602
Analgesic Strategies After Mastectomy: RIB vs RIB + DPIPB
An observational study of Postoperative Pain, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study evaluates postoperative pain outcomes in patients undergoing elective mastectomy who received systemic analgesia, rhomboid intercostal block (RIB), or combined rhomboid intercostal block with deep parasternal intercostal plane block (RIB + DPIPB). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Analgesic Strategy
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2026to 20 Mar 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult female patients aged 18-70 years who underwent elective mastectomy at a single tertiary care center between October 2024 and October 2025 and had complete postoperative pain and analgesia records available for retrospective analysis.
Who may be able to join
- Female patients aged 18-70 years
- Elective mastectomy performed between October 2024 and October 2025
- ASA physical status I-III
- Complete postoperative pain and analgesia records for the first 24 hours
- Clearly documented analgesic technique (systemic analgesia, RIB, or RIB + DPIPB)
Who cannot join
- Incomplete or missing medical records
- Emergency mastectomy or emergency surgery
- Reoperation within the first 24 hours postoperatively
- Major intraoperative complications preventing standard analgesia
- Neurological or psychiatric conditions interfering with pain assessment
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
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
About this study
Official title: A Retrospective Evaluation of Systemic Analgesia, Rhomboid Intercostal Block, and Combined Rhomboid Intercostal Block With Deep Parasternal Intercostal Plane Block After Mastectomy
This retrospective observational study evaluates postoperative pain outcomes in patients undergoing elective mastectomy who received systemic analgesia, rhomboid intercostal block (RIB), or combined rhomboid intercostal block with deep parasternal intercostal plane block (RIB + DPIPB). Medical records from October 2024 to October 2025 will be reviewed. Primary outcomes include pain scores within the first 24 hours, with secondary outcomes including opioid consumption, additional analgesic requirements, patient satisfaction, and early postoperative complications. All data will be analyzed retrospectively and anonymously.
- Conditions
- Postoperative Pain
- Being tested
- Analgesic Strategy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analgesic StrategyOther
Systemic Analgesia:
Postoperative pain was managed using standard systemic analgesic medications as part of routine clinical care.
Rhomboid Intercostal Block (RIB):
Postoperative analgesia was provided using an ultrasound-guided rhomboid intercostal block performed as part of routine clinical practice.
RIB + Deep Parasternal Intercostal Plane Block (DPIPB):
Postoperative analgesia was provided using a combination of ultrasound-guided rhomboid intercostal block and deep parasternal intercostal plane block as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Systemic Analgesia Group | Not described Receives: Other: Analgesic Strategy | |
| Rhomboid Intercostal Block (RIB) Group | Not described Receives: Other: Analgesic Strategy | |
| RIB + Deep Parasternal Intercostal Plane Block (DPIPB) Group | Not described Receives: Other: Analgesic Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (VAS)
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) based on routinely recorded clinical data.
Measured: Within the first 24 hours after surgery (postoperative 1, 6, 12, and 24 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion10 Mar 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401602
- Sponsor's protocol ID
- zeki mastektomi
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ertas G, Cakmak HS, Ocak S, Yilmaz M, Ozdemir DB, Tulgar S. Is the combination of interfascial plane blocks sufficient for awake breast cancer surgery? An observational, prospective, proof-of-concept study. BMC Anesthesiol. 2024 Sep 20;24(1):337. doi: 10.1186/s12871-024-02725-0.
PubMed 39304815Gu B, Huang ZX, Zhou HD, Lian YH, He S, Ge M, Jiang HF. A Randomized Controlled Trial of Adding Deep Parasternal Intercostal Plane Block to Interpectoral-Pectoserratus Plane Block in Breast Cancer Surgery. Anesth Analg. 2025 May 1;140(5):1188-1194. doi: 10.1213/ANE.0000000000007218.
