Dermatochalasis of Upper EyelidPhase 3P4LENCT07734740
Perioperative Haemostasis, Procedure-Related Pain After Physiological or Pharmacological Modifications of Local Anaesthesia Around the Eyes
A Phase 3 study testing Sodium Bicarbonate (NaHCO3), Warmed lignocaine and Hyaluronidase Injection in people with Dermatochalasis of Upper Eyelid and Blepharoplasty, run by Prince of Wales Hospital, Shatin, Hong Kong at 3 sites in Hong Kong.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatochalasis of Upper Eyelid, Blepharoplasty
- What is being tested?
- Sodium Bicarbonate (NaHCO3), Warmed lignocaine and Hyaluronidase Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesHong Kong
- Study dates
- Aug 2026to Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients aged less than 18;
- Pregnancy;
- Allergy to local anaesthetic agents;
- History of previous eyelid surgery; and
- Patients on antiplatelets or anticoagulants.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong3 sites
Alice Ho Miu Ling Nethersole Hospital
Hong Kong
Anson Chun Long Wu, +852 35052878, wcl589@ha.org.hk
Anson Chun Long Wu
CUHK Medical Centre
Hong Kong
Kelvin Kam Lung Chong, +852 39435824, chongkamlung@cuhk.edu.hk
Kelvin Kam Lung Chong
Prince of Wales Hospital
Hong Kong
Anson Chun Long Wu, +852 35052878, wcl589@ha.org.hk
Kelvin Kam Lung Chong
About this study
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
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.
- 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.
- Conditions
- Dermatochalasis of Upper Eyelid, Blepharoplasty
- Being tested
- Sodium Bicarbonate (NaHCO3), Warmed lignocaine, Hyaluronidase Injection, Tranexamic Acid (TXA), Lignocaine 2% concentration solution
- Keywords
- Dermatochalasis, Blepharoplasty, Local anaesthesia, Lignocaine, Sodium bicarbonate, Hyaluronidase, Tranexamic acid, Buffered, Warmed, Pain, Haemostasis
- Medical subject headings
- Cutis Laxa, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate (NaHCO3)Drug
Lignocaine buffered with sodium bicarbonate
Warmed lignocaineDrug
Lignocaine warmed to body temperature
Hyaluronidase InjectionDrug
Lignocaine with hyaluronidase added
Tranexamic Acid (TXA)Drug
Lignocaine with tranexamic acid added
Lignocaine 2% concentration solutionDrug
2% lignocaine with 1:200,000 adrenaline
| Study group | Role | What they receive |
|---|---|---|
| First stage: Buffered | Experimental | One eyelid: lignocaine buffered with sodium bicarbonate; the other eyelid: unmodified solution of lignocaine Receives: Drug: Sodium Bicarbonate (NaHCO3); Drug: Lignocaine 2% concentration solution |
| First stage: Warmed | Experimental | One eyelid: lignocaine warmed to body temperature; the other eyelid: unmodified solution of lignocaine at room temperature Receives: Drug: Warmed lignocaine; Drug: Lignocaine 2% concentration solution |
| First stage: Hyaluronidase | Experimental | One eyelid: lignocaine with hyaluronidase added; the other eyelid: unmodified solution of lignocaine Receives: Drug: Hyaluronidase Injection; Drug: Lignocaine 2% concentration solution |
| First stage: Tranexamic acid | Experimental | One eyelid: lignocaine with tranexamic acid added; the other eyelid: unmodified solution of lignocaine Receives: Drug: Tranexamic Acid (TXA); Drug: Lignocaine 2% concentration solution |
| Second stage: Most effective modification A versus B | Experimental | One eyelid: modification A; the other eyelid: modification B Receives: Drug: Sodium Bicarbonate (NaHCO3); Drug: Warmed lignocaine; Drug: Hyaluronidase Injection; Drug: Tranexamic Acid (TXA); Drug: Lignocaine 2% concentration solution |
| Second stage: Most effective modification A+B versus A | Experimental | One eyelid: modification A+B; the other eyelid: modification A Receives: Drug: Sodium Bicarbonate (NaHCO3); Drug: Warmed lignocaine; Drug: Hyaluronidase Injection; Drug: Tranexamic Acid (TXA); Drug: Lignocaine 2% concentration solution |
| Second stage: Most effective modification A+B versus B | Experimental | One eyelid: modification A+B; the other eyelid: modification B Receives: Drug: Sodium Bicarbonate (NaHCO3); Drug: Warmed lignocaine; Drug: Hyaluronidase Injection; Drug: Tranexamic Acid (TXA); Drug: Lignocaine 2% concentration solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Within 1 minute after injection of local anaesthesia
Secondary outcomes (4)
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)
Measured: Within 15 minutes after surgery
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)
Measured: One week after surgery
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)
Measured: One week after surgery
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)
Measured: One week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatochalasis of Upper EyelidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Wu Chun Long, Prince of Wales Hospital, Shatin, Hong Kong
- Investigators
- Kelvin Kam Lung Chong, Study chair, Prince of Wales Hospital, Shatin, Hong KongAnson Chun Long Wu, Principal investigator, Prince of Wales Hospital, Shatin, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734740
