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Not yet recruitingNCT07734740P4LEUpdated Aug 3, 2026

Perioperative Haemostasis, Procedure-Related Pain After Physiological or Pharmacological Modifications of Local Anaesthesia Around the Eyes

A Phase 3 interventional study of Sodium Bicarbonate (NaHCO3) and Warmed lignocaine in Dermatochalasis of Upper Eyelid and Blepharoplasty, sponsored by Prince of Wales Hospital, Shatin, Hong Kong. Not yet recruiting at 3 sites in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Prince of Wales Hospital, Shatin, Hong Kong · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Dermatochalasis of Upper Eyelid
  • Blepharoplasty

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Keywords

  • Dermatochalasis
  • Blepharoplasty
  • Local anaesthesia
  • Lignocaine
  • Sodium bicarbonate
  • Hyaluronidase
  • Tranexamic acid
  • Buffered
  • Warmed
  • Pain
  • Haemostasis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Patients aged less than 18;
  • Pregnancy;
  • Allergy to local anaesthetic agents;
  • History of previous eyelid surgery; and
  • Patients on antiplatelets or anticoagulants.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    First stage: Buffered

    One eyelid: lignocaine buffered with sodium bicarbonate; the other eyelid: unmodified solution of lignocaine

    Drug: Sodium Bicarbonate (NaHCO3) · Drug: Lignocaine 2% concentration solution

  • Experimental
    First stage: Warmed

    One eyelid: lignocaine warmed to body temperature; the other eyelid: unmodified solution of lignocaine at room temperature

    Drug: Warmed lignocaine · Drug: Lignocaine 2% concentration solution

  • Experimental
    First stage: Hyaluronidase

    One eyelid: lignocaine with hyaluronidase added; the other eyelid: unmodified solution of lignocaine

    Drug: Hyaluronidase Injection · Drug: Lignocaine 2% concentration solution

  • Experimental
    First stage: Tranexamic acid

    One eyelid: lignocaine with tranexamic acid added; the other eyelid: unmodified solution of lignocaine

    Drug: Tranexamic Acid (TXA) · Drug: Lignocaine 2% concentration solution

  • Experimental
    Second stage: Most effective modification A versus B

    One eyelid: modification A; the other eyelid: modification B

    Drug: Sodium Bicarbonate (NaHCO3) · Drug: Warmed lignocaine · Drug: Hyaluronidase Injection · Drug: Tranexamic Acid (TXA) · Drug: Lignocaine 2% concentration solution

  • Experimental
    Second stage: Most effective modification A+B versus A

    One eyelid: modification A+B; the other eyelid: modification A

    Drug: Sodium Bicarbonate (NaHCO3) · Drug: Warmed lignocaine · Drug: Hyaluronidase Injection · Drug: Tranexamic Acid (TXA) · Drug: Lignocaine 2% concentration solution

  • Experimental
    Second stage: Most effective modification A+B versus B

    One eyelid: modification A+B; the other eyelid: modification B

    Drug: Sodium Bicarbonate (NaHCO3) · Drug: Warmed lignocaine · Drug: Hyaluronidase Injection · Drug: Tranexamic Acid (TXA) · Drug: Lignocaine 2% concentration solution

Interventions

  • DrugSodium Bicarbonate (NaHCO3)

    Lignocaine buffered with sodium bicarbonate

  • DrugWarmed lignocaine

    Lignocaine warmed to body temperature

  • DrugHyaluronidase Injection

    Lignocaine with hyaluronidase added

  • DrugTranexamic Acid (TXA)

    Lignocaine with tranexamic acid added

  • DrugLignocaine 2% concentration solution

    2% lignocaine with 1:200,000 adrenaline

05

What researchers measure

Primary outcomes

  1. Pain of 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)

    Time frame: Within 1 minute after injection of local anaesthesia

Secondary outcomes

  1. Pain encountered during the 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)

    Time frame: Within 15 minutes after surgery

  2. Pain encountered 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)

    Time frame: One week after surgery

  3. Postoperative ecchymosis at 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)

    Time frame: One week after surgery

  4. Postoperative swelling at 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)

    Time frame: One week after surgery

06

Study locations

3 sites
  • Alice Ho Miu Ling Nethersole Hospital
    Hong Kong, Hong Kong
    • Anson Chun Long Wu · Contact · wcl589@ha.org.hk · +852 35052878
    • Anson Chun Long Wu · Principal investigator
  • CUHK Medical Centre
    Hong Kong, Hong Kong
    • Kelvin Kam Lung Chong · Contact · chongkamlung@cuhk.edu.hk · +852 39435824
    • Kelvin Kam Lung Chong · Principal investigator
  • Prince of Wales Hospital
    Hong Kong, Hong Kong
    • Anson Chun Long Wu · Contact · wcl589@ha.org.hk · +852 35052878
    • Kelvin Kam Lung Chong · Principal investigator
07

References and documents

Study documents

  • Study protocol · Dec 8, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT07734740
Lead sponsor
Prince of Wales Hospital, Shatin, Hong Kong
Collaborators
Chinese University of Hong Kong
Responsible party
Wu Chun Long (Principal Investigator, Prince of Wales Hospital, Shatin, Hong Kong) — Principal investigator
First posted
Jul 29, 2026
Start date
Aug 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Aug 3, 2026

Study contacts

Anson Chun Long Wu
Contact
wcl589@ha.org.hk
+852 35052878
Kelvin Kam Lung Chong
study chair · Prince of Wales Hospital, Shatin, Hong Kong
Anson Chun Long Wu
principal investigator · Prince of Wales Hospital, Shatin, Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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