Trial Outcomes & Findings for The Efficacy of Local Anesthetics to Reduce Shoulder Pain Post-Steroid Injections (NCT NCT02592629)

Last Updated: 2018-10-16

Results Overview

Pain assessed on a visual analog scale from 1 (no pain) to 10 (worst pain imaginable). Pain score at 10 minutes post-injection is subtracted from baseline pre-injection score. Positive numbers to represent increases and negative numbers to represent decreases.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

change from baseline assessment before injection at 10 minutes post injection

Results posted on

2018-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	no Topical or Subcutaneous Anesthetic Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection	Subcutaneous Lidocaine Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection	Topical Ethyl Chloride Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection ethyl chloride: topical spray Kenalog: used with lidocaine in shoulder injection
Overall Study STARTED	5	9	5
Overall Study COMPLETED	5	9	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	no Topical or Subcutaneous Anesthetic n=5 Participants Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection	Subcutaneous Lidocaine n=9 Participants Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection	Topical Ethyl Chloride n=5 Participants Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection ethyl chloride: topical spray Kenalog: used with lidocaine in shoulder injection	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=9 Participants	0 Participants n=5 Participants	0 Participants n=19 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	9 Participants n=9 Participants	5 Participants n=5 Participants	19 Participants n=19 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=9 Participants	0 Participants n=5 Participants	0 Participants n=19 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	7 Participants n=9 Participants	2 Participants n=5 Participants	12 Participants n=19 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=9 Participants	3 Participants n=5 Participants	7 Participants n=19 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 Participants n=5 Participants	9 Participants n=9 Participants	5 Participants n=5 Participants	19 Participants n=19 Participants
baseline pain	4.2 units on a scale STANDARD_DEVIATION 2.56 • n=5 Participants	5.16 units on a scale STANDARD_DEVIATION 1.93 • n=9 Participants	4.7 units on a scale STANDARD_DEVIATION 1.84 • n=5 Participants	4.78 units on a scale STANDARD_DEVIATION 2.11 • n=19 Participants

PRIMARY outcome

Timeframe: change from baseline assessment before injection at 10 minutes post injection

Outcome measures

Outcome measures
Measure	no Topical or Subcutaneous Anesthetic n=5 Participants Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection	Subcutaneous Lidocaine n=9 Participants Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after 2 ml or 1% lidocaine by subcutaneous injection lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection Kenalog: used with lidocaine in shoulder injection	Topical Ethyl Chloride n=5 Participants Injection of 1 ml of 40 mg Kenalog combined with 4 ml of 1% lidocaine after applying ethyl chloride spray for 3 seconds lidocaine: used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection ethyl chloride: topical spray Kenalog: used with lidocaine in shoulder injection
Change in Pain Assessment	3 units on a scale Standard Deviation 1.6	4.21 units on a scale Standard Deviation 2.19	5.6 units on a scale Standard Deviation 1.88

Adverse Events

no Topical or Subcutaneous Anesthetic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Subcutaneous Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Topical Ethyl Chloride

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

Robert Gallo, M.D.

Penn State Hershey Medical Center

Phone: 7175310003

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place