Trial Outcomes & Findings for Reducing Pain of Lidocaine Injection (NCT NCT02288364)

Results Overview

Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

88 participants

Primary outcome timeframe

immediately prior to anesthetizing, within approximately 1 minute of starting

Results posted on

2016-04-15

Participant Flow

88 participants signed consent. 86 participants were randomized.

Participant milestones

Participant milestones
Measure	1% Lidocaine 1% Lidocaine alone.	1% Lidocaine Plus Sodium Bicarbonate 1% Lidocaine plus 8.4% sodium bicarbonate
Overall Study STARTED	42	44
Overall Study COMPLETED	42	44
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Pain of Lidocaine Injection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1% Lidocaine n=42 Participants 1% Lidocaine alone.	1% Lidocaine Plus Sodium Bicarbonate n=44 Participants 1% Lidocaine plus 8.4% sodium bicarbonate	Total n=86 Participants Total of all reporting groups
Age, Continuous	53.26 years STANDARD_DEVIATION 13.70 • n=5 Participants	53.80 years STANDARD_DEVIATION 13.22 • n=7 Participants	53.53 years STANDARD_DEVIATION 13.38 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	44 Participants n=7 Participants	86 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	28 participants n=5 Participants	31 participants n=7 Participants	59 participants n=5 Participants
Race/Ethnicity, Customized Black	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants
Race/Ethnicity, Customized Asian	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	44 participants n=7 Participants	86 participants n=5 Participants

PRIMARY outcome

Timeframe: immediately prior to anesthetizing, within approximately 1 minute of starting

Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.

Outcome measures

Outcome measures
Measure	1% Lidocaine n=42 Participants 1% Lidocaine alone.	1% Lidocaine Plus Sodium Bicarbonate n=44 Participants 1% Lidocaine plus 8.4% sodium bicarbonate
Pain	1.19 units on a scale Standard Deviation 1.92	0.56 units on a scale Standard Deviation 1.30

SECONDARY outcome

Timeframe: immediately on completion of anesthetizing the skin, within approximately 1 minute of starting

Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.

Outcome measures

Outcome measures
Measure	1% Lidocaine n=42 Participants 1% Lidocaine alone.	1% Lidocaine Plus Sodium Bicarbonate n=44 Participants 1% Lidocaine plus 8.4% sodium bicarbonate
Pain	2.07 units on a scale Standard Deviation 2.05	1.61 units on a scale Standard Deviation 1.99

SECONDARY outcome

Timeframe: immediately on completion of anesthetizing the parenchyma (deeper breast tissue), within approximately 4 minutes of starting

Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.

Outcome measures

Outcome measures
Measure	1% Lidocaine n=42 Participants 1% Lidocaine alone.	1% Lidocaine Plus Sodium Bicarbonate n=44 Participants 1% Lidocaine plus 8.4% sodium bicarbonate
Pain	2.98 units on a scale Standard Deviation 2.67	2.02 units on a scale Standard Deviation 2.37

SECONDARY outcome

Timeframe: immediately on completion of the biopsy, within approximately 20 minutes of starting

Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.

Outcome measures

Outcome measures
Measure	1% Lidocaine n=42 Participants 1% Lidocaine alone.	1% Lidocaine Plus Sodium Bicarbonate n=44 Participants 1% Lidocaine plus 8.4% sodium bicarbonate
Pain	1.45 units on a scale Standard Deviation 2.65	0.91 units on a scale Standard Deviation 2.06

SECONDARY outcome

Timeframe: 30 seconds after initiating superficial injection in the subcutaneous tissue, within approximately 1 minute of starting

Population: Data not collected at this time point.

Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: immediately prior to injection of "deep" anesthesia in the breast parenchyma, within approximately 4 minutes of starting

Population: Data not collected at this time point.

Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 seconds after initiating deep injection of the parenchyma (deeper breast tissue), within approximately 4 minutes of starting

Population: Data not collected at this time point.

Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: immediately prior to obtaining the first core biopsy specimen, within approximately 15 minutes of starting

Population: Data not collected at this time point.

Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: immediately after obtaining the first core biopsy specimen, within approximately 15 minutes of starting

Population: Data not collected at this time point.

Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: immediately on completion of the final core biopsy specimen, within approximately 20 minutes of starting

Population: Data not collected at this time point.

Measure of pain on a scale of 0-10. Zero would indicate no pain while a score of 10 would be the worse pain possible.

Outcome measures

Outcome data not reported

Adverse Events

1% Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

1% Lidocaine Plus Sodium Bicarbonate

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

Jay A. Baker, MD

Duke University Medical Center

Phone: 919-684-7645

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place