Clinical trial · Interventional
Single vs Multiple Injection Intertransverse Process Block in Breast Cancer Surgery
Comparison of Single-Injection and Multiple-Injection Intertransverse Process Block for Postoperative Analgesia in Breast Cancer Surgery: A Randomized Controlled Trial
- 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 randomized clinical trial aims to evaluate and compare the analgesic efficacy of single Intertransverse Process Block (ITP) and multiple Intertransverse Process Block (ITP) in patients undergoing Breast Cancer Surgery. The primary outcome is Visual Analog Scale (VAS) during the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block performance time, block-related and systemic side effects (hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, infection), Patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire.
Conditions
Conditions (5)
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 |
| Intertransverse Process Block | — | UNRESOLVED | — |
| Mastectomy | — | UNRESOLVED | — |
| Postoperative Pain | — | UNRESOLVED | — |
| Regional Anaesthesia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiple Level Intertransverse Process Block | Procedure | — | UNRESOLVED |
| Single Level Intertransverse Process Block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Single Level Intertransverse Process Block
- interventionNames
- Procedure: Single Level Intertransverse Process Block
- type
- ACTIVE_COMPARATOR
- label
- Multiple Level Intertransverse Process Block
- interventionNames
- Procedure: Multiple Level Intertransverse Process Block
Primary outcomes (1)
- measure
- postoperative pain intensity (VAS score)
- timeFrame
- 0, 1, 4, 8, 12, and 24 hours after surgery
- description
- Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. Measurements will be recorded at predefined time points within the first 24 hours after surgery.
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 breast cancer surgery * Body mass index (BMI) between 18 and 35 kg/m² * Ability to understand and use the patient-controlled analgesia (PCA) device * Ability to provide written informed consent Exclusion Criteria: * Refusal to participate * Allergy to local anesthetics * Infection at the injection site * Coagulopathy or ongoing anticoagulant therapy * Chronic opioid use or opioid dependence * Severe hepatic or renal insufficiency * Pregnancy or breastfeeding * Cognitive impairment or inability to communicate pain scores * Body mass index (BMI) \<18 or \>35 kg/m²
References
Publications (0)
Data not yet available