Clinical trial NCT03983941
Conditions: Anterior Cruciate Ligament Tear
Sponsor: Sujana Dontukurthy
Start date: 2019-08-30; Completion date: 2019-11-07
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective study comparing femoral nerve block plus sciatic nerve block to femoral nerve block plus infiltration of the posterior knee capsule (IPACK) in patients undergoing arthroscopic anterior cruciate ligament reconstruction. Femoral nerve block via the adductor canal (FNB-AC) with IPACK may provide effective analgesia while avoiding the motor block involved with sciatic nerve block. The lack of motor block is important to facilitate postoperative ambulation and physical therapy.

Detailed description:

Arms: arm 1: Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for sciatic nerve block under ultrasound guidance. arm 2: Patients will receive up to 20 mL of 0.2% ropivacaine for FNB-AC and up to 20 mL of 0.2% ropivacaine for posterior knee capsular infiltration under ultrasound guidance (IPACK)
Interventions: intervention 1: Ropivacaine injection
Intervention descriptions: intervention 1: Total dose not to exceed 3 mg/kg of ropivacaine.

Protocol documents:
Prot_SAP_000.pdf: 
 
Comparison of postoperative analgesic efficacy of adductor canal block with IPACK versus 
adductor canal and popliteal sciatic nerve block in patients undergoing arthroscopic 
anterior cruciate ligament reconstruction 
 
 
NCT03983941 
 
 
 
March 15, 2021 
 
 
 


PROTOCOL TITLE: IPACK versus popliteal sciatic nerve block in ACL reconstruction 
 
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HRP-503  v.12.10.18 
PROTOCOL TITLE: 
Comparison of postoperative analgesic efficacy of adductor canal block with 
IPACK versus adductor canal and popliteal sciatic nerve block in patients 
undergoing arthroscopic anterior cruciate ligament reconstruction. 
PRINCIPAL INVESTIGATOR: 
Name: Sujana Dontukurthy, MD 
Department/Center: Anesthesiology & Pain Medicine 
Telephone Number: 614-722-4200 
Email Address: Sujana.Dontukurthy@nationwidechildrens.org 
VERSION NUMBER/DATE: 
Version 6 / March 15, 2021 
REVISION HISTORY 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
8/13/2019 
Changing block meds to what is currently 
standard of care. 
No 
2 
9/3/2019 
Adding 0.2 mg/ml of dexamethasone to the 
sciatic & IPACK, which was missed in the last 
revision. 
No 
3 
9/17/2019 
Adding epinephrine 1:200,000 to the sciatic & 
IPACK, which was missed in the last revision. 
No 
4 
9/27/2019 
Changing femoral nerve block via the adductor 
canal to just femoral nerve block, removing 
acetaminophen at the end of surgery, and 
removing the motor and sensory evaluations in 
the PACU. 
Yes 
5 
3/15/2021 
Adding information about obtaining signature 
of 2nd parent in section 22.3. 
No 
 
 
 


PROTOCOL TITLE: IPACK versus popliteal sciatic nerve block in ACL reconstruction 
 
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HRP-503  v.12.10.18 
1.0 
Study Summary 
 
Study Title 
Comparison of postoperative analgesic efficacy of femoral 
nerve block with IPACK versus femoral and popliteal sciatic 
nerve block in patients undergoing arthroscopic anterior 
cruciate ligament reconstruction. 
Study Design 
Prospective study 
Primary Objective 
The primary objective of the study is to compare the 
analgesic efficacy of FNB with IPACK versus FNB with 
sciatic nerve block in patients undergoing ACL repair by 
monitoring postoperative pain scores. 
Secondary 
Objective(s) 
The secondary objective is to show a decreased incidence of 
adverse effects including motor blockade with IPACK 
compared to sciatic nerve block and to demonstrate that it is 
technically less challenging by showing a decreased time 
required for performance of the block. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Patients will receive up to 20 mL of 0.5 % ropivacaine  with 
epinephrine 1:200,000 and 0.2 mg/ml of dexamethasone for 
FNB-AC and up to 20 mL of 0.5% ropivacaine with 
epinephrine 1:200,000 and 0.2 mg/ml of dexamethasone for 
sciatic nerve block or posterior knee capsular infiltration. 
IND/IDE #  
N/A 
Study Population 
Patients undergoing elective anterior cruciate ligament 
reconstruction. 
Sample Size 
50 
Study Duration for 
individual 
participants 
Total of 2 weeks. 
Study Specific 
Abbreviations/ 
Definitions  
IPACK – infiltration of the posterior knee capsule 
FNB - Femoral nerve block  
PACU – post-anesthesia care unit 
POD – post-op day 
 
