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

ConditionsDermatochalasis of Upper EyelidBlepharoplasty
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrince of Wales Hospital, Shatin, Hong Kong

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients aged less than 18;

Pregnancy;

Allergy to local anaesthetic agents;

History of previous eyelid surgery; and

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: First stage: BufferedExperimental treatment 2 interventions
Group B: First stage: WarmedExperimental treatment 2 interventions
Group C: First stage: HyaluronidaseExperimental treatment 2 interventions
Group D: First stage: Tranexamic acidExperimental treatment 2 interventions
Group E: Second stage: Most effective modification A versus BExperimental treatment 5 interventions
Group F: Second stage: Most effective modification A+B versus AExperimental treatment 5 interventions
Group G: Second stage: Most effective modification A+B versus BExperimental treatment 5 interventions

Trial outcomes

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)

Time frame
Within 1 minute after injection of local anaesthesia

Secondary outcomes

1

Pain encountered during the 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)

Time frame
Within 15 minutes after surgery
2

Pain encountered 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)

Time frame
One week after surgery
3

Postoperative ecchymosis at 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)

Time frame
One week after surgery
4

Postoperative swelling at 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)

Time frame
One week after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prince of Wales Hospital, Shatin, Hong Kong

Lead sponsor

Chinese University of Hong Kong

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: