Hernia, InguinalPhase 4NCT02110745
The Effect of Induction Technique on Postoperative Pain and Agitation
A Phase 4 study testing Sevofluorane and Propofol in people with Hernia, Inguinal and Cryptorchidism, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study was to determine (a) whether patients anesthetized with intravenous propofol have less pain compared with sevofluorane for paediatric inguinal hernia and undescended testis operations and (b) whether intravenous propofol anesthesia has better quality of recovery compared with sevofluorane… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Hernia, Inguinal, Cryptorchidism
- What is being tested?
- Sevofluorane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2014to Nov 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- American Society of Anesthesiologists I-II
- 2-12 years old patients
- Patients for elective inguinal hernia and undescended testis operations.
Who cannot join
- Children with developmental problems
- Cerebral palsy
- Down syndrome
- Inborn errors of metabolism
- A history of epileptic fits
- Body weight less than 10 kg or greater than 30 kg (children below age of 6 years with body weight more than 30 kg are definitely obese with a risk of airway obstruction along with the abnormal volume of distribution of drugs if given according to their actual body weight)
- Patients with known allergy to any of the medications used
- Procedures lasted less than 30 min or longer than 2 h.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mustafa Kemal University Medicine Faculty Anesthesiology Department
Hatay, 31000
About this study
Official title: THE EFFECT OF DIFFERENT INDUCTION TECHNIQUES ON POSTOPERATIVE PAIN AND AGITATION IN CHILDREN
The objective of this study was to determine (a) whether patients anesthetized with intravenous propofol have less pain compared with sevofluorane for paediatric inguinal hernia and undescended testis operations and (b) whether intravenous propofol anesthesia has better quality of recovery compared with sevofluorane anesthesia in the immediate postoperative period after paediatric inguinal hernia and undescended testis operations.
Read the detailed description
DIFFERENT INDUCTION TECHNIQUES ON AGITATION AND POSTOPERATIVE PAIN IN CHILDREN AFTER INGUINAL HERNIA AND CRYPTORCHIDISM Inguinal hernia and cryptorchidism are probably the most common operations in the paediatric age group. Inguinal hernia is the most common indication for surgery in the paediatric age group and the incidence of inguinal hernia in those younger than 18 years old varies from 0.8 to 4.4% (1). Cryptorchidism is the most common genital anomaly in boys and incidence is 3.5% of all full- term infants (2).
Advances in surgical techniques and anesthesia management most of the children can be discharged on the day after these kind of operations (3). Most studies of analgesia in pediatric day case surgery have focused on the postoperative pain risk at night, because it becomes the great problem for the parent. Because half of children experience clinically significant pain after discharge according to pain studies done for children (4).
Volatile anesthetics can activate peripheral neurons that play important role on pain perception in postoperative period (3). Zhang et al reported that volatile anesthetics have been demonstrated to have hyperalgesic effects (5). In addition the other studies reported that volatile anesthetic induced pain enhancement was mediated by modulation of central adrenergic and cholinergic transmission (6)(7). Also modulation of 5-Hidroxytriptamine3 receptor-mediated currents by volatile anesthetics may also play a role in their pronociceptin effect (8)(9).
The recovery profile studies comparing IV propofol anesthesia with inhaled anesthetics have shown a better postoperative analgesia with propofol (10)(11). A recent study Tan et al shown that the patients anesthetized with intravenous propofol anesthesia for surgery had less pain than patients anesthetized with sevofluorane (12). A different study by Cheng et al investigating the postoperative analgesic effects of nicotine nasal spray coincidentally found that patients anesthetized with propofol had less postoperative pain than patients anesthetized with isofluorane over the postoperative 24 hours (13).
Animal studies suggested that propofol suppressed nociceptive behavior. Propofol known to have nociceptive effects by activating transient receptor potential ion channel (14)(15) has been demonstrated to have analgesic and antihyperalgesic properties at sedative doses in a human pain model (16) In normal rat model, propofol has direct actions on the dorsal horn neurons of the spinal cord, which played an important role in the processing of sensory information (17) In a rat formalin model, propofol produced antinociceptive effect in a dose-dependent manner (18). Moreover, subhypnotic doses of propofol has been demonstrated to delay and weaken remifentanil induced post-infusion hyperalgesia in human (19).
The objective of this study was to determine (a) whether patients anesthetized with intravenous propofol have less pain compared with sevofluorane for paediatric inguinal hernia and undescended testis operations and (b) whether intravenous propofol anesthesia has better quality of recovery compared with sevofluorane anesthesia in the immediate postoperative period after paediatric inguinal hernia and undescended testis operations.
