Paravertebral Block and Reduction in Opioid Consumption After Mastectomy

NCT07817797 | Completed

• 1 other identifier: BPV-MAST-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Paravertebral Block; Mastectomy; Perioperative Analgesia; Fentanyl Consumption; Acute Postoperative Pain; Chronic Postoperative Pain; Opioid-Sparing Analgesia

Outcome Measures

Primary Outcomes (1)

• Perioperative fentanyl consumption

  Total perioperative fentanyl consumption during surgery.

  During surgery / perioperative period

Secondary Outcomes (8)

• Perioperative hypnotic consumption

  During surgery

• Perioperative neuromuscular blocker consumption

  During surgery

• Quality of Emergence From General Anesthesia

  Perioperative

• Time to Emergence From General Anesthesia

  Perioperative

• Adverse Events Related to Paravertebral Block

  Perioperative/Periprocedural

Study Arms (2)

Paravertebral Block

EXPERIMENTAL

Participants receive an ultrasound-guided paravertebral block on the operative side before general anesthesia for unilateral mastectomy.

Procedure: Paravertebral Block

Multimodal Analgesia

EXPERIMENTAL

Participants receive multimodal analgesia without paravertebral block according to the study protocol.

Other: Multimodal Analgesia

Interventions

Paravertebral Block PROCEDURE

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

Paravertebral Block

Multimodal Analgesia OTHER

Multimodal analgesia consisting of paracetamol and nefopam administered according to the study protocol, with additional postoperative analgesics according to pain intensity.

Multimodal Analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Centre de Maternité et de Néonatologie de Tunis (CMNT)

Tunis, Tunisia

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors were blinded to treatment allocation. Participants and care providers were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 14, 2026
• Study Start: January 1, 2018
• Primary Completion: November 2, 2020
• Study Completion: December 20, 2020
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)