Paravertebral Block and Reduction in Opioid Consumption After Mastectomy

This was a prospective, randomized, blinded-assessor study conducted in the Department of Anesthesiology and Intensive Care at the Tunis Maternity and Neonatology Center.

The study included 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. Patients were randomly allocated immediately before entering the operating room into two groups according to a randomization table: Group A received a paravertebral block, while Group B received multimodal analgesia.

In the paravertebral block group, the block was performed under ultrasound guidance on the side of the planned surgery. General anesthesia was then administered according to the study anesthesia protocol.

Postoperative monitoring included close monitoring of vital signs and pain assessment at H0, H6, H12, and H24. Patients were subsequently assessed at three months to identify the presence of chronic postoperative pain and evaluate its severity using the Verbal Rating Scale and the Saint-Antoine Pain Questionnaire.

The primary outcome was intraoperative fentanyl consumption. Secondary outcomes included hypnotic and neuromuscular blocking agent consumption, quality and time to emergence from anesthesia, adverse effects related to the paravertebral block, acute postoperative pain, analgesic consumption, time to ambulation, and chronic pain at three months.

The study protocol included a sample size calculation based on an alpha risk of 5% and a statistical power of 90%. Statistical analysis was performed using SPSS version 20.0. The Chi-square or Fisher's exact test, Student's t-test, and Mann-Whitney U test were used according to the nature of the variables, with the significance threshold set at p < 0.05.

The study was conducted after obtaining approval from the local ethics committee and written informed consent from all participants.

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.