Paravertebral Block and Reduction in Opioid Consumption After Mastectomy
CompletedNot applicableNCT07817797
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Paravertebral Block: Perioperative Opioid-sparing Effect - Acute and Chronic Post-mastectomy Pain.
- Conditions
- Interventions
- Procedure: Paravertebral Block
- Other: Multimodal Analgesia
- Sponsor
- University Tunis El Manar
- Start date
- 2018-01-01
- Primary completion
- 2020-11-02
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Tunisia
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07817797