2.0 
Objectives 
2.1 The primary objective of the study is to compare the analgesic efficacy of 
FNB with IPACK versus FNB with sciatic nerve block in patients 
undergoing ACL repair by monitoring postoperative pain scores. 
2.2 The secondary objective is to show a decreased incidence of adverse effects 
including motor blockade with IPACK compared to sciatic nerve block and 
to demonstrate that it is technically less challenging by showing a decreased 
time required for performance of the block. 
2.3 We hypothesize that FNB with IPACK provides the same analgesic efficacy 
as FNB with sciatic block while avoiding the motor blockade associated with 
sciatic nerve block. 
3.0 
Background 


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3.1 Anterior cruciate ligament reconstruction is one of the most common 
orthopedic surgical procedures performed on an outpatient basis.1 
The ability to effectively discharge these patients is primarily 
determined by the efficacy of postoperative pain control.  Regional 
anesthetic techniques are commonly used to provide postoperative 
analgesia as they provider superior analgesia when compared to 
opioids and have also been shown to facilitate same day, outpatient 
discharge home.2  Various regional techniques have been used, 
generally combining blockade of the femoral and sciatic nerve to 
provide analgesia of the knee and surrounding structures.  
Performance of the sciatic nerve block can be technically challenging 
and time consuming. One alternative to sciatic nerve block is 
infiltration of the posterior knee capsule (IPACK) under ultrasound 
guidance.  Results with IPACK in adults for posterior knee joint 
analgesia in patients undergoing total knee arthroplasty have been 
comparable to sciatic nerve block. Furthermore, IPACK is technically 
less challenging as it is only infiltration of the knee capsule below the 
division of the sciatic nerve, without targeting for nerves, and is not 
associated with motor block.3   
3.2 The aim of the current study is to determine if the analgesic efficacy 
of IPACK is similar to sciatic nerve block thereby reducing the side 
effects involved with sciatic nerve block as well as the technical 
challenges of performing the block.  
4.0 
Study Endpoints 
4.1 The time for performance of the block (FNB plus sciatic versus FNB 
plus IPACK). 
4.2 Intraoperative opioid (fentanyl) and inhalational anesthetic agent 
(sevoflurane) requirements. 
4.3 Pain scores and opioid requirements in the PACU. 
4.4 Degree of sensory and motor block in phase I (PACU) and phase 2 
recovery. 
4.5 Post-discharge opioid requirements and pain scores (pain diary). 
4.6 Duration of subjective postoperative sensory and motor blockade. 
5.0 
Study Intervention/Investigational Agent 
5.1 Study subjects will receive up to 20 mL of 0.5% ropivacaine  with 
epinephrine 1:200,000 and 0.2 mg/ml of dexamethasone for FNB and 
up to 20 mL of 0.5% ropivacaine with epinephrine 1:200,000 and 0.2 
mg/ml of dexamethasone for sciatic nerve block under ultrasound 
guidance or posterior knee capsular infiltration under ultrasound 
guidance (IPACK), the total dose not to exceed 3 mg/kg of 
ropivacaine. 


