SPSIP-RM Study Materials: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Opioid-Sparing Analgesia After Reduction Mammaplasty
收藏资源简介:
This record contains the study materials for the SPSIP-RM trial, a prospective randomized controlled study evaluating the effect of bilateral ultrasound-guided serratus posterior superior intercostal plane block (SPSIP block) on postoperative opioid consumption after elective bilateral reduction mammaplasty. The uploaded package includes the Turkish study protocol, informed consent form, case report/data collection form, master data entry template, field implementation standard operating procedure, randomization plan, and statistical analysis plan. These documents were prepared to support transparent trial conduct, standardized perioperative data collection, reproducibility, and future reporting of the study. Most study documents are provided in Turkish because the trial will be conducted in Türkiye and the materials are intended for local ethics approval, participant consent, and field implementation. An English/Turkish README file is included to describe the contents of the package and to improve accessibility for international readers. No individual participant data are included in this record. The uploaded data template is blank and contains no patient identifiers. The actual allocation sequence, participant identity key, signed consent forms, and any identifiable clinical data will not be shared publicly. ClinicalTrials.gov Identifier: NCT07657949



