Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II

Background and objectives The Pectoral Nerves Block (Pecs) Type II is a regional anesthesia technique that provides post-surgical pain relief for patients undergoing breast surgery. Post-procedural pain relief is known to diminish persistent pain. In this prospective follow-up, the investigators evaluated whether the Pecs II block, compared to placebo, is effective in reducing persistent post-procedural pain after breast cancer surgery in female patients.

Patients and methods 140 breast cancer stage 1-3 patients undergoing mastectomy or tumorectomy with sentinel node or axillary node dissection under general anesthesia were randomized to receive a Pecs block (levobupivacaine 0.25%) or placebo (saline 0.9%). Patients were invited between 9 and 31 months after surgery to complete a persistent postsurgical pain survey.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Post-Procedural Pain Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GZA Sint Augustinus

Wilrijk, Antwerpen, 2610, Belgium

About this study

Breast cancer is the most common cancer in women. For breast cancer patients, surgery is the most effective therapeutic intervention. Up to two thirds of female patients undergoing breast cancer surgery develop chronic post-procedural pain. This can be best understood by the fact that chronic post-procedural pain is strongly associated with acute post-procedural pain and that even minimal breast surgery can result in significant post-procedural pain.

Regional anesthesia techniques can improve acute and chronic post-procedural pain outcomes. In the prospective double blind placebo-controlled randomized controlled trial, the investigators found that the pectoral nerves (Pecs) block type II, as described by Blanco et al., provides reliable and effective post-procedural analgesia for patients undergoing breast surgery.

In this prospective follow-up, the investigators evaluate whether the Pecs II block is effective in reducing chronic post-procedural pain in female adult patients undergoing breast cancer surgery compared to placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

participated in the Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery (NCT02544282)

Exclusion criteria

patient refusal

Treatment and study plan

Chronic pain evaluation

Other

Chronic pain assessment with study questionnaire

Primary outcomes

Chronic post- procedural pain evaluation through questionaire

Time frame: 1-3 years

Evaluation of the chronic post procedural pain in breast surgery under general anesthesia with a pecs or placebo block

Sponsors and collaborators

Lead sponsor

GZA Ziekenhuizen Campus Sint-Augustinus

Other

Registry information

Official study title

Evaluation of Persistent Postsurgical Pain After Breast Surgery With a Pectoral Nerves Block (Pecs) Type II: a Prospective Follow-up After a Prospective Double Blind Placebo-controlled Randomized Controlled Trail

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2018
First posted: Apr 14, 2017
Registry last updated: Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed