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NCT Number: NCT07734740

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

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.

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Key information

Conditions

Dermatochalasis of Upper Eyelid Blepharoplasty Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Genetic Diseases, Inborn Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alice Ho Miu Ling Nethersole Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sodium Bicarbonate (NaHCO3)

Drug

Lignocaine buffered with sodium bicarbonate

Warmed lignocaine

Drug

Lignocaine warmed to body temperature

Hyaluronidase Injection

Drug

Lignocaine with hyaluronidase added

Tranexamic acid (TXA)

Drug

Lignocaine with tranexamic acid added

Lignocaine 2% concentration solution

Drug

2% lignocaine with 1:200,000 adrenaline

Primary outcomes

  1. 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)

Secondary outcomes

  1. Pain encountered during the surgery

    Time frame: Within 15 minutes after 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)

  2. Pain encountered one week after surgery

    Time frame: 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)

  3. Postoperative ecchymosis at one week after surgery

    Time frame: 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)

  4. Postoperative swelling at one week after surgery

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Anson Chun Long Wu

CONTACT

[email protected]

+852 35052878

Sponsors and collaborators

Lead sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Other

Collaborators

  • Chinese University of Hong Kong

Registry information

Official study 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

Acronym: P4LE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 29, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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