Clinical trial NCT02365961
Conditions: Hip Dysplasia Femoroacetabular Impingement Acetabular Labrum Tear
Keywords: Hip Arthroscopy
Sponsor: The Hawkins Foundation
Start date: 2015-04-01; Completion date: 2017-06-01
Enrollment: 84 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Detailed description:

Arms: arm 1: 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) arm 2: Local anesthetic in the hip joint consisting of 30cc of 0.5% Noropin
Interventions: intervention 1: ropivicaine intervention 2: clonidine intervention 3: Epinephrine intervention 4: Noropin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Prot_SAP_000.pdf: 
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1 
 Reduction of Hip Arthroscopy Post-operative Pain Using Ultrasound-guided Fascia-iliaca 
Block  
 
Investigators & personnel  
• 
Principle Investigator: 1Eugene Kim, MD 
• 
Co-Investigators: 2Jason Folk, MD; 2John M. Tokish, MD; 1Suzanne Renfro, MD; Steve Lysak, MD; 
Kimberly Balogh, MD; Jarod Motley, MD; Steven Samoya, MD; Randall Wilhoit, MD; Mark 
Mathis, MD  
 
1Greenville Anesthesiology, PA 
2Steadman Hawkins Clinic of the Carolinas, Greenville Health System 
 
 
 


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Protocol Summary 
Title of Study: 
Reduction of Hip Arthroscopy Post-operative Pain Using 
Ultrasound-guided Fascia-iliaca Block  
Study Type: 
Postmarket 
Primary Investigator: 
Eugene Kim, MD 
Primary Endpoint: 
Quantify the difference in pain in patients who have received a 
pre-operative FI block versus those receiving no block 
Secondary & Tertiary 
Endpoints: 
• 
Secondary 
endpoint: 
Quantify 
the 
difference 
in 
opioid 
consumption in patients who have received a pre-operative FI 
block versus those receiving no block (local anesthetic/Noropin 
(30cc of 0.5%) joint injection only). 
• 
Tertiary endpoints: Assess differences in episodes of PONV, time in 
PACU, and proportion of unplanned admissions 
 
Design: 
Prospective, randomized, two-arm, single-blind study 
Length of Study: 
3M follow-up 
Sample Size: 
95 subjects 
 
 
Schedule of Events 
 
BL 
Proc 
2W 
6W 
3M 
Informed Consent 
√ 
- 
- 
- 
- 
Inclusion/Exclusion  
√ 
- 
- 
- 
- 
Surgical Details 
- 
√ 
- 
- 
- 
Physical Exam-ROM 
√ 
- 
√ 
√ 
√ 
Visual Analogue Scale (VAS) 
√ 
- 
√ 
√ 
√ 
Adverse Event Assessment 
- 
√ 
√ 
√ 
√ 
 
 
 


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3 
 
Abbreviations and Acronyms 
FI = fascia iliaca 
US = ultrasound 
PONV = post-operative nausea and vomiting 
PDNV = post-discharge nausea and vomiting 
PACU = post-anesthesia care unit 
 
Introduction / Background  
Hip arthroscopy can be a very painful procedure causing patients distress in the immediate 
post-operative period and beyond. As more and more procedures are planned on an outpatient basis, 
the pain associated with hip arthroscopy can result in unplanned admission of a patient who expected 
to be discharged home after their procedure. Currently, opioids are the mainstay of treatment for pain 
control after hip arthroscopy. Various adjuncts have been tried in the past including multimodal 
analgesia, hip joint injections, and peripheral nerve blocks typically involving the lumbar plexus and the 
femoral nerve. Studies of blocks of the lumbar plexus using the posterior approach have shown good 
results with reduction in patients’ pain scores and opioid consumption. However, because of the 
invasiveness and possible complications of the posterior approach to the lumbar plexus, the anterior 
approach called the fascia iliaca (FI) block is an attractive alternative. Furthermore, earlier studies of the 
FI block were performed without benefit of visual guidance for needle insertion.  With the advent of 
ultrasound guidance, the FI block may be placed with a greater degree of success than in previous years 
when ultrasound guidance was not utilized during the placement of FI block. The aim of the present 
study is to determine if ultrasound guided FI blocks can reduce the pain scores and opioid consumption 
of hip arthroscopy compared to an opioid-only regimen using a randomized controlled trial comparing 
these outcomes in patients getting preoperatively placed FI blocks versus patients not receiving a block. 
A significant improvement in pain control and opioid consumption in FI patients compared to controls 
could provide a basis for increased utilization of FI blocks for this procedure with the attendant benefits. 
Other outcomes assessed include unplanned admission, PONV and PDNV from decreased narcotic 
usage, and decreased time in the PACU. 
 