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5.2 Both the FNB and sciatic nerve blocks are considered standard of 
care at NCH.  The IPACK is not currently performed at NCH. 
6.0 
Procedures Involved* 
6.1 Following informed consent, patients will be randomized into one of 
the two groups. Intraoperative anesthetic care will not vary from our 
usual practice. Patients requiring preoperative anxiolysis will receive 
oral midazolam (0.3-0.5 mg/kg, maximum 20 mg) 30 minutes prior 
surgery or intravenous midazolam (0.05 mg/kg, maximum 2 mg) 
prior to transport to the operating room. Standard American Society 
of Anesthesiologists’ monitors will be placed.  Once in the operating 
room, anesthesia will be induced by the intravenous or inhalational 
route as clinically indicated. All subjects will receive propofol (2-3 
mg/kg) and fentanyl (2μg/kg). Following the induction of anesthesia, 
an appropriately sized laryngeal mask airway (LMA) will be placed. 
After the regional anesthesia time out, patients will receive the block 
based on the group assigned from a randomization list created by 
www.sealedenvelope.com.  The time from the initiation of the time-
out for the block until the patient has been returned to the surgical 
position will be noted.  
6.2 The following demographic and surgical parameters will also be 
collected and recorded: patient age, gender, race/ethnicity, height, 
weight, ASA status, primary diagnosis, list of comorbidities, 
procedure date and duration, admission status, intraoperative 
medications and postoperative medications, PACU arrival and 
discharge times, discharge destination, pain scores (including 
recorded time), regional anesthetic time and dose, postoperative 
opioids consumed and time of hospital admission and discharge. 
6.3 Group 1: Patients will receive up to 20 mL of 0.5% ropivacaine with 
epinephrine 1:200,000 and 0.2 mg/ml of dexamethasone for FNB 
and up to 20 mL of 0.5% ropivacaine with epinephrine 1:200,000 
and 0.2 mg/ml of dexamethasone for sciatic nerve block under 
ultrasound guidance, the total dose not to exceed 3 mg/kg of 
ropivacaine (total volume 1.5 mL/kg of 0.2% ropivacaine). For 
patients who weigh less than 30 kg, the volume of the local 
anesthetic will be reduced to keep the total dose at ≤ 3 mg/kg.  
Group 2:  Patients will receive up to 20 mL of 0.5% ropivacaine with 
epinephrine 1:200,000 and 0.2 mg/ml of dexamethasone for FNB 
and up to 20 mL of 0.5% ropivacaine with epinephrine 1:200,000 
and 0.2 mg/ml of dexamethasone for posterior knee capsular 
infiltration under ultrasound guidance (IPACK), the total dose not to 
exceed 3 mg/kg of ropivacaine. For patients who weigh less than 30 
kg, the volume of the local anesthetic will be reduced as needed to 
keep the total dose at ≤ 3 mg/kg. 


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6.4 For intraoperative increases in heart rate or systolic blood pressure ≥ 
20% above the baseline, fentanyl (1 μg/kg) will be administered 
every 5 minutes until the heart rate is below this threshold. 
Prophylaxis for postoperative nausea and vomiting will include 
ondansetron (0.1-0.15, maximum 4 mg). At the conclusion of the 
procedure, all patients will receive ketorolac (0.5 mg/kg, maximum 
30 mg). 
6.5 Patients experiencing severe pain with VAS scores >7 at the surgical 
site will be considered as failed FNB or sciatic nerve block and will 
be withdrawn from the study. In the postoperative care unit, the 
nursing staff will be blinded to which group the patient was assigned 
to, reducing bias.  Fentanyl (1 μg/kg, maximum 50 μg) will be 
administered every 5-10 minutes as needed until the patient’s visual 
analogue score (VAS) score is ≤ 4. VAS will be evaluated every 
hour until discharge.  When the patients are ready for discharge and 
tolerating oral intake, analgesia will be changed to hydrocodone with 
acetaminophen, 1 tablet by mouth if needed, prior to discharge 
home. 
6.6 Patients will be discharged home with postoperative pain medication 
to include hydrocodone with acetaminophen. Parents will be 
instructed to administer one tablet every 4 hours as needed when the 
VAS score is greater than 4.  If the patient does not tolerate 
hydrocodone, the patient will be given the option for ibuprofen 10 
mg/kg every 6 hours.  Caregivers will be given a diary to record the 
amount of pain medication consumed, pain scores (every 4-6 hours), 
and the duration of motor block as reported by the patient. On 
postoperative day 1(or 2 for a later discharge), a member of the study 
team will call to collect the information for a total of 24 hours 
following hospital discharge. The study investigator will also contact 
the patients 2 weeks after the procedure to assess for any adverse 
events not detected during the initial data collection. 
7.0 
Data and Specimen Banking* 
N/A 
 
