EUCTR2019-004039-21-NL进行中（未招募）1 期
Efficacy of Pectoral Nerve (PECS II) Block for Breast Conserving Surgery: A Prospective Randomized Controlled Trial - CONPECSII
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Female gender.
- •- Unilateral breast conserving surgery.
- •- Written informed consent according to ICH/GCP and national regulations.
- •- ASA (American Society of Anesthesiologists) Class I-III .
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
排除标准
- •- Women < 18 year old.
- •- Bilateral surgery.
- •- Bleeding disorder or coagulopathy.
- •- Chest wall deformity or infection of injection site.
- •- Another (additional) nerve block (such as TPVB or epidural anesthesia).
- •- Oncoplastic breast conserving surgery.
- •- Autologous or implant based breast reconstruction.
- •- Known allergy for levobupivacaine or local anesthetics from the amide group.
- •- Chronic use of analgesics / opiates preoperatively (> 12 weeks).
- •- Previous breast surgery ipsi- or contralateral (except diagnostic biopsies).
- •- Not able to speak or understand the Dutch language fluently.
- •- Palliative surgery.
- •- Metastatic disease.
- •- Pregnancy or breast feeding.
- •- Psychological, neurological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol.
- •- Other concurrent solid tumor.
研究者
相似试验
已完成
4 期
Efficacy of Pectoral Nerve (PECS II) Block for Breast Conserving Surgery: A Prospective Randomized Controlled TrialNL-OMON50121Sint Antonius Ziekenhuis200
已完成
4 期
Efficacy of Pectoral Nerve (PECS II) Block for Breast Conserving Surgery: A Prospective Randomized Controlled Trial<p>Breast cancer</p>10006232NL-OMON28887St. Antonius Hospital200
招募中
3 期
Effectiveness of Intra-operative nerve block(PECS-II) with continuous infusion of local anaesthetic drug compared to single dose infiltration of same drug at the end of surgery.CTRI/2018/01/011523Jawaharlal Institute Of Post Graduate Medical Education and Research JIPMER
招募中
3 期
Efficacy of Pectoral Nerve (PECS II) Block with Liposomal Bupivacaine versus Levobupivacaine for Patients undergoing a Mastectomy: A Prospective Randomized Controlled Trial.mammacarcinoma10006291Breast cancerNL-OMON53831Sint Antonius Ziekenhuis130
进行中（未招募）
1 期
PECBLOCK for the Treatment of Pain After Breast SurgeryPainMedDRA version: 18.0 Level: SOC Classification code 10022117 Term: Injury, poisoning and procedural complications System Organ Class: 10022117 - Injury, poisoning and procedural complicationsEUCTR2013-002764-12-FRniversity Hospital, Limoges128