Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06121141
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-11-02
Brief Title:
Comparison of Two Different Concentrations of Local Anesthetic in Patient Reported Pain in Oculoplastic Surgery
Sponsor:
Timothy Ekhlassi
Organization:
Ekhlassi Timothy MD
Study Overview
Official Title:
Comparison of Two Different Concentrations of Local Anesthetic in Patient Reported Pain in Oculoplastic Surgery
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 1100000 and the other side will be injected using the treatment medication consisting of 2 lidocaine with epinephrine 1100000 diluted with normal saline 09 NaCl in a 14 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
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 1100000 and the other side will be injected using the treatment medication consisting of 2 lidocaine with epinephrine 1100000 diluted with normal saline 09 NaCl in a 14 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None