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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Pain of injection of local anaesthesia
研究概览
简要总结
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.
详细描述
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)
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
- •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.
排除标准
- •Patients aged less than 18;
- •Pregnancy;
- •Allergy to local anaesthetic agents;
- •History of previous eyelid surgery; and
- •Patients on antiplatelets or anticoagulants.
研究组 & 干预措施
Second stage: Most effective modification A+B versus A
One eyelid: modification A+B; the other eyelid: modification A
干预措施: Hyaluronidase Injection (Drug)
Second stage: Most effective modification A versus B
One eyelid: modification A; the other eyelid: modification B
干预措施: Hyaluronidase Injection (Drug)
First stage: Hyaluronidase
One eyelid: lignocaine with hyaluronidase added; the other eyelid: unmodified solution of lignocaine
干预措施: Hyaluronidase Injection (Drug)
Second stage: Most effective modification A+B versus B
One eyelid: modification A+B; the other eyelid: modification B
干预措施: Hyaluronidase Injection (Drug)
First stage: Buffered
One eyelid: lignocaine buffered with sodium bicarbonate; the other eyelid: unmodified solution of lignocaine
干预措施: Lignocaine 2% concentration solution (Drug)
First stage: Warmed
One eyelid: lignocaine warmed to body temperature; the other eyelid: unmodified solution of lignocaine at room temperature
干预措施: Warmed lignocaine (Drug)
First stage: Warmed
One eyelid: lignocaine warmed to body temperature; the other eyelid: unmodified solution of lignocaine at room temperature
干预措施: Lignocaine 2% concentration solution (Drug)
First stage: Hyaluronidase
One eyelid: lignocaine with hyaluronidase added; the other eyelid: unmodified solution of lignocaine
干预措施: Lignocaine 2% concentration solution (Drug)
First stage: Tranexamic acid
One eyelid: lignocaine with tranexamic acid added; the other eyelid: unmodified solution of lignocaine
干预措施: Tranexamic Acid (TXA) (Drug)
Second stage: Most effective modification A versus B
One eyelid: modification A; the other eyelid: modification B
干预措施: Sodium Bicarbonate (NaHCO3) (Drug)
Second stage: Most effective modification A+B versus A
One eyelid: modification A+B; the other eyelid: modification A
干预措施: Sodium Bicarbonate (NaHCO3) (Drug)
Second stage: Most effective modification A+B versus B
One eyelid: modification A+B; the other eyelid: modification B
干预措施: Tranexamic Acid (TXA) (Drug)
Second stage: Most effective modification A+B versus B
One eyelid: modification A+B; the other eyelid: modification B
干预措施: Lignocaine 2% concentration solution (Drug)
First stage: Buffered
One eyelid: lignocaine buffered with sodium bicarbonate; the other eyelid: unmodified solution of lignocaine
干预措施: Sodium Bicarbonate (NaHCO3) (Drug)
First stage: Tranexamic acid
One eyelid: lignocaine with tranexamic acid added; the other eyelid: unmodified solution of lignocaine
干预措施: Lignocaine 2% concentration solution (Drug)
Second stage: Most effective modification A versus B
One eyelid: modification A; the other eyelid: modification B
干预措施: Warmed lignocaine (Drug)
Second stage: Most effective modification A versus B
One eyelid: modification A; the other eyelid: modification B
干预措施: Tranexamic Acid (TXA) (Drug)
Second stage: Most effective modification A versus B
One eyelid: modification A; the other eyelid: modification B
干预措施: Lignocaine 2% concentration solution (Drug)
Second stage: Most effective modification A+B versus A
One eyelid: modification A+B; the other eyelid: modification A
干预措施: Warmed lignocaine (Drug)
Second stage: Most effective modification A+B versus A
One eyelid: modification A+B; the other eyelid: modification A
干预措施: Tranexamic Acid (TXA) (Drug)
Second stage: Most effective modification A+B versus A
One eyelid: modification A+B; the other eyelid: modification A
干预措施: Lignocaine 2% concentration solution (Drug)
Second stage: Most effective modification A+B versus B
One eyelid: modification A+B; the other eyelid: modification B
干预措施: Sodium Bicarbonate (NaHCO3) (Drug)
Second stage: Most effective modification A+B versus B
One eyelid: modification A+B; the other eyelid: modification B
干预措施: Warmed lignocaine (Drug)
结局指标
主要结局
Pain of injection of local anaesthesia
时间窗: 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)
次要结局
- Pain encountered during the surgery(Within 15 minutes after surgery)
- Pain encountered one week after surgery(One week after surgery)
- Postoperative ecchymosis at one week after surgery(One week after surgery)
- Postoperative swelling at one week after surgery(One week after surgery)
研究者
Wu Chun Long
Principal Investigator
Prince of Wales Hospital, Shatin, Hong Kong