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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

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 80 is above the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong is the lead sponsor of 27 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
05

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

06

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

07

Study locations

3 sites
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: 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.

Access criteria: The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Jul 2028, 23 months later.

Of 110 non-industry phase 3 interventional studies under Pain, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 23 months is below that.

Counting every sponsor, half of 215 studies reached it within 18 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 19, 2026
First posted
Jul 29, 2026
StartEst.
Aug 2026
Primary completionEst.
Jul 2028
CompletionEst.
Jul 2028
Last update
Aug 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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Studies of the drugs tested here: Sodium Bicarbonate · Hyaluronoglucosaminidase · Tranexamic Acid

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Prince of Wales Hospital, Shatin, Hong Kong

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