8.0 
Sharing of Results with Subjects* 
8.1 Results will not be shared. 
9.0 
Study Timelines* 
• 
An individual study subject’s participation in the study should last 
approximately 2 weeks total.  
• 
All study subjects should be enrolled within 2 years of study start. 
• 
The study should be completed within 3 years of study start.  
10.0 Inclusion and Exclusion Criteria* 


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10.1 Potential subjects will be identified by reviewing the surgery 
schedule in Epic and will be recruited from the Surgery Unit pre-op 
area prior to their surgery. 
10.2 Inclusion criteria:  Patients 10 - 21 years of age, with American 
Society of Anesthesiologists physical status I and II, undergoing 
elective anterior cruciate ligament reconstruction.  
10.3 Exclusion criteria:  Patients will not participate in the study if any of 
the following apply to them: 
• 
They are unable or unwilling to take part in the study  
• 
History of allergy to any of the medications administered for 
the nerve block 
• 
Contraindication to peripheral nerve block 
• 
Patients who are unable to understand instructions or questions 
related to the study or the families required language 
interpretation.  
• 
Patients who consume opioid medications for more than three 
days per week for more than a month prior to surgery.  
10.4 We are including children, and will not include: 
• 
Adults unable to consent 
• 
Pregnant women 
• 
Prisoners 
11.0 Vulnerable Populations* 
11.1 This study presents no more than minimal risk as it involves regional 
nerve blocks which are used routinely as standard of care by the 
anesthesiologists at this institution.  
12.0 Local Number of Subjects 
12.1 50 
12.2 Sample size will be determined according to previous studies in 
adults. Abdallah et al. described the non-inferiority of the IPACK 
block over 24 hours postoperatively, while Kim et al. described 
superiority of IPACK with respect to pain scores at rest and 
ambulation, as well as opioid consumption, over postoperative days 
0-1. With the greatest pain observed on POD0, our study will be 
powered for comparing the maximal pain score on POD0 between 
the 2 groups. Based on the data presented by Abdallah et al., we 
anticipate that pain scores over POD0 would differ by no more than 
1 point between the groups, on a 0-10 scale. Based on the data 
presented by Kim et al., we hypothesize a standard deviation of pain 
scores of 1.1. Following Abdallah et al, our study will be powered 
for a test of IPACK non-inferiority, such that the null hypothesis will 


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HRP-503  v.12.10.18 
be rejected if pain scores in the IPACK group are >1 point greater 
than in the control group. Under these assumptions, an unpaired one-
tailed t-test would attain 90% power for rejecting the null hypothesis 
at a 95% confidence level when at least 22 patients are enrolled in 
each group. We propose enrolling a total of 50 patients to account 
for non-normal distribution of the primary outcome; protocol 
violations resulting in subject exclusion; and missing data.   
13.0 Recruitment Methods 
13.1 Subjects will be recruited from the surgery unit pre-op area.  They 
will be identified by reviewing OR schedules in Epic. 
14.0 Withdrawal of Subjects* 
14.1  Patients experiencing severe pain with VAS scores >7 at the surgical site 
will be considered as failed FNB or sciatic nerve block and will be 
withdrawn from the study. 
 
15.0 Risks to Subjects* 
15.1 The common side effects of ropivacaine (the numbing medication 
used in the nerve blocks) are injection site burning or pain and 
prickly feeling as the block wears off.  Occasional side effects of 
ropivacaine are ear ringing, metallic taste, and drowsiness. Rare side 
effects of ropivacaine are seizures, unconsciousness, respiratory 
arrest, low blood pressure, irregular heartbeat, cardiac arrest, and 
allergic reactions including anaphylaxis. There is also potential risk 
for loss of confidentiality. 
15.2 Subjects and their families will be approached about the study and 
consented in a private room in the pre-op area by a member of the 
research team.  The information collected will be limited to that 
which is required to achieve the objectives of the study and will not 
be shared with anyone not directly involved in the study.  Subjects 
will be informed of their right to refuse to participate. Subject PHI 
will be stored in a locked cabinet, and will be stored and maintained 
in password protected computer files. 
16.0 Potential Benefits to Subjects* 
16.1 No direct benefit to the subject. 
17.0 Data Management* and Confidentiality 
17.1 Continuous outcomes will be compared between groups using 2-
sample t-test or rank-sum tests according to the normality of the 
distribution (checked by the Shapiro-Wilk test). Categorical 
outcomes will be compared between groups using Chi-square or 
Fisher’s exact tests, according to cell size.  