- Sponsor's protocol ID
- CREC-2025.390
- Other IDs
- 13242776
- Acronym
- P4LE
- Status last verified
- Jul 2026
- First submitted
- 19 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07734740
- Acronym / sponsor ID
- P4LE / CREC-2025.390
- Conditions
- Dermatochalasis of Upper Eyelid, Blepharoplasty
- Keywords
- Dermatochalasis, Blepharoplasty, Local anaesthesia, Lignocaine, Sodium bicarbonate, Hyaluronidase, Tranexamic acid, Buffered
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Prince of Wales Hospital, Shatin, Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| First stage: Buffered | Experimental | Drug: Sodium Bicarbonate (NaHCO3), Drug: Lignocaine 2% concentration solutionOne eyelid: lignocaine buffered with sodium bicarbonate; the other eyelid: unmodified solution of lignocaine |
| First stage: Warmed | Experimental | Drug: Warmed lignocaine, Drug: Lignocaine 2% concentration solutionOne eyelid: lignocaine warmed to body temperature; the other eyelid: unmodified solution of lignocaine at room temperature |
| First stage: Hyaluronidase | Experimental | Drug: Hyaluronidase Injection, Drug: Lignocaine 2% concentration solutionOne eyelid: lignocaine with hyaluronidase added; the other eyelid: unmodified solution of lignocaine |
| First stage: Tranexamic acid | Experimental | Drug: Tranexamic Acid (TXA), Drug: Lignocaine 2% concentration solutionOne eyelid: lignocaine with tranexamic acid added; the other eyelid: unmodified solution of lignocaine |
| Second stage: Most effective modification A versus B | Experimental | Drug: Sodium Bicarbonate (NaHCO3), Drug: Warmed lignocaine, Drug: Hyaluronidase Injection, Drug: Tranexamic Acid (TXA), Drug: Lignocaine 2% concentration solutionOne eyelid: modification A; the other eyelid: modification B |
| Second stage: Most effective modification A+B versus A | Experimental | Drug: Sodium Bicarbonate (NaHCO3), Drug: Warmed lignocaine, Drug: Hyaluronidase Injection, Drug: Tranexamic Acid (TXA), Drug: Lignocaine 2% concentration solutionOne eyelid: modification A+B; the other eyelid: modification A |
| Second stage: Most effective modification A+B versus B | Experimental | Drug: Sodium Bicarbonate (NaHCO3), Drug: Warmed lignocaine, Drug: Hyaluronidase Injection, Drug: Tranexamic Acid (TXA), Drug: Lignocaine 2% concentration solutionOne eyelid: modification A+B; the other eyelid: modification B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- Patients aged less than 18;
- Pregnancy;
- Allergy to local anaesthetic agents;
- History of previous eyelid surgery; and
- Patients on antiplatelets or anticoagulants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Bicarbonate (NaHCO3)Lignocaine buffered with sodium bicarbonate | Drug | First stage: Buffered, Second stage: Most effective modification A versus B, Second stage: Most effective modification A+B versus A, Second stage: Most effective modification A+B versus B |
| Warmed lignocaineLignocaine warmed to body temperature | Drug | First stage: Warmed, Second stage: Most effective modification A versus B, Second stage: Most effective modification A+B versus A, Second stage: Most effective modification A+B versus B |
| Hyaluronidase InjectionLignocaine with hyaluronidase added | Drug | First stage: Hyaluronidase, Second stage: Most effective modification A versus B, Second stage: Most effective modification A+B versus A, Second stage: Most effective modification A+B versus B |
| Tranexamic Acid (TXA)Lignocaine with tranexamic acid added | Drug | First stage: Tranexamic acid, Second stage: Most effective modification A versus B, Second stage: Most effective modification A+B versus A, Second stage: Most effective modification A+B versus B |
| Lignocaine 2% concentration solution2% lignocaine with 1:200,000 adrenaline | Drug | First stage: Buffered, First stage: Hyaluronidase, First stage: Tranexamic acid, First stage: Warmed, Second stage: Most effective modification A versus B, Second stage: Most effective modification A+B versus A, Second stage: Most effective modification A+B versus B |
Primary outcome
Pain of injection of local anaesthesia
Time frame: 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)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request.
Related trials for Dermatochalasis of Upper Eyelid
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Dermatochalasis of Upper Eyelid, Ptosis, Eyelid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Bicarbonate (NaHCO3), Warmed lignocaine and Hyaluronidase Injection in people with Dermatochalasis of Upper Eyelid and Blepharoplasty, run by Prince of Wales Hospital, Shatin, Hong Kong at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anson Chun Long Wu (+852 35052878, wcl589@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain of injection of local anaesthesia (time frame: Within 1 minute after injection of local anaesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.