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

NCT06121141 | Completed Phase 4 FDA Drug

• 1 other identifier: Thesis001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dermatochalasis; Dermatochalasis of Eyelid; Dermatochalasis of Both Upper Eyelids; Dermatochalasis of Both Eyes; Dermatochalasis of Right Upper Eyelid; Dermatochalasis of Left Upper Eyelid; Pain

Keywords

Dermatochalasis; Oculoplastic surgery; Eyelid surgery; Blepharoplasty; Upper blepharoplasty; Upper eyelid blepharoplasty

Outcome Measures

Primary Outcomes (1)

• Pain during 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)

  Immediately after injection

Secondary Outcomes (1)

• Pain during surgery

  Immediately after surgery

Study Arms (2)

Control

ACTIVE COMPARATOR

Full-strength lidocaine with epinephrine

Drug: Full strength lidocaine with epinephrine

Experimental

EXPERIMENTAL

Dilute lidocaine with epinephrine

Drug: Dilute lidocaine with epinephrine

Interventions

Full strength lidocaine with epinephrine DRUG

2% lidocaine with epinephrine 1:100,000

Control

Dilute lidocaine with epinephrine DRUG

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Timothy Ekhlassi: lead

Study Sites (1)

Fraser Valley Cataract and Laser

Surrey, British Columbia, V3S5K7, Canada

Location

MeSH Terms

Conditions

Cutis Laxa; Pain

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Timothy Ekhlassi, MD

  Fraser Valley Cataract and Laser

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: November 2, 2023
• First Posted: November 7, 2023
• Study Start: August 7, 2023
• Primary Completion: January 23, 2024
• Study Completion: May 27, 2024
• Last Updated: September 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)