Perioperative Haemostasis, Procedure-Related Pain After Physiological or Pharmacological Modifications of Local Anaesthesia Around the Eyes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sodium Bicarbonate (NaHCO3), Warmed lignocaine, Hyaluronidase Injection, Tranexamic Acid (TXA).
- Who it may be relevant to
- Registry conditions: Dermatochalasis of Upper Eyelid, Blepharoplasty. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
1. Buffering of 2% lignocaine with 1:200,000 adrenaline by adding sodium bicarbonate; 2. Warming of 2% lignocaine with 1:200,000 adrenaline to 37°C; 3. Addition of hyaluronidase to 2% lignocaine with 1:200,000 adrenaline; and 4. Addition of tranexamic acid to 2% lignocaine with 1:200,000 adrenaline.
Interventions
- Drug Sodium Bicarbonate (NaHCO3)
Lignocaine buffered with sodium bicarbonate - Drug Warmed lignocaine
Lignocaine warmed to body temperature - Drug Hyaluronidase Injection
Lignocaine with hyaluronidase added - Drug Tranexamic Acid (TXA)
Lignocaine with tranexamic acid added - Drug Lignocaine 2% concentration solution
2% lignocaine with 1:200,000 adrenaline
Primary outcome measures
- Pain of injection of local anaesthesia [Time frame: Within 1 minute after injection of local anaesthesia]
Secondary outcome measures (4)
- Pain encountered during the surgery [Time frame: Within 15 minutes after surgery]
- Pain encountered one week after surgery [Time frame: One week after surgery]
- Postoperative ecchymosis at one week after surgery [Time frame: One week after surgery]
- Postoperative swelling at one week after surgery [Time frame: One week after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Hong Kong · 3 centers
- Alice Ho Miu Ling Nethersole Hospital — Hong Kong
- CUHK Medical Centre — Hong Kong
- Prince of Wales Hospital — Hong Kong
Identifiers
NCT: NCT07734740 · CREC-2025.390 · 13242776