MATERIAL METHODS After obtaining institutional ethics committee approval and written informed consent, 100 American Society of Anaesthesiologists I-II children, aged between 2 and 12 years undergoing elective surgery for inguinal hernia repair and undescended testis were enrolled in the study. The study used a double-blind methodology with random allocation to the two groups by a computer-generated list.
All patients' parents will be instructed on the use of the Wong-Baker Faces Pain scales for pain assessment before the induction of anesthesia. Both of the hands will be applied Eutectic Mixture of Local Anesthetics Cream (Lidocaine Hydrochloric acid, prilocaine, Astra Zeneca, Istanbul, Turkey) 60 minutes before the operations by the nurse. All the children were premedicated with midazolam hydrochloride 0.6 mg/kg orally; maximum 30 min prior to the surgery and we made sure that the drug was given under the tongue to avoid first liver passage. Patients will be monitored in the operating room. Heart rate (HR) mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) were recorded. Patients will be randomized into 2 groups using a computer-generated random number table: the first group will be inducted with iv propofol (Group P) and after sevofluorane inhalation will continue, the second group (Group S) will be inducted and continued with sevofluorane. Anesthesia was maintained with sevofluorane titrated to a value of 40 bispectrial index.
I.Grup 1: Sevofluorane 8% mask induction and continue with 2% sevofluorane I.Grup 2: Propofol 2.5mg/kg in induction and continue with 2% sevofluorane Fluid therapy was standardized during and after surgery. During surgery, children received lactated Ringer's solution 6 ml/ kg/ h whereas 5% dextrose with electrolytes was given at a rate of 4 ml/ kg/ h in the postoperative period. Induction of anesthesia is performed using oxygen (FiO2 0.33), nitrous oxide (FiO2 0.66), and sevofluorane (increasing concentrations up to 8%) administered by mask. After sevofluorane induction intravenous cannula will be inserted. The other group propofol 2.5mg/kg in induction and continue with 2% sevoflorane. After 0.5 mg/kg rocuronium and 1 mcg/kg fentanyl will be applied before intubation. 5 minutes after induction heart rate, tension arterial, saturation will be recorded. Both of the groups will be maintained with 2% sevofluorane and 40% nitrous oxide. All the operations will be done with the same technique by the same surgeon. After spontaneous breathing , the reverse will be applied as 0.03 mg/kg neostigmine ve 0.01 mg/kg atropine intravenous. After reversal of airway reflexes, the patients will be extubated. After extubation the patients will be in postanesthesia recovery room. Operation time, anesthesia time will be recorded. First eye opening, first verbal command follow, staying time in PACU, first analgesic time, ambulation time, first oral intake time, extermination time will be recorded according to the anesthesia completion time. Completion of the surgery, 20 mg/kg rectal paracetamol will be applied as suppository form. However If VAS≥3 then 20 mg/kg paracetamol will be applied in intravenous form. Heart rate, tension arterial, saturation, respiratory rate, agitation scale, Wong-Baker Faces Pain rating scale for pain will be assessed and recorded. If agitation score≥4 then 1mcg/kg fentanyl will be applied intravenously. Wong-Baker Faces Pain rating scale will be taught to all parents and how to sign according to shapes of the faces of all children (No pain-smiling face to most pain-crying face). Transition from PACU to surgical ward was considered safe when patient had achieved a Modified Aldrete Score 9 for at least 10 min, and SpO2 95% with oxygen 2 l/min or 92% without oxygen, signified recovery of physical, mental, and physiological function to near preanesthetic levels. Furthermore, 10-point analogue scales were used to measure parents' satisfaction with their child's overall anaesthetic and surgical care and satisfaction with their participation in decisionmaking (0 . not at all satisfied, 10 . extremely satisfied). All adverse events (bronchospasm, laryngospasm, desaturation, hypotension, bleeding, reoperation) will be recorded for postoperative 0h(PACU), 10 min, 20 min, 30 min, 40 min, 50 min, 1h, 2h, 4h, 6h, 12h, 24h.
