Breast Cancer
Conditions
Keywords
Paravertebral Block, Mastectomy, Perioperative Analgesia, Fentanyl Consumption, Acute Postoperative Pain, Chronic Postoperative Pain, Opioid-Sparing Analgesia
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREParavertebral Block
Ultrasound-guided paravertebral block performed on the operative side before general anesthesia for mastectomy.
OTHERMultimodal Analgesia
Multimodal analgesia consisting of paracetamol and nefopam administered according to the study protocol, with additional postoperative analgesics according to pain intensity.
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors were blinded to treatment allocation. Participants and care providers were not blinded.
Intervention model description
A prospective, randomized, two-parallel-group study comparing a group receiving a paravertebral block with a group receiving multimodal analgesia in patients undergoing unilateral mastectomy with or without axillary lymph node dissection.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative fentanyl consumption | During surgery / perioperative period | Total perioperative fentanyl consumption during surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative hypnotic consumption | During surgery | Amount of hypnotic drugs administered during surgery. |
| Perioperative neuromuscular blocker consumption | During surgery | Amount of neuromuscular blocking agents administered during surgery. |
| Quality of Emergence From General Anesthesia | Perioperative | Quality of emergence from general anesthesia assessed clinically as calm, agitated, or in pain. |
| Time to Emergence From General Anesthesia | Perioperative | Time from completion of the surgical dressing to extubation, measured in minutes. |
| Adverse Events Related to Paravertebral Block | Perioperative/Periprocedural | Incidence of adverse events related to paravertebral block, including systemic local anesthetic toxicity, hematoma, and pneumothorax. |
| Acute Postoperative Pain Assessed Using the Visual Analog Scale | 0, 6, 12, and 24 hours after surgery | Acute postoperative pain assessed using the Visual Analog Scale (VAS). The VAS is a 100-mm horizontal scale ranging from 0 mm (no pain) to 100 mm (worst pain imaginable), with higher scores indicating greater pain intensity. Pain intensity was measured at 0, 6, 12, and 24 hours after surgery. |
| Chronic postoperative pain severity assessed three months after surgery using the Simple Verbal Scale (SVS) | 3 months after surgery | Chronic postoperative pain severity assessed three months after surgery using the Simple Verbal Scale (SVS). The SVS is a 5-point categorical pain scale ranging from 0 (no pain) to 4 (extremely severe pain), with intermediate categories of 1 (mild pain), 2 (moderate pain), and 3 (severe pain). Higher scores indicate greater pain severity. |
| Chronic Postoperative Pain Characteristics Assessed Using the Saint Antoine Pain Questionnaire | 3 months after surgery | Chronic postoperative pain characteristics assessed three months after surgery using the Saint Antoine Pain Questionnaire (QDSA - Questionnaire Douleur Saint Antoine). The QDSA is a validated multidimensional French-language pain questionnaire assessing both sensory and affective dimensions of pain. Each descriptor is rated on a 5-point scale from 0 (absent) to 4 (extremely intense), with higher scores indicating greater pain intensity or unpleasantness. The total score ranges from 0 to 96, with higher scores indicating more severe pain characteristics. |
Countries
Tunisia
Outcome results
None listed