Hip Dysplasia, Femoroacetabular Impingement, Acetabular Labrum Tear
Conditions
Keywords
Hip Arthroscopy
Brief summary
Patients undergoing a hip scope procedure will be recruited for this study. They will be randomized to either receive a nerve block or no nerve block (pain medicine only). Pain levels and clinical outcomes will be assessed through 3 months post-operatively.
Interventions
Sponsors
The Hawkins Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for outpatient hip arthroscopy * American Society of Anesthesiologists (ASA) 1-3
Exclusion criteria
* Prior surgery on ipsilateral hip * ASA 4-6 * Chronic narcotic usage over 6 months or more than the equivalent of 20mg of morphine per day * Current or prior placement of a spinal cord stimulator or intrathecal pump for pain control purposes * Allergy to amide local anesthetics * Contraindication to regional anesthesia * BMI \> 40 * Females who are pregnant or plan to get pregnant during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | 3 Months | Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption | 3 Months | Opioid consumption, as measured by narcotic usage (morphine milligram equivalents) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time in PACU | Duration of PACU stay in minutes from end of surgery to discharge from PACA | Measured time subjects spent in the post anesthesia care unit. |
| Total Number of Episodes of Nausea and Vomiting | From end of surgery to discharge from PACU | Occurrences of periods of nausea and vomiting |
| Hospital Readmission | 3 months | Number of participants that were readmitted to the hospital |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FI Block Fascia iliaca block consisting of up to 60 mL of 0.35% ropivicaine at a dose of 3 mg/kg (with adjuvants of 100 mcg clonidine \[per 60 mL\] and epinephrine 1:400,000)
ropivicaine
clonidine
Epinephrine | 41 |
| Local Injection Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin
Noropin | 43 |
| Total | 84 |
Baseline characteristics
| Characteristic | Total | FI Block | Local Injection |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants | 41 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants | 40 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 74 Participants | 37 Participants | 37 Participants |
| Region of Enrollment United States | 84 participants | 41 participants | 43 participants |
| Sex: Female, Male Female | 56 Participants | 26 Participants | 30 Participants |
| Sex: Female, Male Male | 28 Participants | 15 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 43 |
| other Total, other adverse events | 1 / 41 | 1 / 43 |
| serious Total, serious adverse events | 0 / 41 | 0 / 43 |
Outcome results
Primary
Visual Analog Scale
Pain, as measured by Visual Analog Scale (VAS). Scores are ranged from 0-10, 0 is no pain and 10 is worst possible pain. The unit of measure is units on a scale.
Time frame: 3 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FI Block | Visual Analog Scale | 2.65 units on a scale |
| Local Injection | Visual Analog Scale | 2.50 units on a scale |
Secondary
Opioid Consumption
Opioid consumption, as measured by narcotic usage (morphine milligram equivalents)
Time frame: 3 Months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FI Block | Opioid Consumption | 26.87 morphine milligram equivalents |
| Local Injection | Opioid Consumption | 30.32 morphine milligram equivalents |
Other Pre-specified
Hospital Readmission
Number of participants that were readmitted to the hospital
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FI Block | Hospital Readmission | 1 Participants |
| Local Injection | Hospital Readmission | 2 Participants |
Other Pre-specified
Time in PACU
Measured time subjects spent in the post anesthesia care unit.
Time frame: Duration of PACU stay in minutes from end of surgery to discharge from PACA
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FI Block | Time in PACU | 150.04 Minutes |
| Local Injection | Time in PACU | 151.59 Minutes |
Other Pre-specified
Total Number of Episodes of Nausea and Vomiting
Occurrences of periods of nausea and vomiting
Time frame: From end of surgery to discharge from PACU
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FI Block | Total Number of Episodes of Nausea and Vomiting | 11 Number of episodes |
| Local Injection | Total Number of Episodes of Nausea and Vomiting | 7 Number of episodes |