Acetabular Labrum Tear, Internal Derangement of Hip
Conditions
Keywords
Hip Arthroscopy, Regional Anesthesia, Peripheral Nerve block
Brief summary
The goal of the study is to evaluate via a prospective, blinded, randomized clinical trial, whether ultrasound-guided single femoral and lateral femoral cutaneous nerve blocks with ropivacaine 0.5% with epinephrine (1:200,000) as a tracer for intravascular injection (total 30 ml) vs. saline with epinephrine (1:200,000) (total 30 ml), given just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain (NRS scores), postoperative opiate consumption, and time to discharge from the postanesthesia care unit. Differences between groups with respect to postoperative quality of life and functional scores will also be evaluated.
Detailed description
The purpose of this study is to evaluate whether ultrasound (using sound waves to produce an image)-guided regional anesthesia (local numbing medicine) to the hip area given in addition to general anesthesia just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain, and time to discharge from the post anesthesia care unit. In addition, the study aims to examine whether this regional anesthesia medication has any effect on the study subjects' use of pain medication both during and after the procedure, return to function, and quality of life in the 6 month period after the surgical procedure. Although hip arthroscopy is a routine procedure, the best method for pain control is not well established, and is the purpose of this study.
Interventions
DRUGRopivacaine
Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)
DRUGPlacebo
Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)
Sponsors
Rush University Medical Center
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 No maximum
Healthy volunteers
No
Inclusion criteria
* \>18 year old, * ASA physical status classification system score (ASA) \<=3 * due to undergo elective unilateral hip arthroscopy by one surgeon Dr. Nho (Co-Principal Investigator)
Exclusion criteria
* ASA physical status classification system score) (ASA) \>3 * history of opioid dependence or abuse * current chronic analgesic therapy (daily use =\>20 mg oxycodone-equivalent opioid use within 2 weeks before surgery and duration of use \>=4 weeks) * allergy to study medications (fentanyl and ropivicaine) * any neuromuscular deficit of the ipsilateral femoral nerve or quadriceps femoris muscle (including diabetic peripheral neuropathy) * diagnosis of hypertension and/or current treatment for hypertension * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Numerical Rating Scale Score (NRS 0-10) | Preoperative 2-8 wks | The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) Scores | Preoperative 2-8 wks | Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits. |
| Veterans RAND 12 Item Health Survey (VR-12) Scores | 3 months postoperative | Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Grp 1 Ropivacaine Block Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)
Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml) | 0 |
| Grp 2 Placebo Block Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)
Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml) | 0 |
| Total | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Pain Numerical Rating Scale Score (NRS 0-10)
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Time frame: Preoperative 2-8 wks
Population: Study was closed due to enrollment issues and data were not collected or analyzed.
Primary
Pain Numerical Rating Scale Score (NRS 0-10)
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Time frame: 6 months postoperative
Population: Study was closed due to enrollment issues and data were not collected or analyzed.
Primary
Pain Numerical Rating Scale Score (NRS 0-10)
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure. Study was closed due to enrollment issues and data were not collected or analized.
Time frame: 3 wks postoperative
Population: Study was closed due to enrollment issues and data were not collected or analized.
Primary
Pain Numerical Rating Scale Score (NRS 0-10)
The primary outcome measure will be pain scores at rest (NRS 0-10). Those scores will be documented at initial visit prior to surgery, and at postoperative office visits at 3 weeks, 3 months and 6 months post-procedure.
Time frame: 3 months postoperative
Population: Study was closed due to enrollment issues and data were not collected or analyzed.
Secondary
Veterans RAND 12 Item Health Survey (VR-12) Scores
Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.
Time frame: 3 months postoperative
Population: Study was closed due to enrollment issues and data were not collected or analyzed.
Secondary
Veterans RAND 12 Item Health Survey (VR-12) Scores
Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.
Time frame: 6 months postoperative
Population: Study was closed due to enrollment issues and data were not collected or analyzed.
Secondary
Veterans Research and Development (RAND) 12 Item Health Survey (VR-12) Scores
Preoperative VR-12 scores will be compared with the VR-12 scores obtained at the 3 mo and 6 mo postoperative visits.
Time frame: Preoperative 2-8 wks
Population: Study was closed due to enrollment issues and data were not collected or analyzed.