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COMPLETED
NCT07817797
NA

Paravertebral Block and Reduction in Opioid Consumption After Mastectomy

Sponsor: University Tunis El Manar

View on ClinicalTrials.gov

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

PROCEDURE

Paravertebral Block

Ultrasound-guided paravertebral block performed on the operative side before general anesthesia for mastectomy.

OTHER

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