Trial Outcomes & Findings for Split Face Study of the Duration of Local Anesthetics (NCT NCT05767749)

Last Updated: 2024-09-19

Results Overview

To determine whether the time to return to baseline sensation differs significantly between each pair of anesthetics, the investigators will measure the time to return to baseline sensation at each anesthetized site by asking participants at 15 minute intervals if they can feel a sharp sensation at the site. Sterile needles will be used. The return of the sensitivity will be determined using binary outcomes (yes/no) and recorded on a standardized template. The maximum difference in anesthetic duration that the investigators consider "not different" from a clinical standpoint is 15 minutes.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

75 participants

Primary outcome timeframe

Up to 4 hours.

Results posted on

2024-09-19

Participant Flow

75 subjects were recruited from March to July, 2023 at one site.

Unit of analysis: nasal ala

Participant milestones

Participant milestones
Measure	Lidocaine+Epinephrine (vs Ropivacaine) Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) (compared to 0.5ml of Naropin (ropivacaine) 0.5% into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: lidocaine + epinephrine 1:100,000: 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.	Ropivacaine (vs Lidocaine+Epinephrine) Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Naropin (ropivacaine) 0.5% into one side of the nose (nasal ala) (compared to 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: Ropivacaine 0.5% Injectable Solution: 0.5 ml Ropivacaine 0.5% Injectable Solution	Lidocaine+Epinephrine (vs Bupivacaine) Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) (compared to 0.5ml bupivacaine 0.5% into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: lidocaine + epinephrine 1:100,000: 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.	Bupivacaine (vs Lidocaine+Epinephrine) Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml bupivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: Bupivacaine 0.5% Injectable Solution: 0.5ml bupivacaine 0.5%	Ropivacaine (vs Bupivacaine) Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5 ml Ropivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5ml bupivacaine 0.5% into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: Ropivacaine 0.5% Injectable Solution: 0.5 ml Ropivacaine 0.5% Injectable Solution	Bupivacaine (vs Ropivacaine) Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml bupivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5 ml Ropivacaine 0.5% into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: Bupivacaine 0.5% Injectable Solution: 0.5ml bupivacaine 0.5%
Overall Study STARTED	24 24	24 24	25 25	25 25	26 26	26 26
Overall Study COMPLETED	24 24	24 24	23 23	23 23	24 24	24 24
Overall Study NOT COMPLETED	0 0	0 0	2 2	2 2	2 2	2 2

Reasons for withdrawal

Reasons for withdrawal
Measure	Lidocaine+Epinephrine (vs Ropivacaine) Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) (compared to 0.5ml of Naropin (ropivacaine) 0.5% into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: lidocaine + epinephrine 1:100,000: 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.	Ropivacaine (vs Lidocaine+Epinephrine) Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Naropin (ropivacaine) 0.5% into one side of the nose (nasal ala) (compared to 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: Ropivacaine 0.5% Injectable Solution: 0.5 ml Ropivacaine 0.5% Injectable Solution	Lidocaine+Epinephrine (vs Bupivacaine) Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) (compared to 0.5ml bupivacaine 0.5% into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: lidocaine + epinephrine 1:100,000: 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.	Bupivacaine (vs Lidocaine+Epinephrine) Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml bupivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: Bupivacaine 0.5% Injectable Solution: 0.5ml bupivacaine 0.5%	Ropivacaine (vs Bupivacaine) Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5 ml Ropivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5ml bupivacaine 0.5% into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: Ropivacaine 0.5% Injectable Solution: 0.5 ml Ropivacaine 0.5% Injectable Solution	Bupivacaine (vs Ropivacaine) Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml bupivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5 ml Ropivacaine 0.5% into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: Bupivacaine 0.5% Injectable Solution: 0.5ml bupivacaine 0.5%
Overall Study Withdrawal by Subject	0	0	2	2	2	2

Baseline Characteristics

Split Face Study of the Duration of Local Anesthetics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine+Epinephrine (vs Ropivacaine) n=23 nasal ala Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) (compared to 0.5ml of Naropin (ropivacaine) 0.5% into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: lidocaine + epinephrine 1:100,000: 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.	Ropivacaine (vs Lidocaine+Epinephrine) n=23 nasal ala Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Naropin (ropivacaine) 0.5% into one side of the nose (nasal ala) (compared to 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: Ropivacaine 0.5% Injectable Solution: 0.5 ml Ropivacaine 0.5% Injectable Solution	Lidocaine+Epinephrine (vs Bupivacaine) n=23 nasal ala Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into one side of the nose (nasal ala) (compared to 0.5ml bupivacaine 0.5% into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: lidocaine + epinephrine 1:100,000: 0.5 ml lidocaine + epinephrine 1:100,000, buffered 1/10 with sodium bicarb.	Bupivacaine (vs Lidocaine+Epinephrine) n=23 nasal ala Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml bupivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5ml of Xylocaine + epinephrine 1:100,000 (lidocaine + epinephrine 1:100,000), buffered 1/10 with sodium bicarb into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: Bupivacaine 0.5% Injectable Solution: 0.5ml bupivacaine 0.5%	Ropivacaine (vs Bupivacaine) n=24 nasal ala Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5 ml Ropivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5ml bupivacaine 0.5% into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: Ropivacaine 0.5% Injectable Solution: 0.5 ml Ropivacaine 0.5% Injectable Solution	Bupivacaine (vs Ropivacaine) n=24 nasal ala Each site of the nasal ala will be tested for normal sensation using sterile 30-gauge needles. Other eligibility criteria will be confirmed. Participants in this arm will receive an injection of 0.5ml bupivacaine 0.5% into one side of the nose (nasal ala) (compared to 0.5 ml Ropivacaine 0.5% into the opposite nasal ala). Laterality of each anesthetic administration will be randomly assigned for each patient. Subjects will be evaluated for duration of effect of anesthesia every 15 minutes , until the patient reports return of a sharp sensation upon the pinprick test. Agent: Bupivacaine 0.5% Injectable Solution: 0.5ml bupivacaine 0.5%	Total n=140 nasal ala Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	44 Participants n=8 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants	19 Participants n=4 Participants	20 Participants n=21 Participants	20 Participants n=8 Participants	106 Participants n=8 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=8 Participants	54 Participants n=8 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	17 Participants n=5 Participants	17 Participants n=4 Participants	16 Participants n=21 Participants	16 Participants n=8 Participants	96 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	24 Participants n=7 Participants	23 Participants n=5 Participants	23 Participants n=4 Participants	24 Participants n=21 Participants	24 Participants n=8 Participants	142 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	22 Participants n=4 Participants	23 Participants n=21 Participants	23 Participants n=8 Participants	134 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	8 Participants n=8 Participants

PRIMARY outcome

Timeframe: Up to 4 hours.

Population: Participants were excluded from analysis if they withdrew from the study (1 participant), did not regain sensation bilaterally before leaving the study site (3 participants), or, if the time to regain sensation could not be accurately determined (1 participant).