PubMed 39453840
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Evaluation of Systemic Analgesia, Rhomboid Intercostal Block, and Combined Rhomboid Intercostal Block With Deep Parasternal Intercostal Plane Block After Mastectomy
- ClinicalTrials.gov ID
- NCT07401602
- Acronym / sponsor ID
- zeki mastektomi
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 10 Mar 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 10 Feb 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 retrospective observational study evaluates postoperative pain outcomes in patients undergoing elective mastectomy who received systemic analgesia, rhomboid intercostal block (RIB), or combined rhomboid intercostal block with deep parasternal intercostal plane block (RIB + DPIPB). Medical records from October 2024 to October 2025 will be reviewed. Primary outcomes include pain scores within the first 24 hours, with secondary outcomes including opioid consumption, additional analgesic requirements, patient satisfaction, and early postoperative complications. All data will be analyzed retrospectively and anonymously.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Systemic Analgesia Group | – | Other: Analgesic Strategy |
| Rhomboid Intercostal Block (RIB) Group | – | Other: Analgesic Strategy |
| RIB + Deep Parasternal Intercostal Plane Block (DPIPB) Group | – | Other: Analgesic Strategy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult female patients aged 18-70 years who underwent elective mastectomy at a single tertiary care center between October 2024 and October 2025 and had complete postoperative pain and analgesia records available for retrospective analysis.
Key inclusion criteria (5 listed)
- Female patients aged 18-70 years
- Elective mastectomy performed between October 2024 and October 2025
- ASA physical status I-III
- Complete postoperative pain and analgesia records for the first 24 hours
- Clearly documented analgesic technique (systemic analgesia, RIB, or RIB + DPIPB)
Key exclusion criteria (5 listed)
- Incomplete or missing medical records
- Emergency mastectomy or emergency surgery
- Reoperation within the first 24 hours postoperatively
- Major intraoperative complications preventing standard analgesia
- Neurological or psychiatric conditions interfering with pain assessment
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 |
|---|---|---|
| Analgesic StrategySystemic Analgesia: Postoperative pain was managed using standard systemic analgesic medications as part of routine clinical care. Rhomboid Intercostal Block (RIB): Postoperative analgesia was provided using an ultrasound-guided rhomboid intercostal block performed as part of routine clinical practice. RIB + Deep Parasternal Intercostal Plane Block (DPIPB): Postoperative analgesia was provided using a combination of ultrasound-guided rhomboid intercostal block and deep parasternal intercostal plane block as part of routine clinical care. | Other | RIB + Deep Parasternal Intercostal Plane Block (DPIPB) Group, Rhomboid Intercostal Block (RIB) Group, Systemic Analgesia Group |
Primary outcome
Postoperative Pain Score (VAS)
Time frame: Within the first 24 hours after surgery (postoperative 1, 6, 12, and 24 hours).
Postoperative pain intensity assessed using the Visual Analog Scale (VAS) based on routinely recorded clinical data.
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 10 Feb 2026.
- Results publication: PubMed 39304815Ertas G, Cakmak HS, Ocak S, Yilmaz M, Ozdemir DB, Tulgar S. Is the combination of interfascial plane blocks sufficient for awake breast cancer surgery? An observational, prospective, proof-of-concept study. BMC Anesthesiol. 2024 Sep 20;24(1):337. doi: 10.1186/s12871-024-02725-0.
- Results publication: PubMed 39453840Gu B, Huang ZX, Zhou HD, Lian YH, He S, Ge M, Jiang HF. A Randomized Controlled Trial of Adding Deep Parasternal Intercostal Plane Block to Interpectoral-Pectoserratus Plane Block in Breast Cancer Surgery. Anesth Analg. 2025 May 1;140(5):1188-1194. doi: 10.1213/ANE.0000000000007218.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
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 Istinye 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Feb 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?
Contact Ilke Dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (VAS) (time frame: Within the first 24 hours after surgery (postoperative 1, 6, 12, and 24 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07401602, which also lists 2 linked publications.
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 10 Feb 2026.