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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119058
Enrollment
Unknown
Registered
2026-02-14
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatochalasis

Interventions

First stage: Buffered :One eyelid: lignocaine buffered with sodium bicarbonate
The other eyelid: unmodified solution of lignocaine
First stage: Warmed :One eyelid: lignocaine warmed to body temperature
The other eyelid: unmodified solution of lignocaine at room temperature
First stage: Hyaluronidase :One eyelid: lignocaine with hyaluronidase added
First stage: Tranexamic acid:One eyelid: lignocaine with tranexamic acid added
Second stage: Most effective modification A versus B :One eyelid: modification A
The other eyelid: modification B
Second stage: Most effective modification A+B versus A :One eyelid: modification A+B
The other eyelid: modification A
Second stage: Most effective modification A+B versus B :One eyelid: modification A+B

Sponsors

Department of Ophthalmology and Visual Sciences (DOVS), Chinese University of Hong Kong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients undergoing bilateral upper eyelid blepharoplasty requiring subcutaneous anaesthesia at Prince of Wales Hospital, Alice Ho Miu Ling Nethersole Hospital and CUHK Medical Centre; 2.Adult patients aged 18 or above.

Exclusion criteria

Exclusion criteria: 1.Patients aged less than 18; 2.pregnancy; 3.allergy to local anaesthetic agents; 4.history of previous eyelid surgery; 5.patients on antiplatelets or anticoagulants.

Design outcomes

Primary

MeasureTime frame
Pain of injection of local anaesthesia;—

Secondary

MeasureTime frame
Pain encountered during the surgery;Pain encountered one week after surgery;Postoperative ecchymosis at one week after surgery;Postoperative swelling at one week after surgery;—

Countries

China

Contacts

Public ContactWU Chun Long Anson

Department of Ophthalmology and Visual Sciences, Prince of Wales Hospital; Department of Ophthalmology and Visual Sciences, Alice Ho Miu Ling Nethersole Hospital; Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

wcl589@ha.org.hk+852 3505 2878

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026