Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery

Pain, Postoperative Clinical Trial

Official title: Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery: Effect on Postoperative Pain and Opioid Consumption

Status Completed

Clinical Trial Summary

In this prospective trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to general anesthesia with opioids combined with a Pecs II block or to general anesthesia with opioids combined with a placebo Pecs II block. Participants will be followed postoperatively during their entire hospital stay to determine the effectiveness of Pecs II block and opioids versus placebo Pecs II block and opioids as postoperative pain treatment.

Clinical Trial Description

Each year, 9400 new cases of breast cancer are diagnosed in Belgium. It makes breast cancer the most common cancer in women, good for more than one third of all cancer cases in women.

Surgical excision of the tumour is a necessary and effective step to cure from the disease. Recent studies have demonstrated the positive effects of regional anesthesia on peroperative and postoperative pain. Paravertebral blocks have become popular as an alternative to the analgesia provided by the 'gold standard' of thoracic epidural analgesia. However, both regional techniques have complications and slow learning curves that make them unsuitable for the large proportion of breast surgery patients who are treated on a day-stay basis. Recently, Rafael Blanco introduced the Pecs and Pecs II blocks, a practical alternative to both paravertebral and epidural blockade in the management of pain after breast surgery.

The investigators introduced the Pecs II block in their clinical practice. This study compares general anesthesia with a Pecs II block to general anesthesia with a placebo Pecs II block for breast surgery. The objective is to evaluate analgesic effectiveness and changes in opioid consumption when applying a Pecs II block versus a placebo Pecs II block.

Stage 1-3 patients having mastectomies or tumourectomies with axillary clearance will be randomly assigned to general anesthesia with a Pecs II block or to general anesthesia with a placebo Pecs II block. Enrolling 140 patients over an anticipated time frame of 2 years will provide an 90% power and a p-value of 0.05 for perioperative and postoperative opioid consumption as well as pain scores (NRS). Confirming the hypothesis will indicate that a minor modification to the anesthetic procedure will reduce the opioid consumption (including it's unwanted side effects) during and after surgery while maintaining or reducing patients' indicated pain scores (NRS). ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

• NCT number: NCT02544282
• Study type: Interventional
• Source: GZA Ziekenhuizen Campus Sint-Augustinus
• Status: Completed
• Phase: Phase 4
• Start date: April 2014
• Completion date: March 2016