Internal, External Intercostal Nerve Block and Intercostal Catheter for Pain Management After Uniportal VATS: a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The effectiveness of the three approaches of pain management after 3 hours of uniportal VATS
研究概览
简要总结
The goal of this clinical trial is to compare the safety and effectiveness of the three intercostal nerve blocks used in pain management in uniportal (one port) thoracoscopic surgeries: internal intercostal nerve blocks (ICNB), external ICNB, and Intercostal catheters.
Participants will be randomly assigned to three groups:
- First group will undergo internal intercostal nerve block
- Second group will be given external intercostal nerve block
- Third group will have an intercostal catheter Researchers will compare the three groups to see their impact on post-operative pain management in uniportal VATS.
详细描述
The main questions this clinical trial aims to answer are:
- To study post-VATS complications, such as: postoperative air leak, post-operative pain, hypoxemia, atelectasis, bleeding, wound infection, pneumonia, Deep Vein Thrombosis, pulmonary embolism and their association with the different approaches of ICNBs.
- To address the cost-effectiveness of the intercostal nerve block approaches.
- To study the participants' level of satisfaction after VATS following each procedure of ICNB.
- To address the relationships between the intercostal nerve block approaches and participants' characteristics such as age, gender, BMI, medical and surgical history, smoking, and alcohol history.
This study is a randomized controlled trial that will take place at Al-Ahli Hospital and Saint Joseph Hospital. The trial will involve 90 participants, who will be randomly assigned to three groups. Of these, group 1 will include 30 participants who'll receive an internal intercostal nerve block, group 2: 30 participants will receive an external intercostal block, and group 3 are the 30 participants who will have an intercostal catheter inserted.
Data will be collected from the participants' themselves through a questionnaire before the surgery. The participants will be followed up after the surgery (3, 6, 24 hours post-operatively) in order to obtain the numerical rating scale. A written informed consent will be sought.
Data Analysis will be done through International Business Machines (IBM) Statistical Package for Social Sciences (SPSS) for Windows Version 16.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The participants will be given the intercostal nerve block/ catheter directly after the completion of their uniportal VATS, and won't be aware which intervention was given to them in order to accurately measure the participants' level of satisfaction
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
- •All participants between the ages of 18 and 80 year-old who have elective or urgent uniportal VATS will be included in the sample.
排除标准
- •Children - under the age of 18 or participants above the age of
- •Participants with chest wall infections and those with decorticated lungs will be excluded from the study.
- •Participants with pre-existing chest pain or severe renal or hepatic dysfunction
- •Participants with a history of psychiatric disorder or inability to understand the consent form or how to use a Numerical Rating Scale (NRS) for pain measurement
- •Participants who have allergy to any of the given drugs, second thoracic surgery, participation in other clinical trials, obesity with body mass index>35 kg/m2, intake of antiplatelet or anticoagulant agents, spinal deformity and severe bradycardia will also be excluded.
- •Participants will be withdrawn from the study if the technical failure happened in the block or VATS procedure was converted to open procedure.
研究组 & 干预措施
External intercostal nerve block
30 participants will be randomised for the External Intercostal block will receive a mixture of analgesics (Marcaine 3mg /kg 0.5%, Lidocaine 2% 10 cc, Dexamethasone 4 mg, 30 cc of Normal Saline (NS) 0.9%, through: Identifying the targeted intercostal spaces: The 3rd-7th by applying digital palpation and indentation of these spaces using the surgeon's fingers and the camera. After identifying the desired spaces, they will use 10 cc syringe connected to 23 Gauge needs, the needle will be applied externally into the chest wall, advancing it with negative pressure, making sure to keep the needle perpendicular to the chest wall to avoid injury to the intercostal neurovascular bundle, advancing the needle while keeping negative pressure, and being closer to the upper border of the ribs. Once the indentation of needle into the pleural is seen, they aspirate again to make sure that they are not into blood vessels, then they will inject 8 cc into each intercostal space.
干预措施: External Intercostal Nerve Block (Other)
Internal intercostal nerve block
30 participants will be randomised for the Internal Intercostal block will receive a mixture of analgesics (the investigators will use a mixture of local analgesics containing: Marcaine 3mg /kg 0.5%, Lidocaine 2% 10 cc, Dexamethasone 4 mg, 30 cc of Normal Saline (NS) 0.9%), through:
-Using the blue color butterfly needle, 23 gauge, The needle will be introduced into the thoracic cavity under the thoracoscopic control and vision, Identification of the intercostal spaces: The third down to the seventh, total of 5 intercostal spaces, the needle will be introduced under vision into the intercostal spaces, avoiding the intercostal artery or veins, aspiration to make sure that they are not into blood vessels, then 10 injecting 8 cc of the analgesic mixture into each of the intercostal spaces, making sure to see the pleura over the intercostal space bulging to indicate that the analgesic is not injected into deeper muscular layers.
