Clinical Research Directory
Browse clinical research sites, groups, and studies.
Paravertebral Block and Reduction in Opioid Consumption After Mastectomy
Sponsor: University Tunis El Manar
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.
Official title: Paravertebral Block: Perioperative Opioid-sparing Effect - Acute and Chronic Post-mastectomy Pain.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2018-01-01
Completion Date
2020-12-20
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Paravertebral Block
Ultrasound-guided paravertebral block performed on the operative side before general anesthesia for mastectomy.
Multimodal Analgesia
Multimodal analgesia consisting of paracetamol and nefopam administered according to the study protocol, with additional postoperative analgesics according to pain intensity.
Locations (1)
Centre de Maternité et de Néonatologie de Tunis (CMNT)
Tunis, Tunisia