• 
Primary objectives: Quantify the difference in pain score and opioid consumption in patients 
who have received a pre-operative FI block versus those receiving no block (local anesthetic 
joint injection only). 
• 
Secondary objectives: Assess differences in episodes of PONV, time in PACU, and proportion 
of unplanned admissions compared to patients with joint injection only 
• 
Hypothesis: Pre-operative placement of an ultrasound-guided fascia iliaca block in patients 
undergoing hip arthroscopy will result in reduced pain scores and opioid consumption compared 
to patients receiving an opioid-only regimen. 
• 
Secondary hypothesis: Pre-operative placement of an ultrasound-guided fascia iliaca block 
in patients undergoing hip arthroscopy will result in fewer episodes of PONV, reduced time 
in PACU, and lower rates of unplanned admissions compared to patients receiving an 
opioid-only regimen. 
Study Methodology  
• 
Study Description 


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• 
Design:  Randomized controlled trial 
• 
Blinding:  
• 
 
Blinded: Data analyst 
• 
 
Unblinded: patient, surgeon and anesthesiologist 
• 
Location: Greenville Health System (Patewood Outpatient Hospital and Hillcrest 
Memorial Hospital) 
• 
Sample size:  Sample size estimates are based on the assumptions of a large clinical 
effect size (>.40) seen at 5 follow up points for the primary outcome measure of pain. 
Using a fixed effects, special, main and interactions, analysis of variance testing (ANOVA) 
with a power of 0.80 and an alpha of 0.05, we estimate the need for 86 subjects to 
achieve statistical significance. To account for loss of follow up, we will target 10% more 
subjects, thus 95 total participants.    
• 
Study population 
• 
Subjects   
• 
Recruitment: Consecutive patients undergoing hip arthroscopy will be enrolled in the 
study  
• 
Inclusion criteria: 
• 
Scheduled for outpatient hip arthroscopy by Dr. Folk  
• 
ASA 1-3 
• 
Ages 18-65 
• 
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 


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• 
Study procedure  
At the pre-operative clinic appointment, patients will be recruited into the study.  Informed consent 
will be obtained from the patient by the study doctor.  The nature of the experiment will be explained, 
specifically that the patient agrees to be randomized to receive a block prior to the operation or to 
receive the joint injection at the conclusion of the surgery as an adjunct to general anesthesia.  If the 
patient agrees to enter into the study, the patient will be randomized by use of a computer generated 
randomization program at the time of enrollment in the clinic.  Currently, the standard of care at the 
Steadman Hawkins Clinic of the Carolinas is to offer surgical patients a block as an analgesic option.  FI 
blocks are not ordered by the doctor without a request by the patient.  If patients do not receive a FI 
block, they will receive a local anesthetic intraoperatively by the surgeon at the close of the procedure, 
which is also currently the standard of care for hip surgery. 
 
 
On the day of surgery, all patients will receive multimodal analgesia with an oral preoperative cocktail 
consisting of acetaminophen 15mg/kg up to a maximum of 1000mg, celebrex 400mg, lyrica 75mg, and 
oxycontin 10mg unless they are allergic to any of the components. Both block (B) and non-block (NB) 
patients will receive pre-operative midazolam 1-5 mg as needed for procedural sedation (B) or 
pre-operative anxiety (NB) respectively. 
 
Patients to be blocked will receive not less than 50 ml and 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) placed using a 17 
gauge 3.2” B-Braun Tuohy needle under ultrasound guidance using a SonoSite S-Nerve machine with a 
15-10 MHz 38 mm probe using a caudad to cephalad in-plane approach. (A 70kg patient would receive 
all 60 mL of the block solution and 210mg of ropivicaine total).  The blocks will be placed exclusively by 
a selected group of anesthesiologists, who have been trained in the technique. 
 
Patients who are randomized to no-block will receive a single injection of Noropin in the joint space. 
 
