Trial Outcomes & Findings for Clinical Study to Evaluate the Effect of pH on Pain Upon Local Anesthetic Administration. (NCT NCT01304082)
NCT ID: NCT01304082
Last Updated: 2017-04-11
Results Overview
Pain score upon injection of local anesthetic: the pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
immediate, upon injection of each solution
Results posted on
2017-04-11
Participant Flow
Participant milestones
| Measure |
C, L, A
control, lidocaine, alkalinized lidocaine
|
C, A, L
control, alkalinized lidocaine, lidocaine
|
L, C, A
lidocaine, control, alkalinized lidocaine
|
A, C, L
alkalinized lidocaine, control, lidocaine
|
A, L, C
alkalinized lidocaine, lidocaine, control
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
2
|
11
|
8
|
5
|
|
Overall Study
First Intervention
|
3
|
2
|
11
|
8
|
5
|
|
Overall Study
Second Intervention
|
3
|
2
|
11
|
8
|
5
|
|
Overall Study
Third Intervention
|
3
|
2
|
11
|
8
|
5
|
|
Overall Study
COMPLETED
|
3
|
2
|
11
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant was missing age.
Baseline characteristics by cohort
| Measure |
All Study Participants
n=29 Participants
All study participants
|
|---|---|
|
Age, Continuous
|
54.5 years
n=28 Participants • One participant was missing age.
|
|
Sex: Female, Male
Female
|
13 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=29 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=29 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=29 Participants
|
|
Baseline Pain Score
|
6 units on a scale
n=29 Participants
|
PRIMARY outcome
Timeframe: immediate, upon injection of each solutionPain score upon injection of local anesthetic: the pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable).
Outcome measures
| Measure |
Normal Saline
n=29 Participants
normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
|
Lidocaine
n=29 Participants
Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
|
Alkalinized Lidocaine
n=29 Participants
alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
|
|---|---|---|---|
|
Rank-transformed Pain Score
Rank-transformed pain score
|
1.97 rank
Interval 1.62 to 2.31
|
2.10 rank
Interval 1.76 to 2.45
|
1.93 rank
Interval 1.59 to 2.27
|
|
Rank-transformed Pain Score
Difference compared to control
|
0 rank
Interval 0.0 to 0.0
|
0.138 rank
Interval -0.459 to 0.735
|
-0.034 rank
Interval -0.632 to 0.563
|
|
Rank-transformed Pain Score
Difference compared to lidocaine
|
-0.138 rank
Interval -0.735 to 0.459
|
0 rank
Interval 0.0 to 0.0
|
-0.172 rank
Interval -0.769 to 0.425
|
SECONDARY outcome
Timeframe: 0-180 seconds after each injection.Rank-transformed time (seconds) until hypoesthesia will be assessed using a sensory stimulus
Outcome measures
| Measure |
Normal Saline
n=29 Participants
normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
|
Lidocaine
n=29 Participants
Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
|
Alkalinized Lidocaine
n=29 Participants
alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
|
|---|---|---|---|
|
Rank-transformed Time (Seconds) Until Hypoesthesia
Rank-transformed time (s)
|
2.95 rank
Interval 2.75 to 3.15
|
1.47 rank
Interval 1.27 to 1.67
|
1.59 rank
Interval 1.39 to 1.79
|
|
Rank-transformed Time (Seconds) Until Hypoesthesia
Difference compared to control
|
0 rank
Interval 0.0 to 0.0
|
-1.48 rank
Interval -1.83 to -1.13
|
-1.36 rank
Interval -1.71 to -1.01
|
|
Rank-transformed Time (Seconds) Until Hypoesthesia
Difference compared to lidocaine
|
1.48 rank
Interval 1.13 to 1.83
|
0 rank
Interval 0.0 to 0.0
|
0.121 rank
Interval -0.228 to 0.469
|
SECONDARY outcome
Timeframe: 0-180 seconds after each injectionRank-transformed time (seconds) until anesthesia will be assessed using a repeated sensory stimulus.
Outcome measures
| Measure |
Normal Saline
n=29 Participants
normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
|
Lidocaine
n=29 Participants
Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
|
Alkalinized Lidocaine
n=29 Participants
alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
|
|---|---|---|---|
|
Rank-transformed Time (Seconds) Until Anesthesia
Difference compared to control
|
0 rank
Interval 0.0 to 0.0
|
-1.28 rank
Interval -1.66 to -0.9
|
-1.41 rank
Interval -1.79 to -1.03
|
|
Rank-transformed Time (Seconds) Until Anesthesia
Rank-transformed time (s)
|
2.90 rank
Interval 2.68 to 3.11
|
1.62 rank
Interval 1.4 to 1.84
|
1.48 rank
Interval 1.26 to 1.7
|
|
Rank-transformed Time (Seconds) Until Anesthesia
Difference compared to lidocaine
|
1.28 rank
Interval 0.9 to 1.66
|
0 rank
Interval 0.0 to 0.0
|
-0.14 rank
Interval -0.52 to 0.24
|
SECONDARY outcome
Timeframe: 1 minute after each injectionPain score upon needle stick: The pain score is a validated 11-point numeric rating scale in which patients rate pain between 0 (no pain) and 10 (worst pain imaginable).
Outcome measures
| Measure |
Normal Saline
n=29 Participants
normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
|
Lidocaine
n=29 Participants
Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
|
Alkalinized Lidocaine
n=29 Participants
alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
|
|---|---|---|---|
|
Rank-transformed Pain Score Upon Needle Stick.
Rank-transformed pain score
|
2.72 rank
Interval 2.5 to 2.95
|
1.64 rank
Interval 1.41 to 1.86
|
1.64 rank
Interval 1.41 to 1.86
|
|
Rank-transformed Pain Score Upon Needle Stick.
Difference compared to control
|
0 rank
Interval 0.0 to 0.0
|
-1.09 rank
Interval -1.48 to -0.7
|
-1.09 rank
Interval -1.48 to -0.7
|
|
Rank-transformed Pain Score Upon Needle Stick.
Difference compared to lidocaine
|
1.09 rank
Interval 0.7 to 1.48
|
0 rank
Interval 0.0 to 0.0
|
0 rank
Interval -0.39 to 0.39
|
Adverse Events
Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alkalinized Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place