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临床试验/NCT03901612
NCT03901612撤回4 期

Evaluation of a Peri-Operative Continuous Bilateral Erector Spinae Plane (ESP) Continuous Catheter After Open Cardiac Surgery in Adults

Vinmec Healthcare System1 个研究点 分布在 1 个国家开始时间: 2019年1月5日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
试验地点
1
主要终点
Opioid consumption

研究概览

简要总结

Fast track to Extubation after cardiothoracic surgery is becoming more common after a number of reports showing it is safe and effective. However, It has introduced new challenges to pain control. Intubated patients require larger doses of opioids and benzodiazepines for comfort. In patients who are awake and spontaneously breathing, pain and agitation cannot be treated with lower doses.

Some centers still administer continuous infusions of opioid and benzodiazepines to extubated patients. These infusions may not be necessary and may even be harmful.

The recent pilot study (In press in Journal of cardio thoracic vascular anesthesia ) in our Vinmec hospitals performing open heart surgeries of peri-operative regional analgesia by Continuous Bilateral Erector Spinae Plane Blocks in adult showed that the pain relief was efficient and the requirement for opioids was zero in post-operative period.

It confirmed that the impact of regional anesthesia techniques on main procedure-specific postoperative outcomes is very important in opioids decreased use in the context of fast-track programs that are fully suggested after cardiac surgery.

In April 2017 we introduced the technique of ESP block for open heart surgeries in Adults and in pediatric. At the beginning we performed single shot block and the patients still needed during around 30 to 40 hours small doses of opioids to release their pain according to the evaluation by Comfort-B,FLACC VAS Scales. Since we are performing continuous peri-operative regional analgesia by Bilateral ESP catheters the requirement for additional opioids to release the pain is zero based on our practice of 480 ESP catheters for open heart surgeries.

We would like to compare the 2 analgesic techniques and analyze the post operative opioid consumption, the quality of recovery and the quality of life after the surgery.

详细描述

Methodology With the Approval of Ethical committee of VinMec Healthcare and after Patient's information and consent from guardian or parents, adults will be randomized via a random number generator into one of two treatment groups by the person who obtained consent which is prescribed in the nurse preparation file".

Group 1: will receive a single shot dose of local anesthetic Ropivacaine throw ESP catheters and 6 hours after continuous infusion of Iso saline with a rescue analgesia in case of pain according to the bellow protocol Group 2 :will received a single shot dose of local anesthetic Ropivacaine throw ESP catheters and 6 hours after a continuous infusion of Ropivacaine with a rescue analgesia if needed according to the bellow protocol Catheter Performance The anesthesia team will perform to all patients without exclusion criteria (Group I & II) for open heart surgery after the anesthesia induction a bilateral insertion of an Erector Spinae Plane Block catheter under ultrasound guidance.

Patient in right lateral decubitus. The anesthesiologist will use an Ultrasound linear probe at T4 level and identify the T4 transverse process. By hydro-dissection he will identify the inter-fascial space between the Inter-transverse ligament anteriorly and the Erector Spinae Muscle posteriorly to insert under ultrasound vision a catheter . The tip of the catheter should be at T5 Transverse level seen by ultrasound. The anesthesiologist check the right position of the catheter with a dextrose 5% injection = 1 to 3 mL under ultrasound vision and see the spread of the dextrose in the inter-fascial space which sign that the catheter is not intra-vascular. This procedure will be bilateral. The catheter will have a yellow label on the Huer®-Lock connector to identify clearly that it is regional analgesia catheter to prevent any errors of miss injection. (Yellow is the international identification of regional anesthesia analgesia lines).

After this control an induction low dose is injected. Table 1 Induction dose Patient 30 - 40 kg = 6 mL of Ropivacaine 0.5% / side Patient 40 - 50 kg = 8 mL of Ropivacaine 0.5% / side Patient 50 - 60 kg = 10 mL of Ropivacaine 0.5% / side Patient 60 - 70 kg = 12 mL of Ropivacaine 0.5% / side Patient > 70 kg = 14 mL of Ropivacaine 0.5% / side 5h after, the ESP catheter induction, prepare the solution in the pump The clinical research nurse specially trained for this study will proceed to the randomization of the patient according to the randomization table and prepare the solution in the pump as per attached protocol. They will put the number of patient's randomization on the pump. The nurse receives instruction to keep strictly confidential the content of the pumps. They will deliver the prepared pumps to the anesthesiologist and anesthesia nurse in charge of the patient. They will connect the pumps to the patient and start the infusion 6 hours after as per protocol.

Group 1 & Group 2 will have the blinded solution in the pump ♣ Table 2 Intermittent Automatic bolus For post operative ESP catheter infusion Patient 30 - 40 kg = 6 mL of Ropivacaine 0.5% / side/ 6h Patient 40 - 50 kg = 8 mL of Ropivacaine 0.5% / side/ 6h Patient 50 - 60 kg = 10 mL of Ropivacaine 0.5% / side/ 6h Patient 60 - 70 kg = 12 mL of Ropivacaine 0.5% / side/ 6h Patient > 70 kg = 14 mL of Ropivacaine 0.5% / side/ 6h (The bolus on the second catheter will be delayed by 1 hour).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Solution infused prepared by a different team with a rescue envelop to open in case of incident

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients having an elective open heart surgery

排除标准

  • refusal of the patient allergy to local anesthetics instable patient

研究组 & 干预措施

Saline solution

Placebo Comparator

Post operative analgesia throw the thoracic Erector spinae catheter with saline solution and opioid rescue

干预措施: saline 09% (Drug)

Ropivacaine

Experimental

Post operative analgesia throw the thoracic Erector spinae catheter with Ropivacaine 0.2% solution and opioid rescue

干预措施: Ropivacaine 0.2% (Drug)

结局指标

主要结局

Opioid consumption

时间窗: From extubation to 48 hours after end of surgery

Morphine consumption in milligrams

次要结局

  • Quality of recovery after the surgery(48 hours after end of surgery)
  • Quality of Life after the surgery(30 days after end of surgery)
  • post operative pain(every 6 hours during 48hours after the end of the surgery)

研究者

发起方
Vinmec Healthcare System
申办方类型
Other
责任方
Sponsor

研究点 (1)

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