General anesthesia will be conducted in a standard fashion for all patients. General anesthesia with an 
endotracheal tube will be induced with IV fentanyl 2 mcg/kg, lidocaine 50mg, propofol 2 mg/kg, and 
rocuronium 0.6 mg/kg unless another plan is chosen at the discretion of the attending anesthesiologist. 
Maintenance of anesthesia will be done with O2:air FIO2 50%, isoflurane end-tidal concentration of 
0.7-1.4%, and tidal volumes of 7-10 mL/kg with a respiratory rate to maintain an end-tidal carbon 
dioxide concentration of 30-40 mmHg. Fentanyl will be given in 25-50 mcg increments for HR or BP 
greater than 20% over baseline. No long acting intra-operative opioids will be administered and only 
fentanyl will be used. Ephedrine in 5-10 mg increments or neosynephrine in 80-160 mcg increments will 
be used to treat hypotension at the anesthesiologist's discretion. A minimum of 20mL/kg of IV 
crystalloid will be administered during the surgery. Ondansetron 4 mg IV will be administered to all 
patients approximately 30 minutes prior to emergence for PONV prophylaxis. 
 
Post-operatively in the recovery room, hydromorphone will be used as a first line opioid for pain given in 
0.2-0.5 mg increments to an initial maximum of 4 mg. Nausea will be treated in a stepwise fashion with 
promethazine 6.25 mg IV as a first line agent. Second line will be a repeat dose of promethazine 15 
minutes after the first dose, followed by diphenhydramine 6.25 mg IV 15 minutes later PRN. Pain scores 
will be recorded initially upon arrival to the PACU and thereafter until the patient is discharged from the 
PACU. All episodes of nausea and vomiting will be tallied. Total recovery time in the PACU will be 
recorded. If a patient is otherwise ready for discharge but remains in the PACU due to a non-medical 
issue (i.e. bed hold), the time at which the patient could have otherwise been discharged will be 


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recorded as the PACU end time for the purposes of the study. Any unplanned admissions will be noted. 
All opioids administered intraoperatively and in the PACU will be recorded and converted to morphine 
equivalents.  
Patients will be followed in the study surgeon’s clinic office per his standard protocol at 2 weeks, 6 
weeks, and 3 months post-operatively.  Pain scores will be evaluated at this time.  Clinical outcome 
measures and range of motion of the patients’ hips will be collected at this time as well.  Any adverse 
reaction from the block will be noted and recorded at all times from the administration of the block and 
at each clinic follow up.  Any signs or symptoms of numbness in the distribution of the fascia iliaca 
block will be noted.   
 
• 
Primary endpoint: Quantify the difference in pain in patients who have received a pre-operative FI 
block versus those receiving no block. 
• 
Secondary endpoint: Quantify the difference in opioid consumption in patients who have 
received a pre-operative FI block versus those receiving no block. 
• 
Tertiary endpoints: Assess differences in episodes of PONV, time in PACU, and proportion of 
unplanned admissions 
  
• 
Risks / benefit 
• 
Risks associated with FI blocks are the following: 
Overall the procedure has a very low risk profile. The location of the injection means the risk of 
intravascular injection, local anaesthetic toxicity, and mechanical nerve damage is extremely 
low. 
Good aseptic technique will minimize the risk of infection. The injection of a large volume of 
local anaesthetic ensures good spread and reduces the risk of failure. The risk of local 
anaesthetic toxicity is highest within the first 15 minutes after injection, which makes close 
monitoring mandatory. 
 
• 
The potential benefit is improvement in pain control and opioid consumption in FI patients.  
The knowledge gained from this study will also be used in future patients with this condition. 


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• 
Statistical Analysis  
The study incorporates four dedicated follow up points beyond baseline: a) perioperative (1 to 5 days), 
b) 2 weeks, c) 6 weeks, and d) 3 months. The primary outcome measure (pain) will be analyzed using a 
fixed effects, special, main and interactions, analysis of variance testing (ANOVA). Opioid consumption 
will be analyzed using a Pearson chi square or parametric equivalent (depending on final coding). 
Tertiary end points will be captured using an ANOVA for continuous measures (once tests of normality 
are completed), or Kruskal Wallis, whereas re-admission rates will be analyzed using a Pearson 
Chi-square. A p value of 0.05 will be considered statistically significant for all findings. Intention to treat 
and last value carried forward will be integrated for all analyses.    
 
 
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