Effects of Transverse Abdominis Plane Block Guided by Ultrasound on the Postoperative Analgesia and Quality of Lives Among the Patients Undergo Inguinal Hernia Repair
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- chronic post-surgical pain
研究概览
简要总结
The incidence of post-operative pain after open inguinal hernia repair is high and impair the quality of lives of the patients.The purpose of this study is to determine whether transverse abdominis plane block combined with intravenous patient controlled analgesia is superior to intravenous patient controlled analgesia in improving the quality of life and reducing the incidence of chronic post-surgical pain
详细描述
The incidence of post-operative pain after open inguinal hernia repair is high according to a a larger-sample epidemic research. Meanwhile, the investigators also found the incidence of CPSP of herniorrhaphy was 37.8% among the patients with PCA, and the incidence of neuropathic pain was 37.5% in these patients with CPSP. European hernia society has proposed that local infiltration anesthesia was suggested to all patients without any contraindications who undergo inguinal hernia repair. Transverse abdominis plane block(TABP),which injecting local anesthetics into the interval between obliquus internus abdominis muscle and transverse abdominal muscle could block the abdominal nerve and could alleviate the pain postoperatively. TABP can block the two mainly nerve (iliohypogastric nerve, ilioinguinal nerve) for inguinal hernia repair and so it seems to have a good effects to relieve the pain of inguinal hernia repair. So the investigators conduct the randomized controlled trial to investigate whether transversus abdominis plane block combined with intravenous patient controlled analgesia is superior to intravenous patient controlled analgesia in improving the quality of life and reducing the incidence of chronic post-surgical pain.
This study was approved by the Medical Ethics Committee of the First Affiliated Hospital of Chongqing Medical University. All potentially eligible participants will be asked to give written informed consent before they are enrolled in this study. This study is a prospective, randomized, controlled clinical trial guided by the standard of good clinical practice (GCP), and eligible participants are divided into two groups: group TAPB and group PCIA, and assess the outcomes of the incidence of acute and chronic postoperative pain and the effects of the two methods on the quality of lives of patients undergo inguinal hernia repair.
Participants in group TAPB will receive transversus abdominis plane block guided by ultrasound at the end of the surgery and also receive intravenous patient controlled analgesia after surgery.
Participants in group PCIA will only receive intravenous patient controlled analgesia after surgery.
The primary outcome of the study is VAS scores at rest and in motion at 3 months postoperatively. The secondary outcomes of this study are chronic post-surgical pain at 6 and 12 months postoperatively, acute post-operative pain, rescue medication and the incidence of neuropathic pain at 3, 6,12 months postoperatively, also the quality of life measured by EQ-5D questionnaire, adverse events associated with postoperative analgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of inguinal hernia and will receive open inguinal hernia repair (UHS mesh)
- •men or woman and 18 ~ 80 years old
排除标准
- •body mass index≤18 or≥35
- •American Society of Anesthesiology (ASA) classification of anesthesia risk IV and V grade
- •allergic to local anesthetics
- •hepatic or renal failure
- •being pregnant
- •skin infection at the puncture site
- •pre-operative opioid or non-steroidal anti-inflammatory drugs treatment for chronic pain
- •addicted to drugs or alcohol
- •uncontrolled general infection
- •femoral hernia, incisional hernia or other special types of hernia
结局指标
主要结局
chronic post-surgical pain
时间窗: 3 months postoperatively
chronic post-surgical pain will be measured by visual analogue scale (VAS)
次要结局
- quality of life(3,6,12 months postoperatively)
- The incidence of neuropathic pain(3,6,12 months postoperatively)
- moderate-severe pain(3,6,12 months postoperatively)
- chronic post-surgical pain(6 and 12 months postoperatively)
- analgesia rescue(post-operative day 1 to 3)
- adverse events(post-operative day 1 to 3)
- acute post-operative pain(24h, 48h postoperatively and at discharging time)
研究者
Min Su
The Department of Anestheiology and Pain Medicine
First Affiliated Hospital of Chongqing Medical University