NCT07401602

Brief 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). 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2026

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2026

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

28 days

First QC Date

February 3, 2026

Last Update Submit

February 3, 2026

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Score (VAS)

    Postoperative pain intensity assessed using the Visual Analog Scale (VAS) based on routinely recorded clinical data.

    Within the first 24 hours after surgery (postoperative 1, 6, 12, and 24 hours).

Study Arms (3)

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

Interventions

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.

RIB + Deep Parasternal Intercostal Plane Block (DPIPB) GroupRhomboid Intercostal Block (RIB) GroupSystemic Analgesia Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 39304815RESULT

  • Gu 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.

    PMID: 39453840RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Ilke Dolgun

CONTACT

+905555485632ilkeser2004@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

February 10, 2026

Primary Completion

March 10, 2026

Study Completion

March 20, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations

TU(1)