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

NCT07734740 | Not Yet Recruiting Phase 3

• 2 other identifiers: CREC-2025.39013242776
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Dermatochalasis of Upper Eyelid; Blepharoplasty

Keywords

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

Outcome Measures

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)

  Within 1 minute after injection of local anaesthesia

Secondary Outcomes (4)

• Pain encountered during the surgery

  Within 15 minutes after surgery

• Pain encountered one week after surgery

  One week after surgery

• Postoperative ecchymosis at one week after surgery

  One week after surgery

• Postoperative swelling at one week after surgery

  One week after surgery

Study Arms (7)

First stage: Buffered

EXPERIMENTAL

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

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

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

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

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

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

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

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

Interventions

Sodium Bicarbonate (NaHCO3) DRUG

Lignocaine buffered with sodium bicarbonate

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 lignocaine DRUG

Lignocaine warmed to body temperature

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 Injection DRUG

Lignocaine with hyaluronidase added

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) DRUG

Lignocaine with tranexamic acid added

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 solution DRUG

2% lignocaine with 1:200,000 adrenaline

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Prince of Wales Hospital, Shatin, Hong Kong: lead
• Chinese University of Hong Kong: collaborator

Study Sites (3)

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hong Kong

Location

CUHK Medical Centre

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Cutis Laxa; Pain

Interventions

Sodium Bicarbonate; Hyaluronoglucosaminidase; Tranexamic Acid; Lidocaine

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Polysaccharide-Lyases; Carbon-Oxygen Lyases; Lyases; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Kelvin Kam Lung Chong

  Prince of Wales Hospital, Shatin, Hong Kong

  STUDY CHAIR

• Anson Chun Long Wu

  Prince of Wales Hospital, Shatin, Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anson Chun Long Wu

CONTACT

+852 35052878; wcl589@ha.org.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: July 19, 2026
• First Posted: July 29, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

HK (3)