Dermatochalasis of Upper Eyelid, Blepharoplasty
Conditions
Keywords
Dermatochalasis, Blepharoplasty, Local anaesthesia, Lignocaine, Sodium bicarbonate, Hyaluronidase, Tranexamic acid, Buffered, Warmed, Pain, Haemostasis
Brief summary
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
Lignocaine buffered with sodium bicarbonate
DRUGWarmed lignocaine
Lignocaine warmed to body temperature
Lignocaine with hyaluronidase added
DRUGTranexamic Acid (TXA)
Lignocaine with tranexamic acid added
2% lignocaine with 1:200,000 adrenaline
Sponsors
Prince of Wales Hospital, Shatin, Hong Kong
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain of injection of local anaesthesia | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain encountered during the surgery | 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) |
| Pain encountered one week after surgery | 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) |
| Postoperative ecchymosis at one week after surgery | 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) |
| Postoperative swelling at one week after surgery | 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) |
Countries
Hong Kong
Contacts
CONTACTAnson Chun Long Wu
STUDY_CHAIRKelvin Kam Lung Chong
Prince of Wales Hospital, Shatin, Hong Kong
PRINCIPAL_INVESTIGATORAnson Chun Long Wu
Prince of Wales Hospital, Shatin, Hong Kong
Outcome results
None listed