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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Chronic post- procedural pain evaluation through questionaire
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •participated in the Large-scale Prospective Double-blind Randomized Controlled Trial of Pecs II Block for Breast Surgery (NCT02544282)
排除标准
- •patient refusal
研究组 & 干预措施
Pecs group (study group)
Chronic pain assessment with study questionnaire
干预措施: Chronic pain evaluation (Other)
Control group (placebo group)
Chronic pain assessment with study questionnaire
干预措施: Chronic pain evaluation (Other)
结局指标
主要结局
Chronic post- procedural pain evaluation through questionaire
时间窗: 1-3 years
Evaluation of the chronic post procedural pain in breast surgery under general anesthesia with a pecs or placebo block
次要结局
未报告次要终点