Perioperative Haemostasis, Procedure-Related Pain After Physiological or Pharmacological Modifications of Local Anaesthesia Around the Eyes (P4LE)
2026年7月30日 更新者：Wu Chun Long、Prince of Wales Hospital, Shatin, Hong Kong
Perioperative Haemostasis, Procedure-Related Pain After Physiological or Pharmacological Modifications of Local Anaesthesia Around the Eyes (P4LE) - a Double-Masked, Split-Face, Active-Controlled, Pilot Randomised Clinical Trial
The goal of this clinical trial is to determine whether buffering, warming, or addition of hyaluronidase or tranexamic acid to lignocaine during eyelid injection of local anaesthesia reduce injection pain and procedure-related pain and improve perioperative haemostasis.
研究概览
地位
尚未招聘
详细说明
The aim of the project is to test the hypothesis that the following modifications during subcutaneous eyelid injection of local anaesthesia, compared to 2% lignocaine with 1:200,000 adrenaline, reduce injection pain and procedure-related pain and improve perioperative haemostasis.
- Buffering of 2% lignocaine with 1:200,000 adrenaline by adding sodium bicarbonate;
- Warming of 2% lignocaine with 1:200,000 adrenaline to 37°C;
- Addition of hyaluronidase to 2% lignocaine with 1:200,000 adrenaline; and
- Addition of tranexamic acid to 2% lignocaine with 1:200,000 adrenaline.
研究类型
介入性
注册 (估计的)
80
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Anson Chun Long Wu
- 电话号码：+852 35052878
- 邮箱：wcl589@ha.org.hk
学习地点
-
-
-
Hong Kong、香港
- Prince of Wales Hospital
-
接触：
- Anson Chun Long Wu
- 电话号码：+852 35052878
- 邮箱：wcl589@ha.org.hk
-
首席研究员：
- Kelvin Kam Lung Chong
-
Hong Kong、香港
- Alice Ho Miu Ling Nethersole Hospital
-
接触：
- Anson Chun Long Wu
- 电话号码：+852 35052878
- 邮箱：wcl589@ha.org.hk
-
首席研究员：
- Anson Chun Long Wu
-
Hong Kong、香港
- CUHK Medical Centre
-
接触：
- Kelvin Kam Lung Chong
- 电话号码：+852 39435824
- 邮箱：chongkamlung@cuhk.edu.hk
-
首席研究员：
- Kelvin Kam Lung Chong
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients undergoing bilateral upper eyelid blepharoplasty requiring subcutaneous anaesthesia at Prince of Wales Hospital, Alice Ho Miu Ling Nethersole Hospital and CUHK Medical Centre; and
- Adult patients aged 18 or above.
Exclusion Criteria:
- Patients aged less than 18;
- Pregnancy;
- Allergy to local anaesthetic agents;
- History of previous eyelid surgery; and
- Patients on antiplatelets or anticoagulants.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：First stage: Buffered
One eyelid: lignocaine buffered with sodium bicarbonate; the other eyelid: unmodified solution of lignocaine
|
Lignocaine buffered with sodium bicarbonate
2% lignocaine with 1:200,000 adrenaline
|
|
实验性的：First stage: Warmed
One eyelid: lignocaine warmed to body temperature; the other eyelid: unmodified solution of lignocaine at room temperature
|
2% lignocaine with 1:200,000 adrenaline
Lignocaine warmed to body temperature
|
|
实验性的：First stage: Hyaluronidase
One eyelid: lignocaine with hyaluronidase added; the other eyelid: unmodified solution of lignocaine
|
2% lignocaine with 1:200,000 adrenaline
Lignocaine with hyaluronidase added
|
|
实验性的：First stage: Tranexamic acid
One eyelid: lignocaine with tranexamic acid added; the other eyelid: unmodified solution of lignocaine
|
2% lignocaine with 1:200,000 adrenaline
Lignocaine with tranexamic acid added
|
|
实验性的：Second stage: Most effective modification A versus B
One eyelid: modification A; the other eyelid: modification B
|
Lignocaine buffered with sodium bicarbonate
2% lignocaine with 1:200,000 adrenaline
Lignocaine warmed to body temperature
Lignocaine with hyaluronidase added
Lignocaine with tranexamic acid added
|
|
实验性的：Second stage: Most effective modification A+B versus A
One eyelid: modification A+B; the other eyelid: modification A
|
Lignocaine buffered with sodium bicarbonate
2% lignocaine with 1:200,000 adrenaline
Lignocaine warmed to body temperature
Lignocaine with hyaluronidase added
Lignocaine with tranexamic acid added
|
|
实验性的：Second stage: Most effective modification A+B versus B
One eyelid: modification A+B; the other eyelid: modification B
|
Lignocaine buffered with sodium bicarbonate
2% lignocaine with 1:200,000 adrenaline
Lignocaine warmed to body temperature
Lignocaine with hyaluronidase added
Lignocaine with tranexamic acid added
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain of injection of local anaesthesia
大体时间：Within 1 minute after injection of local anaesthesia
|
Pain of injection of local anaesthesia, measured by a pain rating visual analogue scale of minimum 0 to maximum 10 (10 refers to worst pain)
|
Within 1 minute after injection of local anaesthesia
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pain encountered during the surgery
大体时间：Within 15 minutes after surgery
|
Pain encountered during the surgery, measured by a pain rating visual analogue scale of minimum 0 to maximum 10 (10 refers to worst pain)
|
Within 15 minutes after surgery
|
|
Pain encountered one week after surgery
大体时间：One week after surgery
|
Pain encountered one week after surgery, measured by a pain rating visual analogue scale of minimum 0 to maximum 10 (10 refers to worst pain)
|
One week after surgery
|
|
Postoperative ecchymosis at one week after surgery
大体时间：One week after surgery
|
Postoperative ecchymosis at one week after surgery, rated based on clinical photos using a standardised rating score of minimum 0 to maximum 5 (5 refers to worst ecchymosis)
|
One week after surgery
|
|
Postoperative swelling at one week after surgery
大体时间：One week after surgery
|
Postoperative swelling at one week after surgery, rated based on clinical photos using a standardised rating score of minimum 0 to maximum 5 (5 refers to worst swelling)
|
One week after surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Kelvin Kam Lung Chong、Prince of Wales Hospital, Shatin, Hong Kong
- 首席研究员：Anson Chun Long Wu、Prince of Wales Hospital, Shatin, Hong Kong
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2028年7月1日
研究完成 (估计的)
2028年7月1日
研究注册日期
首次提交
2026年7月19日
首先提交符合 QC 标准的
2026年7月24日
首次发布 (实际的)
2026年7月29日
研究记录更新
最后更新发布 (实际的)
2026年8月3日
上次提交的符合 QC 标准的更新
2026年7月30日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CREC-2025.390
- 13242776 (其他赠款/资助编号：Health Bureau)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request.
IPD 共享时间框架
The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request starting from the conclusion of the study to five years after study closure.
IPD 共享访问标准
The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.