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

30. juli 2026 oppdatert av: Wu Chun Long, Prince of Wales Hospital, Shatin, Hong Kong

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Anson Chun Long Wu
Telefonnummer: +852 35052878
E-post: wcl589@ha.org.hk

Studiesteder

Hong Kong
- - Hong Kong, Hong Kong
    - Prince of Wales Hospital
    - Ta kontakt med:
      
      Anson Chun Long Wu
      
      Telefonnummer: +852 35052878
      
      E-post: wcl589@ha.org.hk
    - Hovedetterforsker:
      
      Kelvin Kam Lung Chong
  - Hong Kong, Hong Kong
    - Alice Ho Miu Ling Nethersole Hospital
    - Ta kontakt med:
      
      Anson Chun Long Wu
      
      Telefonnummer: +852 35052878
      
      E-post: wcl589@ha.org.hk
    - Hovedetterforsker:
      
      Anson Chun Long Wu
  - Hong Kong, Hong Kong
    - CUHK Medical Centre
    - Ta kontakt med:
      
      Kelvin Kam Lung Chong
      
      Telefonnummer: +852 39435824
      
      E-post: chongkamlung@cuhk.edu.hk
    - Hovedetterforsker:
      
      Kelvin Kam Lung Chong

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Firemannsrom

Antall våpen

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Pain of injection of local anaesthesia Tidsramme: 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)	Within 1 minute after injection of local anaesthesia

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Pain encountered during the surgery Tidsramme: 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)	Within 15 minutes after surgery
Pain encountered one week after surgery Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Prince of Wales Hospital, Shatin, Hong Kong

Samarbeidspartnere

Chinese University of Hong Kong

Etterforskere

Studiestol: Kelvin Kam Lung Chong, Prince of Wales Hospital, Shatin, Hong Kong
Hovedetterforsker: Anson Chun Long Wu, Prince of Wales Hospital, Shatin, Hong Kong

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. juli 2028

Studiet fullført (Antatt)

1. juli 2028

Datoer for studieregistrering

Først innsendt

19. juli 2026

Først innsendt som oppfylte QC-kriteriene

24. juli 2026

Først lagt ut (Faktiske)

29. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

CREC-2025.390
13242776 (Annet stipend/finansieringsnummer: Health Bureau)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

IPD-planbeskrivelse

The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request.

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request.

IPD-deling Støtteinformasjonstype

STUDY_PROTOCOL
SEVJE
ICF
ANALYTIC_CODE
CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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