Hip Pain
Conditions
Brief summary
The purpose of this study is to compare infiltration pain and anesthetic efficacy between lidocaine and Bacteriostatic saline (BS) for ultrasound (US) guided intraarticular hip injections.
Detailed description
Local anesthesia is commonly used to reduce pain during joint injections, particularly for deep joints like the hip. Lidocaine is the most commonly used local anesthetic in most medical practices. It is well known that lidocaine infiltration itself is painful. Many strategies have been studied to minimize pain associated with lidocaine administration, including buffering, warming, and slowing infiltration rate. BS is an alternative local anesthetic that has been shown to be less painful when injected into subcutaneous tissues compared with lidocaine. However, BS use has not been widely implemented for local anesthesia, and it has not been studied in the context of joint injections.
Interventions
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* age 18-75 years * referred for US-guided intraarticular hip injections in the Mayo Clinic Sports Medicine Center, Physical Medicine & Rehabilitation Clinic, or Musculoskeletal Clinic
Exclusion criteria
* chronic opioid use * opioid use on day of procedure * history of fibromyalgia or other diffuse chronic pain syndrome * pain behavior during the clinical encounter as judged by the injectionist * anesthetic administration time outside the designated 5-15 second time frame
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS for Pain Score During Local Anesthesia Infiltration | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy) | 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). |
| Anesthetic Infiltration Duration | baseline | Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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. | 36 |
| Total | 68 |
Baseline characteristics
| Characteristic | Buffered Lidocaine | Total | Bacteriostatic Saline |
|---|---|---|---|
| Age, Continuous | 55.6 years STANDARD_DEVIATION 16.1 | 54.9 years STANDARD_DEVIATION 16 | 54.2 years STANDARD_DEVIATION 16 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 36 Participants | 68 Participants | 32 Participants |
| Sex: Female, Male Female | 23 Participants | 40 Participants | 17 Participants |
| Sex: Female, Male Male | 13 Participants | 28 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 36 |
| other Total, other adverse events | 0 / 32 | 0 / 36 |
| serious Total, serious adverse events | 0 / 32 | 0 / 36 |
Outcome results
Primary
VAS for Pain Score During Local Anesthesia Infiltration
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).
Time frame: baseline to 5-10 minutes later -- immediately after local anesthetic injection administration
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bacteriostatic Saline | VAS for Pain Score During Local Anesthesia Infiltration | 13.2 score on a scale | Standard Deviation 15 |
| Buffered Lidocaine | VAS for Pain Score During Local Anesthesia Infiltration | 14 score on a scale | Standard Deviation 13.5 |
p-value: 0.82t-test, 2 sided
Secondary
Anesthetic Infiltration Duration
Anesthetic infiltration duration will be measured using a timer on the ultrasound machine, with goal administration between 20-40 seconds.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bacteriostatic Saline | Anesthetic Infiltration Duration | 33.3 seconds | Standard Deviation 4.5 |
| Buffered Lidocaine | Anesthetic Infiltration Duration | 32.7 seconds | Standard Deviation 5 |
p-value: 0.57t-test, 2 sided
Secondary
VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy)
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).
Time frame: baseline to 5-10 minutes later -- immediately after hip joint injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bacteriostatic Saline | VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy) | 20.7 score on a scale | Standard Deviation 18.4 |
| Buffered Lidocaine | VAS for Pain Score During Subsequent Hip Joint Injection (Local Anesthetic Efficacy) | 15.6 score on a scale | Standard Deviation 13.9 |
p-value: 0.21t-test, 2 sided