干预措施: Internal Intercostal Nerve Block (Other)
Intercostal catheter
30 Participants will be randomised for the Intercostal Catheter, the investigators will use an epidural catheter set, they will apply the catheter to one - two intercostal spaces higher that the VATS incision. The investigators will start by applying the needle from outside, into the desired intercostal space, once they see the indentation of the needle. They will inject 5 - 10 cc of normal saline to distend the intercostal space, then they will remove the stylet part and they will introduce the catheter, after making sure that there is at least 3 centimeter of the catheter into the intercostal space, they will remove the needle, making sure not to move the catheter, then they will tunnel the catheter under the skin for 2 cm , the participant will receive the 15 cc of the previously mentioned mixture every 8 hours for two to three days.
干预措施: Intercostal Catheter (Other)
结局指标
主要结局
The effectiveness of the three approaches of pain management after 3 hours of uniportal VATS
时间窗: From participants enrollment until 3 hours after the surgery
To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS through assessing the pain scores of the participants 3 hours after the surgery using the Numerical rating scale (NRS11). The NRS is a 11-point scale, where "0" represents "no pain", and "10" represents "the most severe pain imaginable" at 3 hours after the uniportal VATS. Points from "1 - 3" means mild pain, "4 - 6" indicates moderate pain, and "7 - 10" indicates severe pain.
The effectiveness of the three approaches of pain management after 6 hours of uniportal VATS
时间窗: From participants enrollment until 6 hours after the surgery
To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS through assessing the pain scores of the participants 6 hours after the surgery using the Numerical rating scale (NRS11). The NRS is a 11-point scale, where "0" represents "no pain", and "10" represents "the most severe pain imaginable" at 6 hours after the uniportal VATS. Points from "1 - 3" means mild pain, "4 - 6" indicates moderate pain, and "7 - 10" indicates severe pain.
The effectiveness of the three approaches of pain management after 24 hours of uniportal VATS
时间窗: From participants enrollment until 24 hours after the surgery
To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS through assessing the pain scores of the participants 24 hours after the surgery using the Numerical rating scale (NRS11). The NRS is a 11-point scale, where "0" represents "no pain", and "10" represents "the most severe pain imaginable" at 24 hours after the uniportal VATS. Points from "1 - 3" means mild pain, "4 - 6" indicates moderate pain, and "7 - 10" indicates severe pain.
The effectiveness of the three approaches of pain management after uniportal VATS
时间窗: From participants enrollment and during the 24 hours post-operatively
To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS through assessing the participants' use of opioids, during the 24 hours post-operatively.
The effectiveness of the three approaches of pain management after uniportal VATS, during different positions
时间窗: 24 hours post-operatively
To Compare the effectiveness of different approaches of intercostal nerve blocks (internal ICNB, external ICNB, Intercostal catheters) for pain management after uniportal VATS, during coughing, deep breathing, lying down, moving and chest tube removal, through the use of NRS11, 24 hours post-operatively. The NRS is a 11-point scale, where "0" represents "no pain", and "10" represents "the most severe pain imaginable" at the three different positions. Points from "1 - 3" means mild pain, "4 - 6" indicates moderate pain, and "7 - 10" indicates severe pain.
次要结局
- The effect of the three different approaches of pain management on post-operative hypoxemia(From participants enrollment until 24 hours after the uniportal VATS)
- The effect of the three different approaches of pain management on post-operative atelectasis(From participants enrollment until 24 hours after the uniportal VATS)
- The effect of the three different approaches of pain management on post-operative Pneumothorax(From participants enrollment until 24 hours after the uniportal VATS)
- Cost-effectiveness of the three approaches(From participants enrollment until the study completion, an average of 7 months)
- Participants' satisfaction level(From participants enrollment until 24 hours after the uniportal VATS)
- The effect of the three different approaches of pain management on post-operative hypoxemia(From participants enrollment until 3 hours after the uniportal VATS)
- The effect of the three different approaches of pain management on post-operative hypoxemia(From participants enrollment until 6 hours after the uniportal VATS)