Effectiveness of Fascia Iliaca Nerve Block for Post Hip Arthroscopy

This study will be a randomized, double-blinded, placebo controlled study. All patients who
are scheduled to undergo a hip arthroscopy with Dr. Yen who meet the inclusion/exclusion
criteria will be approached and informed consent and assent when indicated would be
obtained.Attending surgeon, anesthesia care team, PACU nursing staff, inpatient ward nursing
staff and evaluators will be blinded to study group. Regional Anesthesia team and pharmacy
staff will be not blinded to assignment of patient group but will have no additional contact
with patient after provision of sham or actual perineural catheter. the study design will be
real catheter versus a sham catheter, or control. All subjects will receive general
anesthesia. The catheters (real or sham) will be administered after the induction of general
anesthesia and before the beginning of the surgery until 24 hours after recorded PACU
admittance time. The anesthesia team placing the block will not be blinded. The orthopaedic
surgeon (Dr. Yen) and all evaluators will be blinded to the absence or presence of a real
catheter. In the case of a sham catheter, the anesthesia team will rig a pump to look like it
is dispensing local anesthesia.

1. General Anesthesia a) Induction (IV): i. propofol: 2-4 mg/kg [9] ii. fentanyl: 2 mcg/kg
administered iii. decadron: 4 mg as an antiemetic b) Airway: i. Airway management will
be chosen by the anesthesiologist in charge of the case.

c) Maintenance of anesthesia i. Sevoflurane 1.1 minimum alveolar concentration (MAC) ii.
If heart rate or blood pressure increase > 20% above baseline (tachycardia as determined
the morning of surgery in the holding area), anesthesiologist will administer1
microgram/kg fentanyl as bolus. May repeat as often as every 10 minutes. Maximum 8
doses.

iii. With patient movement, anesthesiologist will administer propofol 1 mg/kg
intravenous push. May repeat every 5 minutes as necessary.

d) Emergence i. Discontinue isoflurane ii. Zofran 4 mg IV iii. Ketorolac 0.5 mg/kg IV;
max dose 30 mg.

2. Perineural Catheter:

- Actual and sham will be hooked to infusion pump and receptacle

- Pharmacy will label the infusion pumps, and will cover these labels in such a way
that the cover can be immediately at any point if needed.

- Regional anesthesia team will double check the correct direction of the stopcock of
the tubing set.

a) Drug Group: i. Fascia Iliaca Catheter placement

1. Administrator: Regional Anesthesiologist

1. Minimum of three years anesthesia training

2. Cannot be blinded, but will not contact/communicate with patient after
surgery

2. Appropriate laterality identified

3. Site prepared using aseptic technique

4. Localization of target site beneath fascia iliaca plane using portable
ultrasound

1. Aseptic preparation of probe with sterile sheath

2. 38mm linear probe (BK Medical, USA)

3. 15 MHz frequency

5. Needle: 18g x 10mm echogenic enhanced needle

6. 20G catheter inserted 3 cm beyond needle tip ii. Local anesthetic bolus

1. Ropivacaine 0.5 ml/kg total in divided doses

a. Aspirate every 5 ml

2. Administered via needle iii. Dressing:

1. Liquid adhesive to skin 2. Sorbaview dressing (2x2) applied directly over
catheter on skin 3. Catheter coiled once on top sorbaview and clear plastic
dressing applied over sorbaview 4. 3x3 gauze taped over dressing to cover insertion
site 5. Catheter labeled: "Fascia Iliaca Catheter" b) Control Group i. Fascia
Iliaca Catheter placement

1. Administrator: Regional Anesthesiologist

1. Minimum of three years anesthesia training

2. Cannot be blinded, but will not contact/communicate with patient after surgery
2. Appropriate laterality of surgery identified 3. Site prepared using aseptic
technique 4. Localization of target site beneath fascia iliaca plane using
portable ultrasound

a. Aseptic preparation of probe with sterile sheath b. 38mm linear probe (BK
Medical, USA) c. 15 MHz frequency 5. 20 g catheter tip laid at appropriate
insertion site ii. Dressing:

1. Liquid adhesive to skin 2. Sorbaview dressing (2x2) applied directly over
catheter on skin 3. Catheter coiled once on top sorbaview and clear plastic
dressing applied over sorbaview 4. 3x3 gauze taped over dressing to hide insertion
site 5. Catheter labeled: "Fascia Iliaca Catheter"

3. Infusion

a) Pharmacy to prepare and label all infusion syringes b) Actual content (ropivacaine
0.1%) to be covered but immediately available in case of need to know. Violation of
blinding to be obvious when tubing set removed. A non-blinded member of the study team
will remove the set.

