Clinical trial · Interventional
Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Mastectomy
Mastectomy and Axillary Dissection: Evaluation of the Effect of Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia: A Multicenter, Randomized, Placebo-Controlled Trial
NCT07579650CI-TRIAL-00125054recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aims to evaluate the effect of serratus posterior superior intercostal plane (SPSIP) block on postoperative pain, opioid consumption, and analgesic requirements in patients undergoing mastectomy and axillary lymph node dissection
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SPSIP Block With Bupivacaine | Procedure | — | UNRESOLVED |
| SPSIP Block With Saline | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Serratus Posterior Superior Intercostal Plane Block Group
- description
- Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block prior to surgery using 30 mL of 0.25% bupivacaine, in addition to standard general anesthesia and multimodal analgesia.
- interventionNames
- Procedure: SPSIP Block With Bupivacaine
- type
- PLACEBO_COMPARATOR
- label
- Placebo Group
- description
- Participants in this group will receive an ultrasound-guided placebo block using 30 mL of normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia.
- interventionNames
- Procedure: SPSIP Block With Saline
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged 18-65 years * ASA physical status I-III * Scheduled for elective unilateral mastectomy with axillary lymph node dissection under general anesthesia * Able to understand and use the Numeric Rating Scale (NRS) for pain assessment * Provided written informed consent Exclusion Criteria: * Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine) * Coagulopathy, thrombocytopenia (\<100,000/mm³), or ongoing anticoagulant/antiplatelet therapy that cannot be discontinued * Infection or skin lesion at the injection site * Planned bilateral surgery or additional major surgical procedures * Chronic pain conditions or regular use of opioids, gabapentinoids, or centrally acting analgesics * Neurological or psychiatric conditions interfering with pain assessment * History of previous major thoracic or chest wall surgery on the same side * Pregnancy or breastfeeding * Refusal to participate or inability to provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.