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

Sponsor

Timothy Ekhlassi (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06121141

Collaborator

(none)

Enrollment

Location

Arms

6.7

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dermatochalasis Dermatochalasis of Eyelid Dermatochalasis of Both Upper Eyelids Dermatochalasis of Both Eyes Dermatochalasis of Right Upper Eyelid Dermatochalasis of Left Upper Eyelid Pain	Drug: Full strength lidocaine with epinephrine Drug: Dilute lidocaine with epinephrine	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 7, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain during injection [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 Outcome Measures

Pain during surgery [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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