i. Drug Group: Ropivacaine 0.1% ii. Control: Ropivacaine 0.1% to plastic bag c) Device:
bodyguard infusion pump d) Rate: 0.3 ml/kg/hr; max 15 to start within the first hour
after the block is placed.

e) Infusion bag to be changed out as needed by nursing staff per usual routine (depends
on volume of bag, weight of patient)

4. Surgical Procedure

1. Hip arthroscopy performed i. Pre-operative:

1. Patient padded, per usual method

2. Range Of Motion check by Yen and/or surgical staff

3. Patient placed in traction device

4. Xrays taken (AP pelvis, Dunn, frog leg, false profile). Must get view of
lesion.

5. Leg prepped/draped in normal fashion

2. At conclusion of surgical procedure, patients in both groups to receive standard
local anesthetic infiltration i. 20 cc total

1. 10 ml 0.2% ropivacaine intra-articular into hip joint

2. 5 ml 0.2% ropivacaine to each trochlear site (x2) Post-operative Methods

All patients will remain in the hospital for a minimum of 24 hours following surgery per
Dr. Yen's normal hip arthroscopy standard of care. A blinded observer will record pain
scores at 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, and 24 hours postoperatively.
Pain scores will be measures at rest by an 11-point numeric rating scale (NRS) ranging
from 0-10, where 0 is no pain and 10 is worst pain imaginable. All patients should
complete the study and have measurements at each time point. Patient demographics
including age and gender as well as surgical characteristics including length of
surgery, estimated blood loss, and surgery type will be recorded.

Blinded observers will also record the time until patients require additional morphine,
the amount of morphine consumed at each time it was requested, and whether the patient
reported nausea or experienced vomiting within the first 24 hours post-operatively.

5. PACU a) Time 0 = PACU arrival time b) Pain scores: i. Obtained by trained, blinded nurse
observers ii. Recorded per policy with minimum evaluation every 15 minutes iii. Recorded
using 11 point numeric rating scale (NRS) 1. 0 = no pain; 10 = severe pain c) PCA
(patient controlled analgesia) available and initiated upon arrival to PACU i. Opioid:
morphine ii. Bolus dose: 0.025 mg/kg; lockout 10 minutes iii. Hourly limit: 0.15
mg/kg/hr iv. Nurse rescue bolus: 0.05 mg/kg; lockout 60 minutes 1. To be administered
for NRS > 7 v. continuous hourly infusion = 0

6. Inpatient Wards

1. Nurses will evaluate pain per usual practice. Documented minimum every 4 hours. i.
pain scores >7, nurse will administer: nurse rescue bolus via PCA ii. No dermatome
test to prevent the introduction of bias by inadvertently un-blinding subjects.

Pharmacokinetic Methods To determine the pharmacokinetics of ropivicaine during standard
fascia iliaca block [10-13].

1. Following induction of general anesthesia, a large bore IV catheter will be inserted for
the purpose of blood draws (all patients)

2. Blood Sampling (all patients)

1. Volume 2ml

2. Time = zero defined as immediately following bolus of ropivicaine or sham
equivalent

3. First hour: collected at 5, 10, 15, 30, 35, and 60 minutes.

3. Analysis:

1. Internal lab

2. Blood samples will be centrifuged to separate the plasma and stored at -20 degrees
C until assay. Plasma ropivacaine levels analyzed by gas chromatography

Inclusion Criteria:

1. Patient age at surgery is 12-35.

2. Able to provide informed consent and/or assent.

3. Diagnosis is Femoro-acetabular impingement (FAI) and/or labral tear.

4. Surgery will involve and be limited to hip arthroscopy and osteoplasty of the
acetabular rim or femoral head/neck junction.

5. Surgery will be performed by Dr. Yi-Meng Yen.

6. Admission status: 24 hour admission to hospital.

7. No contraindication to study procedures

Exclusion Criteria:

1. Hip revision surgery

2. Underlying neurologic disorder affecting pain perception.

3. Underlying neurocognitive disorder or developmental delay affecting ability to convey
feelings of pain to medical staff.

4. Underlying opioid use or addiction.

5. Significant concomitant hip pathology.

6. Active infection over catheter site.

7. History of chronic pain (not localized to the hip) requiring consistent opioid
consumption for greater than or equal to 6 months within year prior to surgery.

8. Allergy to local anesthetics

9. Allergy to fentanyl

10. Allergy to midazolam

11. Allergy to morphine

12. American Society of Anesthesia class 3 or higher.