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

September 19, 2024 updated by: Timothy Ekhlassi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3S5K7
        • Fraser Valley Cataract and Laser

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Full-strength lidocaine with epinephrine
Drug: Full strength lidocaine with epinephrine
2% lidocaine with epinephrine 1:100,000
Experimental: Experimental
Dilute lidocaine with epinephrine
Drug: Dilute lidocaine with epinephrine
2% lidocaine with epinephrine 1:100,000 diluted with normal saline (09.% NaCl) in a 1:4 ratio

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Immediately after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Immediately after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Timothy Ekhlassi

Investigators

  • Principal Investigator: Timothy Ekhlassi, MD, Fraser Valley Cataract and Laser

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2023

Primary Completion (Actual)

January 23, 2024

Study Completion (Actual)

May 27, 2024

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 20, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Thesis001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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