Clinical trial · Interventional
Paravertebral Block and Reduction in Opioid Consumption After Mastectomy
Paravertebral Block: Perioperative Opioid-sparing Effect - Acute and Chronic Post-mastectomy Pain.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
This prospective randomized study evaluates the efficacy of paravertebral block in reducing opioid consumption during mastectomy and its impact on acute and chronic postoperative pain. Participants are women over 18 years of age, classified as ASA physical status I or II, with breast cancer and scheduled to undergo unilateral mastectomy with or without axillary lymph node dissection. Participants are randomly assigned to two groups: one receiving a paravertebral block and the other receiving multimodal analgesia. The primary outcome is intraoperative fentanyl consumption. Secondary outcomes include hypnotic and neuromuscular blocking agent consumption, the quality and time to emergence from anesthesia, adverse effects related to the paravertebral block, as well as acute postoperative pain and chronic pain assessed three months after surgery. The study aims to determine whether paravertebral block provides intraoperative opioid-sparing effects and contributes to improved postoperative pain management following mastectomy.
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 |
|---|---|---|---|
| Multimodal Analgesia | Other | — | UNRESOLVED |
| Paravertebral Block | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paravertebral Block
- description
- Participants receive an ultrasound-guided paravertebral block on the operative side before general anesthesia for unilateral mastectomy.
- interventionNames
- Procedure: Paravertebral Block
- type
- EXPERIMENTAL
- label
- Multimodal Analgesia
- description
- Participants receive multimodal analgesia without paravertebral block according to the study protocol.
- interventionNames
- Other: Multimodal Analgesia
Primary outcomes (1)
- measure
- Perioperative fentanyl consumption
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female participants aged more than 18 years. * ASA physical status I or II. * Breast cancer. * Scheduled for unilateral mastectomy with or without axillary lymph node --dissection. * Written informed consent. Exclusion Criteria: * Allergy to local anesthetics and/or level 1 or 2 analgesics. * Contraindication to paravertebral block, including sepsis or coagulation -disorders. * Use of antiarrhythmic drugs. * Long-term analgesic treatment. * Preoperative chemotherapy and/or radiotherapy. * Metastatic or complicated breast cancer. * Thoracic spinal malformations or neuropathy. * History of peptic ulcer disease.
References
Publications (0)
Data not yet available