Trial Outcomes & Findings for Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia (NCT NCT04495868)
NCT ID: NCT04495868
Last Updated: 2023-04-18
Results Overview
Participants rated their pain level from the insertion of the needle for the lumbar medial branch block using the skin wheal created with each anesthetic. Pain is rated on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Day 1
Results posted on
2023-04-18
Participant Flow
Participant milestones
| Measure |
Bacteriostatic Normal Saline Then 1% Lidocaine
Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of bacteriostatic normal saline followed by an intradermal administration of 1% lidocaine.
Bacteriostatic Normal Saline: A skin wheal will be made with bacteriostatic normal saline (BNS). BNS contains 0.9% benzyl alcohol and benzyl alcohol is an opium alkaloid that is sometimes added to physiologic normal saline for its bacteriostatic properties. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.
1% Lidocaine: A skin wheal will be made with 1% lidocaine. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.
|
1% Lidocaine Then Bacteriostatic Normal Saline
Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of 1% lidocaine followed by an intradermal administration of bacteriostatic normal saline.
Bacteriostatic Normal Saline: A skin wheal will be made with bacteriostatic normal saline (BNS). BNS contains 0.9% benzyl alcohol and benzyl alcohol is an opium alkaloid that is sometimes added to physiologic normal saline for its bacteriostatic properties. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.
1% Lidocaine: A skin wheal will be made with 1% lidocaine. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
21
|
|
Overall Study
COMPLETED
|
19
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Bacteriostatic Normal Saline Then 1% Lidocaine
n=19 Participants
Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of bacteriostatic normal saline followed by an intradermal administration of 1% lidocaine.
|
1% Lidocaine Then Bacteriostatic Normal Saline
n=21 Participants
Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of 1% lidocaine followed by an intradermal administration of bacteriostatic normal saline.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=19 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=19 Participants
|
20 Participants
n=21 Participants
|
34 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=19 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=19 Participants
|
19 Participants
n=21 Participants
|
32 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=19 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 Participants
n=19 Participants
|
21 Participants
n=21 Participants
|
40 Participants
n=40 Participants
|
|
Numerical Pain Rating Scale (NPRS) Score of Back Pain
|
8 units on a scale
n=19 Participants
|
8 units on a scale
n=21 Participants
|
8 units on a scale
n=40 Participants
|
PRIMARY outcome
Timeframe: Day 1Participants rated their pain level from the insertion of the needle for the lumbar medial branch block using the skin wheal created with each anesthetic. Pain is rated on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.
Outcome measures
| Measure |
Bacteriostatic Normal Saline
n=40 Participants
Participants undergoing a lumbar medial branch block receiving an intradermal administration of bacteriostatic normal saline.
|
1% Lidocaine
n=40 Participants
Participants undergoing a lumbar medial branch block receiving an intradermal administration of 1% lidocaine.
|
|---|---|---|
|
Needle Placement Pain Score
|
0 units on a scale
Interval 0.0 to 1.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1Participants rated their pain level from the creation of the skin wheal using each anesthetic on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.
Outcome measures
| Measure |
Bacteriostatic Normal Saline
n=40 Participants
Participants undergoing a lumbar medial branch block receiving an intradermal administration of bacteriostatic normal saline.
|
1% Lidocaine
n=40 Participants
Participants undergoing a lumbar medial branch block receiving an intradermal administration of 1% lidocaine.
|
|---|---|---|
|
Skin Wheal Pain Score
|
5 units on a scale
Interval 2.0 to 7.0
|
6 units on a scale
Interval 4.0 to 9.0
|
Adverse Events
Bacteriostatic Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1% 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