Ultrasound-guided Transverses Abdominis Plane Block in Inguinal Herniorrhaphy: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Postoperative acute pain measured by the visual analog scale (VAS) from 1-10 with 1 being the lowest and 10 the highest intensity after one hour of anesthesia suspension.
研究概览
简要总结
Acute postoperative pain is one of the most important centers of therapeutic attention in postoperative phase of any procedure. It is a complex entity that requires a multiple intervention to be treated and, depending on the intervened surgical site, it has different approaches.
Despite attempts to reduce postoperative pain by implementing management protocols, rates of pain prevalence from moderate acute to severe pain are still reported as high as 50% in the first 24 postoperative hours. Among the surgeries that report greater intensity of postoperative pain is open inguinal Herniorrhaphy. That is why several techniques have been described for the management of acute pain in this surgery postoperative, among which PAT blocking has shown to be beneficial in some studies. However, some reports question its usefulness but with the emergence of ultrasound-guided techniques for its realization, interest in this blockage has grown back.
This study aims to demonstrate the utility of the PAT blocking in the management of acute pain of pre-peritoneal inguinal herniorrhaphy with mesh.
详细描述
- Patient registry:
The cases will be recorded by an external agent who will verify compliance with the protocol by the treating physicians (surgeons and anesthesiologists); additionally this agent will interview patients for the processing of the instrument and will also collect the proper information of the procedure. At random and in an unannounced way, visits will be made to the centers of attention to verify that the procedure was done according to what had been agreed.
Additionally when the full record of the patients is registered in a database, they will be called one by one to confirm the information collected. Further records are sought in the systematized medical history in order to verify additional information.
a. Quality assurance plan: i. Each record will be completed by an external agent to the surgical procedure who will be trained for this work according to the methodological design of the study.
ii. Regular visits are made to the information collection site to confirm compliance with attention and randomization protocols.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years attending Servicios Especiales de Salud (SES) Hospital of Caldas and Santa Sofia Hospital for inguinal hernia surgery.
- •Physical status classification of the American Society of Anesthesiologists (ASA) (ASA I: healthy patient with no history or comorbidity and ASA II patients with compensated systemic disease).
- •Acceptance to complete the informed consent.
排除标准
- •Bilateral inguinal hernia.
- •Allergy to drugs used in the study protocol (propofol, remifentanil, dipyrone, Dexamethasone, Tramadol, Morphine, Bupivacaine, Cephalexin, Cefazolin, Lidocaine, Sevoflurane, Chlorhexidine, Adrenaline, Naproxen, Acetaminophen)
- •Lack of communication with the patient
- •Inadequate social support network and interaction with the physician.
- •Spinal Anesthesia
- •Herniorrhaphy without mesh.
- •Pregnancy
- •Abuse of psychoactive substances.
- •Daily consumption of opioids.
- •Consumption of analgesics during the last 24 hours prior to surgery.
- •Infection at the incision site
研究组 & 干预措施
TAP block with Bupivacaine at 0.25%
Intervention: Injection of local anesthetics in the transverses abdominal plane
干预措施: TAP block with Bupivacaine at 0.25% (Drug)
Placebo saline solution
Placebo: Injection of saline solution in the transverses abdominal plane
干预措施: Placebo saline solution (Drug)
结局指标
主要结局
Postoperative acute pain measured by the visual analog scale (VAS) from 1-10 with 1 being the lowest and 10 the highest intensity after one hour of anesthesia suspension.
时间窗: 1 hour after the suspension of anesthesia
次要结局
- Opioid Consumption 1(1 hour after the suspension of anesthesia)
- Adverse reactions 1(1 hour after the suspension of anesthesia)
- Postoperative acute pain 2(24 hours after the suspension of anesthesia)
- Adverse reactions 2(24 hours after the suspension of anesthesia)
- Opioid Consumption 2(24 hours after the suspension of anesthesia)
研究者
Patricia Salazar Villegas
Master in Business Administration
Universidad de Caldas