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Completed

NCT Number: NCT06121141

Comparison of Two Different Concentrations of Local Anesthetic in Patient Reported Pain in Oculoplastic Surgery

The goal of this clinical trial is to compare pain scores in people undergoing upper eyelid surgery. The main questions it aims to answer are:

* Is one concentration of local anesthetic (also called numbing or freezing injection) less painful when it is injected? * Does one concentration of local anesthetic provide better pain control during surgery? Participants will have two different concentrations of local anesthetic injected into the upper eyelid skin prior to surgery, and will be asked to rate the pain they have during the injection. At the end of surgery, they will be asked to rate the pain they have during surgery.

Researchers will compare the pain scores to see if one of the concentrations is less painful during the injection and to see if one of the concentrations provides better pain control during surgery.

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Key information

Conditions

Dermatochalasis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutis Laxa Dermatochalasis of Both Eyes Dermatochalasis of Both Upper Eyelids Dermatochalasis of Eyelid Dermatochalasis of Left Upper Eyelid Dermatochalasis of Right Upper Eyelid 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 4

Primary location

Fraser Valley Cataract and Laser

Surrey, British Columbia, V3S5K7, Canada

About this study

Purpose:

The purpose of this study is to evaluate the level of pain experienced during injection of dilute local anesthetic when compared to non-dilute local anesthetic for oculoplastic surgery. It will also evaluate the level of pain experienced during surgery when comparing dilute local anesthetic to non-dilute local anesthetic for oculoplastic surgery.

Study design:

Randomized, double-blind study of 30 patients undergoing elective bilateral upper eyelid blepharoplasty, for a total of 60 eyes having surgery. For each patient, one side will be injected using the control medication consisting of non-dilute 2% lidocaine with epinephrine 1:100,000, and the other side will be injected using the treatment medication consisting of 2% lidocaine with epinephrine 1:100,000 diluted with normal saline (09.% NaCl) in a 1:4 ratio with normal saline (1 cc of anesthetic to 4 cc of normal saline). The distribution of which eyelid (right versus left) receives each arm will be randomized and hidden from both the researcher and the patient. Identical syringes and hypodermic needles will be used for the treatment and control arms. Each patient will then be asked to rate the pain experienced during local anesthetic injection for each side using a 100 mm visual analog scale (VAS). At the end of surgery, each patient will be asked to rate the level of pain experienced during the surgery on each side using a blank version of the same scale. Patients will be followed up for their regular post-operative appointment 7-21 days after surgery.

Data (VAS pain scores) will be collected on paper from each patient and entered into an Excel format spreadsheet. The need for additional local anesthetic, as well as the rate of anesthetic infiltration, will also be recorded in this Excel file. All data will be deidentified by assigning each participant an alphanumeric code.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients age 18 and older undergoing primary bilateral upper eyelid blepharoplasty
  • Consent and compliance with all aspects of the study protocol

Exclusion criteria

  • Patients undergoing two different types of surgery on either side (example, blepharoplasty on one side and ptosis repair on the other)
  • Patients under 18 years old
  • Patient scheduled for upper eyelid blepharoplasty who has had previous upper eyelid ptosis repair or upper eyelid blepharoplasty
  • Patient undergoing unilateral surgery
  • Active local or systemic malignancy
  • Concurrent inflammatory lesion of the upper eyelids
  • Participant is pregnant or plans to become pregnant during the treatment period
  • Participant is involved in a WorkSafe (worker's compensation), personal injury suit, or other legal matter related to their health

Treatment and study plan

Full strength lidocaine with epinephrine

Drug

2% lidocaine with epinephrine 1:100,000

Dilute lidocaine with epinephrine

Drug

2% lidocaine with epinephrine 1:100,000 diluted with normal saline (09.% NaCl) in a 1:4 ratio

Primary outcomes

  1. Pain during injection

    Time frame: Immediately after injection

    Each patient will be asked to rate the pain experienced during local anesthetic injection for each side using a 100 mm visual analog scale (VAS)

Secondary outcomes

  1. Pain during surgery

    Time frame: Immediately after surgery

    Each patient will be asked to rate the pain experienced during surgery for each side using a 100 mm visual analog scale (VAS)

Sponsors and collaborators

Lead sponsor

Timothy Ekhlassi

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 7, 2023
Registry last updated
Sep 20, 2024

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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