Perioperative Haemostasis, Procedure-Related Pain After Physiological or Pharmacological Modifications of Local Anaesthesia Around the Eyes (P4LE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Blepharoplasty; Dermatochalasis of Upper Eyelid
• Intervention / Treatment: Drug: Sodium Bicarbonate (NaHCO3); Drug: Lignocaine 2% concentration solution; Drug: Warmed lignocaine; Drug: Hyaluronidase Injection; Drug: Tranexamic Acid (TXA)

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Anson Chun Long Wu; Phone Number: +852 35052878; Email: wcl589@ha.org.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
    • Contact: Anson Chun Long Wu; Phone Number: +852 35052878; Email: wcl589@ha.org.hk
    • Principal Investigator: Kelvin Kam Lung Chong
  • Hong Kong, Hong Kong
    • Alice Ho Miu Ling Nethersole Hospital
    • Contact: Anson Chun Long Wu; Phone Number: +852 35052878; Email: wcl589@ha.org.hk
    • Principal Investigator: Anson Chun Long Wu
  • Hong Kong, Hong Kong
    • CUHK Medical Centre
    • Contact: Kelvin Kam Lung Chong; Phone Number: +852 39435824; Email: chongkamlung@cuhk.edu.hk
    • Principal Investigator: Kelvin Kam Lung Chong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First stage: Buffered; One eyelid: lignocaine buffered with sodium bicarbonate; the other eyelid: unmodified solution of lignocaine	Drug: Sodium Bicarbonate (NaHCO3); Lignocaine buffered with sodium bicarbonate; Drug: Lignocaine 2% concentration solution; 2% lignocaine with 1:200,000 adrenaline
Experimental: First stage: Warmed; One eyelid: lignocaine warmed to body temperature; the other eyelid: unmodified solution of lignocaine at room temperature	Drug: Lignocaine 2% concentration solution; 2% lignocaine with 1:200,000 adrenaline; Drug: Warmed lignocaine; Lignocaine warmed to body temperature
Experimental: First stage: Hyaluronidase; One eyelid: lignocaine with hyaluronidase added; the other eyelid: unmodified solution of lignocaine	Drug: Lignocaine 2% concentration solution; 2% lignocaine with 1:200,000 adrenaline; Drug: Hyaluronidase Injection; Lignocaine with hyaluronidase added
Experimental: First stage: Tranexamic acid; One eyelid: lignocaine with tranexamic acid added; the other eyelid: unmodified solution of lignocaine	Drug: Lignocaine 2% concentration solution; 2% lignocaine with 1:200,000 adrenaline; Drug: Tranexamic Acid (TXA); Lignocaine with tranexamic acid added
Experimental: Second stage: Most effective modification A versus B; One eyelid: modification A; the other eyelid: modification B	Drug: Sodium Bicarbonate (NaHCO3); Lignocaine buffered with sodium bicarbonate; Drug: Lignocaine 2% concentration solution; 2% lignocaine with 1:200,000 adrenaline; Drug: Warmed lignocaine; Lignocaine warmed to body temperature; Drug: Hyaluronidase Injection; Lignocaine with hyaluronidase added; Drug: Tranexamic Acid (TXA); Lignocaine with tranexamic acid added
Experimental: Second stage: Most effective modification A+B versus A; One eyelid: modification A+B; the other eyelid: modification A	Drug: Sodium Bicarbonate (NaHCO3); Lignocaine buffered with sodium bicarbonate; Drug: Lignocaine 2% concentration solution; 2% lignocaine with 1:200,000 adrenaline; Drug: Warmed lignocaine; Lignocaine warmed to body temperature; Drug: Hyaluronidase Injection; Lignocaine with hyaluronidase added; Drug: Tranexamic Acid (TXA); Lignocaine with tranexamic acid added
Experimental: Second stage: Most effective modification A+B versus B; One eyelid: modification A+B; the other eyelid: modification B	Drug: Sodium Bicarbonate (NaHCO3); Lignocaine buffered with sodium bicarbonate; Drug: Lignocaine 2% concentration solution; 2% lignocaine with 1:200,000 adrenaline; Drug: Warmed lignocaine; Lignocaine warmed to body temperature; Drug: Hyaluronidase Injection; Lignocaine with hyaluronidase added; Drug: Tranexamic Acid (TXA); Lignocaine with tranexamic acid added

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Within 1 minute after injection of local anaesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	One week after surgery

Collaborators and Investigators

• Sponsor: Prince of Wales Hospital, Shatin, Hong Kong
• Collaborators: Chinese University of Hong Kong
• Investigators: Study Chair: Kelvin Kam Lung Chong, Prince of Wales Hospital, Shatin, Hong Kong; Principal Investigator: Anson Chun Long Wu, Prince of Wales Hospital, Shatin, Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: July 19, 2026
• First Submitted That Met QC Criteria: July 24, 2026
• First Posted (Actual): July 29, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Pain; Tranexamic acid; Lignocaine; Hyaluronidase; Sodium bicarbonate; Blepharoplasty; Dermatochalasis; Local anaesthesia; Haemostasis; Buffered; Warmed
• Additional Relevant MeSH Terms: Neurologic Manifestations; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases; Skin Diseases, Genetic; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Pain; Cutis Laxa; Organic Chemicals; Carboxylic Acids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Inorganic Chemicals; Acids, Carbocyclic; Cyclohexanecarboxylic Acids; Sodium Compounds; Carbon Compounds, Inorganic; Carbonates; Carbonic Acid; Bicarbonates; Tranexamic Acid; Lidocaine; Hyaluronoglucosaminidase; Sodium Bicarbonate
• Other Study ID Numbers: CREC-2025.390; 13242776 (Other Grant/Funding Number: Health Bureau)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request.
• IPD Sharing 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.
• IPD Sharing Access Criteria: The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No