- Conditions
- Hernia, Inguinal, Cryptorchidism
- Being tested
- Sevofluorane, Propofol
- Medical subject headings
- Hernia, Inguinal, Cryptorchidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluoraneDrug
Also called Sevorane
Comparison of different induction drugs and techniques
PropofolDrug
Also called pofol
Comparison of different induction drugs and techniques
| Study group | Role | What they receive |
|---|---|---|
| Sevofluorane | Experimental | Sevofluorane 8% in induction Receives: Drug: Sevofluorane |
| Propofol | Experimental | Propofol 2.5 mg/kg intravenous in induction Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Measured: Postoperative 24 hours
Secondary outcomes (1)
Postoperative agitation
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Koyuncu, Mustafa Kemal University
- Investigators
- Selim Turhanoglu, Prof, Principal investigator, Mustafa Kemal University medicine faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110745
- Sponsor's protocol ID
- 267
- Status last verified
- Mar 2015
- First submitted
- 26 Mar 2014
- Last updated
- 13 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tan T, Bhinder R, Carey M, Briggs L. Day-surgery patients anesthetized with propofol have less postoperative pain than those anesthetized with sevoflurane. Anesth Analg. 2010 Jul;111(1):83-5. doi: 10.1213/ANE.0b013e3181c0ee9e. Epub 2009 Nov 12.
PubMed 19910624Li M, Mei W, Wang P, Yu Y, Qian W, Zhang ZG, Tian YK. Propofol reduces early post-operative pain after gynecological laparoscopy. Acta Anaesthesiol Scand. 2012 Mar;56(3):368-75. doi: 10.1111/j.1399-6576.2011.02603.x. Epub 2011 Dec 23.
PubMed 22192060
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF DIFFERENT INDUCTION TECHNIQUES ON POSTOPERATIVE PAIN AND AGITATION IN CHILDREN
- ClinicalTrials.gov ID
- NCT02110745
- Acronym / sponsor ID
- 267
- Conditions
- Hernia, Inguinal, Cryptorchidism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study was to determine (a) whether patients anesthetized with intravenous propofol have less pain compared with sevofluorane for paediatric inguinal hernia and undescended testis operations and (b) whether intravenous propofol anesthesia has better quality of recovery compared with sevofluorane anesthesia in the immediate postoperative period after paediatric inguinal hernia and undescended testis operations.
Detailed description
DIFFERENT INDUCTION TECHNIQUES ON AGITATION AND POSTOPERATIVE PAIN IN CHILDREN AFTER INGUINAL HERNIA AND CRYPTORCHIDISM Inguinal hernia and cryptorchidism are probably the most common operations in the paediatric age group. Inguinal hernia is the most common indication for surgery in the paediatric age group and the incidence of inguinal hernia in those younger than 18 years old varies from 0.8 to 4.4% (1). Cryptorchidism is the most common genital anomaly in boys and incidence is 3.5% of all full- term infants (2).
Advances in surgical techniques and anesthesia management most of the children can be discharged on the day after these kind of operations (3). Most studies of analgesia in pediatric day case surgery have focused on the postoperative pain risk at night, because it becomes the great problem for the parent. Because half of children experience clinically significant pain after discharge according to pain studies done for children (4).
Volatile anesthetics can activate peripheral neurons that play important role on pain perception in postoperative period (3). Zhang et al reported that volatile anesthetics have been demonstrated to have hyperalgesic effects (5). In addition the other studies reported that volatile anesthetic induced pain enhancement was mediated by modulation of central adrenergic and cholinergic transmission (6)(7). Also modulation of 5-Hidroxytriptamine3 receptor-mediated currents by volatile anesthetics may also play a role in their pronociceptin effect (8)(9).
The recovery profile studies comparing IV propofol anesthesia with inhaled anesthetics have shown a better postoperative analgesia with propofol (10)(11). A recent study Tan et al shown that the patients anesthetized with intravenous propofol anesthesia for surgery had less pain than patients anesthetized with sevofluorane (12). A different study by Cheng et al investigating the postoperative analgesic effects of nicotine nasal spray coincidentally found that patients anesthetized with propofol had less postoperative pain than patients anesthetized with isofluorane over the postoperative 24 hours (13).
Animal studies suggested that propofol suppressed nociceptive behavior. Propofol known to have nociceptive effects by activating transient receptor potential ion channel (14)(15) has been demonstrated to have analgesic and antihyperalgesic properties at sedative doses in a human pain model (16) In normal rat model, propofol has direct actions on the dorsal horn neurons of the spinal cord, which played an important role in the processing of sensory information (17) In a rat formalin model, propofol produced antinociceptive effect in a dose-dependent manner (18). Moreover, subhypnotic doses of propofol has been demonstrated to delay and weaken remifentanil induced post-infusion hyperalgesia in human (19).
The objective of this study was to determine (a) whether patients anesthetized with intravenous propofol have less pain compared with sevofluorane for paediatric inguinal hernia and undescended testis operations and (b) whether intravenous propofol anesthesia has better quality of recovery compared with sevofluorane anesthesia in the immediate postoperative period after paediatric inguinal hernia and undescended testis operations.
