Perioperative Haemostasis, Procedure-Related Pain After Physiological or Pharmacological Modifications of Local Anaesthesia Around the Eyes (P4LE)
30. juli 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Anson Chun Long Wu
- Telefonnummer: +852 35052878
- E-mail: wcl589@ha.org.hk
Studiesteder
-
-
-
Hong Kong, Hong Kong
- Prince of Wales Hospital
-
Kontakt:
- Anson Chun Long Wu
- Telefonnummer: +852 35052878
- E-mail: wcl589@ha.org.hk
-
Ledende efterforsker:
- Kelvin Kam Lung Chong
-
Hong Kong, Hong Kong
- Alice Ho Miu Ling Nethersole Hospital
-
Kontakt:
- Anson Chun Long Wu
- Telefonnummer: +852 35052878
- E-mail: wcl589@ha.org.hk
-
Ledende efterforsker:
- Anson Chun Long Wu
-
Hong Kong, Hong Kong
- CUHK Medical Centre
-
Kontakt:
- Kelvin Kam Lung Chong
- Telefonnummer: +852 39435824
- E-mail: chongkamlung@cuhk.edu.hk
-
Ledende efterforsker:
- Kelvin Kam Lung Chong
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: First stage: Buffered
One eyelid: lignocaine buffered with sodium bicarbonate; the other eyelid: unmodified solution of lignocaine
|
Lignocaine buffered with sodium bicarbonate
2% lignocaine with 1:200,000 adrenaline
|
|
Eksperimentel: First stage: Warmed
One eyelid: lignocaine warmed to body temperature; the other eyelid: unmodified solution of lignocaine at room temperature
|
2% lignocaine with 1:200,000 adrenaline
Lignocaine warmed to body temperature
|
|
Eksperimentel: First stage: Hyaluronidase
One eyelid: lignocaine with hyaluronidase added; the other eyelid: unmodified solution of lignocaine
|
2% lignocaine with 1:200,000 adrenaline
Lignocaine with hyaluronidase added
|
|
Eksperimentel: First stage: Tranexamic acid
One eyelid: lignocaine with tranexamic acid added; the other eyelid: unmodified solution of lignocaine
|
2% lignocaine with 1:200,000 adrenaline
Lignocaine with tranexamic acid added
|
|
Eksperimentel: Second stage: Most effective modification A versus B
One eyelid: modification A; the other eyelid: modification B
|
Lignocaine buffered with sodium bicarbonate
2% lignocaine with 1:200,000 adrenaline
Lignocaine warmed to body temperature
Lignocaine with hyaluronidase added
Lignocaine with tranexamic acid added
|
|
Eksperimentel: Second stage: Most effective modification A+B versus A
One eyelid: modification A+B; the other eyelid: modification A
|
Lignocaine buffered with sodium bicarbonate
2% lignocaine with 1:200,000 adrenaline
Lignocaine warmed to body temperature
Lignocaine with hyaluronidase added
Lignocaine with tranexamic acid added
|
|
Eksperimentel: Second stage: Most effective modification A+B versus B
One eyelid: modification A+B; the other eyelid: modification B
|
Lignocaine buffered with sodium bicarbonate
2% lignocaine with 1:200,000 adrenaline
Lignocaine warmed to body temperature
Lignocaine with hyaluronidase added
Lignocaine with tranexamic acid added
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Studiestol: Kelvin Kam Lung Chong, Prince of Wales Hospital, Shatin, Hong Kong
- Ledende efterforsker: Anson Chun Long Wu, Prince of Wales Hospital, Shatin, Hong Kong
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. juli 2028
Studieafslutning (Anslået)
1. juli 2028
Datoer for studieregistrering
Først indsendt
19. juli 2026
Først indsendt, der opfyldte QC-kriterier
24. juli 2026
Først opslået (Faktiske)
29. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neurologiske manifestationer
- Genetiske sygdomme, medfødte
- Bindevævssygdomme
- Hudsygdomme
- Hudsygdomme, genetisk
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Patologiske tilstande, tegn og symptomer
- Hud- og bindevævssygdomme
- Tegn og symptomer
- Smerte
- Cutis Laxa
- Organiske kemikalier
- Carboxylsyrer
- Anilider
- Amider
- Anilinforbindelser
- Aminer
- Acetanilider
- Glykosidhydrolaser
- Hydrolaser
- Enzymer
- Enzymer og coenzymer
- Polysaccharid-lyaser
- Carbon-ilt lyaser
- Lyases
- Uorganiske kemikalier
- Syrer, carbocykliske
- Cyclohexanecarboxylsyrer
- Natriumforbindelser
- Carbonforbindelser, uorganisk
- Carbonater
- Kulsyre
- Bicarbonater
- Tranexaminsyre
- Lidokain
- Hyaluronoglucosaminidase
- Natriumbicarbonat
Andre undersøgelses-id-numre
- CREC-2025.390
- 13242776 (Andet bevillings-/finansieringsnummer: Health Bureau)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
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.
IPD-delingsadgangskriterier
The datasets used and/or analysed during the current study are available from the principal investigator on reasonable request.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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