Trial Outcomes & Findings for Comparison of Bacteriostatic Saline to Buffered Lidocaine for Ultrasound Guided Hip Joint Injection Local Anesthesia (NCT NCT02209272)

Results Overview

The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by "no pain" (score of 0) and "pain as bad as it could be" (score of 100).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

68 participants

Primary outcome timeframe

baseline to 5-10 minutes later -- immediately after local anesthetic injection administration

Results posted on

2019-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Bacteriostatic Saline In this arm patients received 2 injections: 1. one injection of bacteriostatic saline (0.9% benzyl alcohol) in the skin, subcutaneous tissue and muscle overlying the hip joint using a 25 gauge needle 2. a subsequent hip joint injection with corticosteroid and ropivacaine using a 22 gauge needle VAS-pain scores were collected immediately after each injection.	Buffered Lidocaine In this arm patients received 2 injections: 1. one injection of buffered 1% lidocaine in the skin, subcutaneous tissue and muscle overlying the hip joint using a 25 gauge needle 2. a subsequent hip joint injection with corticosteroid and ropivacaine using a 22 gauge needle VAS-pain scores were collected immediately after each injection.
Overall Study STARTED	32	36
Overall Study COMPLETED	32	36
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

Baseline characteristics by cohort
Measure	Bacteriostatic Saline n=32 Participants In this arm patients received 2 injections: 1. one injection of bacteriostatic saline (0.9% benzyl alcohol) in the skin, subcutaneous tissue and muscle overlying the hip joint using a 25 gauge needle 2. a subsequent hip joint injection with corticosteroid and ropivacaine using a 22 gauge needle VAS-pain scores were collected immediately after each injection.	Buffered Lidocaine n=36 Participants In this arm patients received 2 injections: 1. one injection of buffered 1% lidocaine in the skin, subcutaneous tissue and muscle overlying the hip joint using a 25 gauge needle 2. a subsequent hip joint injection with corticosteroid and ropivacaine using a 22 gauge needle VAS-pain scores were collected immediately after each injection.	Total n=68 Participants Total of all reporting groups
Age, Continuous	54.2 years STANDARD_DEVIATION 16 • n=32 Participants	55.6 years STANDARD_DEVIATION 16.1 • n=36 Participants	54.9 years STANDARD_DEVIATION 16 • n=68 Participants
Sex: Female, Male Female	17 Participants n=32 Participants	23 Participants n=36 Participants	40 Participants n=68 Participants
Sex: Female, Male Male	15 Participants n=32 Participants	13 Participants n=36 Participants	28 Participants n=68 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	32 Participants n=32 Participants	36 Participants n=36 Participants	68 Participants n=68 Participants

PRIMARY outcome

Timeframe: baseline to 5-10 minutes later -- immediately after local anesthetic injection administration

The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by "no pain" (score of 0) and "pain as bad as it could be" (score of 100).

Outcome measures

Outcome measures
Measure	Bacteriostatic Saline n=32 Participants for ultrasound guided hip joint injection local anesthesia bacteriostatic saline	Buffered Lidocaine n=36 Participants for ultrasound guided hip joint injection local anesthesia buffered lidocaine
VAS for Pain Score During Local Anesthesia Infiltration	13.2 score on a scale Standard Deviation 15	14 score on a scale Standard Deviation 13.5

SECONDARY outcome

Timeframe: baseline to 5-10 minutes later -- immediately after hip joint injection

The Visual Analog Scale (VAS) for Pain is a validated tool used to measure pain. A 100mm horizontal line anchored by "no pain" (score of 0) and "pain as bad as it could be" (score of 100).

Outcome measures

Outcome measures
Measure	Bacteriostatic Saline n=32 Participants for ultrasound guided hip joint injection local anesthesia bacteriostatic saline	Buffered Lidocaine n=36 Participants for ultrasound guided hip joint injection local anesthesia buffered lidocaine
VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy)	20.7 score on a scale Standard Deviation 18.4	15.6 score on a scale Standard Deviation 13.9

SECONDARY outcome

Timeframe: baseline

Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds.

Outcome measures

Outcome measures
Measure	Bacteriostatic Saline n=32 Participants for ultrasound guided hip joint injection local anesthesia bacteriostatic saline	Buffered Lidocaine n=36 Participants for ultrasound guided hip joint injection local anesthesia buffered lidocaine
Anesthetic Infiltration Duration	33.3 seconds Standard Deviation 4.5	32.7 seconds Standard Deviation 5

Adverse Events

Bacteriostatic Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Buffered 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

Dr. Jacob L. Sellon

Mayo Clinic

Phone: 507-284-2608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place