Comparison of Ultrasound-Guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Postoperative Analgesia Following Thoracotomy Surgeries: a Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- MORPHINE CONSUMPTION
研究概览
简要总结
There are limited studies comparing these two modalities ( thoracic epidural and erector spine block) for relieving the pain after thoracic surgeries .this study aim to investigate this purpose
详细描述
The random sequence will be sealed in consecutively numbered opaque envelopes and kept by the study coordinator. Participants will be randomly divided into two groups according to the 1:1 ratio of ESPB group and TEB group. A research coordinator is designated to distribute and preserve randomization result. The coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug.
The participants will be blinded to the allocation. Because the needle injection of ESPB and TEB are very close, participants themselves could hardly detect the clinical differences. Anaesthesiologists who perform the nerve block and take charge of intraoperative management and surgeons are independent individuals. Only the random sequence number rather than the specific nerve block type will be recorded in the electronic anaesthesia information management system .Researchers who do not take part in the nerve block and intraoperative management are designated to postoperative follow-up. Besides, trained anaesthesiologist who do not perform the block will be designated to evaluate the clinical features of the block objectively
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The random sequence will be sealed in consecutively numbered opaque envelopes and kept by the study coordinator.
Participants will be randomly divided into two groups . The coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug.
The participants will be blinded to the allocation.Anaesthesiologists who perform the nerve block and take charge of intraoperative management and surgeons are independent individuals.Researchers who do not take part in the nerve block and intraoperative management are designated to postoperative follow-up. Besides, trained anaesthesiologist who do not perform the block will be designated to evaluate the clinical features of the block objectively
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients will be from18-70 years old with ( American association of anaesthesiologist) ASA physical status I to III scheduled for elective thoracic surgeries.
排除标准
- •Patients who are:
- •Unable to cooperate.
- •Patients who have allergy to any of the study drugs.
- •Patients who are on opioids.
- •Local infection at the site of injection or systemic infection.
- •Patients with coagulation disorders or on anticoagulation therapy Unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder
- •Unable to perform nerve block procedure due to difficult anatomy through ultrasound scan.
结局指标
主要结局
MORPHINE CONSUMPTION
时间窗: 24 hours
cumulative 24 h opioid (morphine) consumption
Numeric rating scale
时间窗: 24 hours
is an 11-point scale scored from 0-10: 1. "0" = no pain 2. "10" = the most intense pain imaginable Patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours.
次要结局
- Time for first rescue analgesia(24 hours)
- Time to ambulation(24 hours)
- The number of rescue analgesics(24 hours)
- Complications(24 hours)
研究者
Amal Gouda Elsayed Safan
lecturer of anaethesia
Menoufia University