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17.2 Research records will be stored in a locked cabinet and password 
protected computer.  Only certified research personnel will be given 
access to identifiable subject information 
17.3 Following publication of study results, research records will be 
stored for a period of 3-5 years and then will be destroyed by placing 
in a secure shredding bin.  
18.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
18.1 The study will only be monitored by the study investigators. 
19.0 Provisions to Protect the Privacy Interests of Subjects 
19.1 Subjects and their families will be approached about the study and 
consented in a private room in the pre-op area by a member of the 
research team.  The information collected will be limited to that 
which is required to achieve the objectives of the study and will not 
be shared with anyone not directly involved in the study.  Subjects 
will be informed of their right to refuse to participate. 
20.0 Compensation for Research-Related Injury 
20.1 None 
21.0 Economic Burden to Subjects 
21.1 None 
22.0 Consent Process 
22.1 The consent process will begin in the preoperative surgery unit on 
the day of surgery, by PI, Sub­Investigators, Study Coordinators, 
and/or trained research staff. 
22.2 The study will be thoroughly explained to the patient and their 
family. There will be ample time allotted for questions and answers. 
An explanation of voluntary participation will take place, and the 
family will be asked if they are interested in participating in the 
study. If the patient and their parent(s), or legal guardian agrees to 
participate they will be asked to sign consent and assent forms. The 
patient will then be enrolled in the study with the understanding that 
they can elect to stop the study and be withdrawn from the study at 
any time.  
22.3 If the second parent is not with the patient, since this study requires 2 
parent signatures, the second parent will be contacted by phone, the 
study will be explained to him/her, and we will either obtain verbal 
consent or the document will be scanned, emailed, signed, and 
emailed back. 
23.0 Process to Document Consent in Writing 


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23.1 We will be following SOP: Written Documentation of Consent 
(HRP-091).  
24.0 Setting 
24.1 Subjects will be recruited from Surgery Unit and all study 
procedures will take place in the OR after the subject has been 
anesthetized.  
25.0 Resources Available 
25.1 The department of Anesthesiology and Pain Medicine has 2 research 
coordinators and 2 research associates that will be enrolling subjects 
for this study.  All study staff will be trained on the study 
procedures. 
26.0 Multi-Site Research* 
N/A 
 
27.0  Protected Health Information Recording 
 
1.0 
Indicate which subject identifiers will be recorded for this research. 
☒  Name 
☐  Complete Address 
☐  Telephone or Fax Number 
☐  Social Security Number (do not check if only used for ClinCard) 
☒  Dates (treatment dates, birth date, date of death) 
☐  Email address , IP address or url 
☒  Medical Record Number or other account number 
☐  Health Plan Beneficiary Identification Number 
☐  Full face photographic images and/or any comparable images (x-rays) 
☐  Account Numbers 
☐  Certificate/License Numbers 
☐  Vehicle Identifiers and Serial Numbers (e.g. VINs, License Plate Numbers) 
☐  Device Identifiers and Serial Numbers 
☐  Biometric identifiers, including finger and voice prints 
☐  Other number, characteristic or code that could be used to identify an 
individual 
☐  None (Complete De-identification Certification Form) 
 
2.0   
Check the appropriate category and attach the required form* on the Local 
Site Documents, #3. Other Documents, page of the application.  (Choose one.) 
☒  Patient Authorization will be obtained. (Include the appropriate HIPAA 
language (see Section 14 of consent template) in the consent form OR attach 
the HRP-900, HIPAA AUTHORIZATION form.) 


PROTOCOL TITLE: IPACK versus popliteal sciatic nerve block in ACL reconstruction 
 
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HRP-503  v.12.10.18 
☐  Protocol meets the criteria for waiver of authorization. (Attach the HRP-901, 
WAIVER OF HIPAA AUTHORIZATION REQUEST form.) 
☐  Protocol is using de-identified information. (Attach the HRP-902, DE-
IDENTIFICATION CERTIFICATION form.) (Checked "None" in 1.0 above) 
☐  Protocol involves research on decedents. (Attach the HRP-903, RESEARCH 
ON DECEDENTS REQUEST form.) 
☐  Protocol is using a limited data set and data use agreement. (Contact the 
Office of Technology Commercialization to initiate a Limited Data Use 
Agreement. 
 
