Post-Operative Pain Control After Aortic EndoaneurYsmEctomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative pain evaluation
研究概览
简要总结
Open abdominal aortic aneurysm repair (OR-AAA) is an operation associated with high morbidity, and has 30-day mortality rates of between 4 and 14%. Post-operative pain management represents a primary anesthetic focus.
A better analgesia, in addition to being desirable for the patient, can potentially reduce complications associated with postoperative pain and ensure faster functional recovery.
The modern concept of multimodal analgesia involves the association of multiple drugs and/or analgesic techniques to maximize the quality of analgesia and reduce the side effects of the individual methods. In this context, the addition of epidural analgesia (EA) to the intravenous administration of "traditional" analgesic drugs has assumed the role of gold standard in many surgeries, including OR-AAA.
Over time, EA has proven to be a better analgesic technique than the use of intravenous opioids alone, however there is much uncertainty regarding its ability to reduce complications, morbidity and mortality of patients.
For some time, efforts to research effective, less invasive and safe anesthetic alternatives, have been directed towards the development of multimodal analgesia protocols with the aim of reducing complications and ensuring faster recovery. New approaches to post-operative pain management are emerging, including rectus sheat block (RSB).
Currently there is no evidence regarding the effectiveness of RSB in pain control after OR-AAA.
In this context, the study aims to compare two different post-operative pain management protocols, with the aim of verifying whether the use of RSB can guarantee a non-inferior level of analgesia with reduction of complications compared to AE.
详细描述
This is a prospective, randomized controlled, single-centre, non-profit, spontaneous study, which involves the evaluation of the control of post-operative pain in a population of adult patients admitted to the General Intensive Care Unit after elective open endoaneurysmectomy of the abdominal aorta.
The study will be conducted by analyzing two groups of patients, randomized to receive ether postoperative analgesia via epidural catheter (EA Group) or repeated blocks of the rectus fascia (RSB Group).
Pre- and intra-operative management In EA Group the epidural catheter will be positioned, according to the normal practices of the Operating Unit, before the operation. The insertion of the catheter will be carried out at the T10-T12 level for a maximum of 5-7 cm in the epidural space.
For both groups under study, the operation will be conducted under balanced general anesthesia, using a volatile anesthetic (Desflurane or Sevoflurane) associated with Remifentanil, with titratable doses in order to guarantee an adequate depth of anesthesia, understood as bispectral index (BIS ) between 40 and 60. Myoresolution will be maintained with the use of neuromuscular monitoring (TOF, Train Of Four).
After intubation, the bladder catheter, nasogastric tube, central venous catheter (with ultrasound-guided technique) will be positioned and the following will be prepared:
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
- Single (Participant)
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
- •adult patients (age > 18 years)
- •patients who have given their consent to participate in the study
- •patients undergoing elective "open" surgical treatment of an abdominal aortic aneurysm with a midline xipho-pubic incision.
排除标准
- •Pregnant women
- •Patients being treated for chronic pain
- •Known allergy to drugs included in analgesia protocols
- •Contraindications to the use of one of the two methods provided:
- •refusal by the patient
- •infection at the puncture site
- •coagulopathy:
- •PTT > 40 s and/or INR > 1.4
- •platelet count < 50,000/µL
- •taking antiplatelet or anticoagulant drugs that have not been discontinued in good time, according to international guidelines
- •Emergent intervention
- •Lack of consent to participate in the study
研究组 & 干预措施
EA
Patients of EA Group will receive analgesia via epidural catheter (Ropivacaine 0.15% with double initial bolus and subsequent continuous infusion 5 ml/h via elastomeric pump)
干预措施: Postoperative pain control (Procedure)
RSB
In patients in the RSB Group, repeated blocks of the abdominal wall will be performed using special catheters positioned bilaterally in the rectus muscle fascia using ultrasound guidance (Ropivacaine 0.375% 20 ml per side, administered every 12 hours: at T0, T12 and T24)
干预措施: Postoperative pain control (Procedure)
结局指标
主要结局
Postoperative pain evaluation
时间窗: day 0 (12 h after extubation)
Postoperative pain will be evaluated using Numerical Rating Scale (NRS) (from 0 to 10, where 0 indicates no pain and 10 is the worst pain ever had)
次要结局
- Opioids consumption(within 36 hours from extubation)
- Complications associated to postoperative analgesia(within 36 hours from extubation)
研究者
Daniela Mazzaccaro
Co-Investigator, Vascular Surgeon
IRCCS Policlinico S. Donato