*Find the HIPAA forms in the IRB Website Library, Templates. 
 
Attach the appropriate HIPAA form on the “Local Site Documents, #3. 
Other Documents”, page of the application. 
 
3.0    How long will identifying information on each participant be maintained? 
Following publication of study results, research records will be stored for a period 
of 3-5 years and then will be destroyed by placing in a secure shredding bin. 
 
4.0 
Describe any plans to code identifiable information collected about each 
participant. Subject ID numbers will be used on research related documents such 
as the subject journals. 
 
5.0 
Check each box that describes steps that will be taken to safeguard the 
confidentiality of information collected for this research: 
☒ Research records will be stored in a locked cabinet in a secure location 
☒ Research records will be stored in a password-protected computer file 
☐ The list linking the assigned code number to the individual subject will be 
maintained separately from the other research data 
☒ Only certified research personnel will be given access to identifiable 
subject information 
 
6.0 
Describe the provisions included in the protocol to protect the privacy 
interests of subjects, where "privacy interests" refer to the interest of 
individuals in being left alone, limiting access to them, and limiting access to 
their information. (This is not the same provision to maintain the 
confidentiality of data.) 
 
Subjects and their families will be approached about the study and consented in a 
private room in the pre-op area by a member of the research team.  The 
information collected will be limited to that which is required to achieve the 
objectives of the study and will not be shared with anyone not directly involved in 
the study.  Subjects will be informed of their right to refuse to participate. 
 
Confidential Health Information 
 


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1.0 
Please mark all categories that reflect the nature of health information to be 
accessed and used as part of this research. 
 
☒  Demographics (age, gender, educational level) 
☒  Diagnosis 
☐  Laboratory reports 
☐  Radiology reports 
☐  Discharge summaries 
☒  Procedures/Treatments received 
☒  Dates related to course of treatment (admission, surgery, discharge) 
☐  Billing information 
☒  Names of drugs and/or devices used as part of treatment 
☐  Location of treatment 
☐  Name of treatment provider 
☐  Surgical reports 
☒  Other information related to course of treatment 
☐  None 
 
2.0 
Please discuss why it is necessary to access and review the health information 
noted in your response above. 
It is necessary to meet the objectives of the study and to analyze the data. 
 
3.0 
Is the health information to be accessed and reviewed the minimal necessary to 
achieve the goals of this research?  ☒ Yes    ☐ No 
 
4.0 
Will it be necessary to record information of a sensitive nature?  ☐ Yes   ☒ No 
 
5.0 
Do you plan to obtain a federally-issued Certificate of Confidentiality as a means 
of protecting the confidentiality of the information collected?  ☐ Yes   ☒ No 
 
References:  
1. Abdallah FW, Whelan DB, Chan VW, Prasad GA, Edersby RY et, al. Adductor 
canal block provides noninferior analgesia and superior quadriceps strength 
compared with femoral nerve block in anterior cruciate ligament reconstruction. 
Anesthesiology 2016;123:1053-1064. 
2. Schloss B, Bhalla T, Klingele K, Phillips D, Prestwich B, Tobias JD. 
A retrospective review of femoral nerve block for postoperative analgesia after 
knee surgery in the pediatric population. J Pediatr Orthop 2014;34:459-61. 
3. Kim DH, Beathe JC, Lin Y, et al. Addition of infiltration between the popliteal 
artery and the capsule of the posterior knee and adductor canal block to 
periarticular injection enhances postoperative pain control in total knee 
arthroplasty: a randomized controlled trial. Anesth Analg 2018 (in press). 


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4. Amir N. Combined adductor canal and i-PAK blocks is better than combined 
adductor canal and periarticular injection blocks for painless ACL reconstruction 
surgery. J Anes Crit Care 2018;10:154-157.  
5. Korula S, George GM, Ipe S, Abraham SP.  Epidural anesthesia and post-
operative analgesia for bilateral inguinal mesh hernioplasty: Comparison of 
equipotent doses of ropivacaine and bupivacaine. Saudi J Anaesth 2011;5:277-
281.