MATERIAL METHODS After obtaining institutional ethics committee approval and written informed consent, 100 American Society of Anaesthesiologists I-II children, aged between 2 and 12 years undergoing elective surgery for inguinal hernia repair and undescended testis were enrolled in the study. The study used a double-blind methodology with random allocation to the two groups by a computer-generated list.
All patients' parents will be instructed on the use of the Wong-Baker Faces Pain scales for pain assessment before the induction of anesthesia. Both of the hands will be applied Eutectic Mixture of Local Anesthetics Cream (Lidocaine Hydrochloric acid, prilocaine, Astra Zeneca, Istanbul, Turkey) 60 minutes before the operations by the nurse. All the children were premedicated with midazolam hydrochloride 0.6 mg/kg orally; maximum 30 min prior to the surgery and we made sure that the drug was given under the tongue to avoid first liver passage. Patients will be monitored in the operating room. Heart rate (HR) mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) were recorded. Patients will be randomized into 2 groups using a computer-generated random number table: the first group will be inducted with iv propofol (Group P) and after sevofluorane inhalation will continue, the second group (Group S) will be inducted and continued with sevofluorane. Anesthesia was maintained with sevofluorane titrated to a value of 40 bispectrial index.
I.Grup 1: Sevofluorane 8% mask induction and continue with 2% sevofluorane I.Grup 2: Propofol 2.5mg/kg in induction and continue with 2% sevofluorane Fluid therapy was standardized during and after surgery. During surgery, children received lactated Ringer's solution 6 ml/ kg/ h whereas 5% dextrose with electrolytes was given at a rate of 4 ml/ kg/ h in the postoperative period. Induction of anesthesia is performed using oxygen (FiO2 0.33), nitrous oxide (FiO2 0.66), and sevofluorane (increasing concentrations up to 8%) administered by mask. After sevofluorane induction intravenous cannula will be inserted. The other group propofol 2.5mg/kg in induction and continue with 2% sevoflorane. After 0.5 mg/kg rocuronium and 1 mcg/kg fentanyl will be applied before intubation. 5 minutes after induction heart rate, tension arterial, saturation will be recorded. Both of the groups will be maintained with 2% sevofluorane and 40% nitrous oxide. All the operations will be done with the same technique by the same surgeon. After spontaneous breathing , the reverse will be applied as 0.03 mg/kg neostigmine ve 0.01 mg/kg atropine intravenous. After reversal of airway reflexes, the patients will be extubated. After extubation the patients will be in postanesthesia recovery room. Operation time, anesthesia time will be recorded. First eye opening, first verbal command follow, staying time in PACU, first analgesic time, ambulation time, first oral intake time, extermination time will be recorded according to the anesthesia completion time. Completion of the surgery, 20 mg/kg rectal paracetamol will be applied as suppository form. However If VAS≥3 then 20 mg/kg paracetamol will be applied in intravenous form. Heart rate, tension arterial, saturation, respiratory rate, agitation scale, Wong-Baker Faces Pain rating scale for pain will be assessed and recorded. If agitation score≥4 then 1mcg/kg fentanyl will be applied intravenously. Wong-Baker Faces Pain rating scale will be taught to all parents and how to sign according to shapes of the faces of all children (No pain-smiling face to most pain-crying face). Transition from PACU to surgical ward was considered safe when patient had achieved a Modified Aldrete Score 9 for at least 10 min, and SpO2 95% with oxygen 2 l/min or 92% without oxygen, signified recovery of physical, mental, and physiological function to near preanesthetic levels. Furthermore, 10-point analogue scales were used to measure parents' satisfaction with their child's overall anaesthetic and surgical care and satisfaction with their participation in decisionmaking (0 . not at all satisfied, 10 . extremely satisfied). All adverse events (bronchospasm, laryngospasm, desaturation, hypotension, bleeding, reoperation) will be recorded for postoperative 0h(PACU), 10 min, 20 min, 30 min, 40 min, 50 min, 1h, 2h, 4h, 6h, 12h, 24h.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevofluorane | Experimental | Drug: SevofluoraneSevofluorane 8% in induction |
| Propofol | Experimental | Drug: PropofolPropofol 2.5 mg/kg intravenous in induction |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists I-II
- 2-12 years old patients
- Patients for elective inguinal hernia and undescended testis operations.
Key exclusion criteria (8 listed)
- Children with developmental problems
- Cerebral palsy
- Down syndrome
- Inborn errors of metabolism
- A history of epileptic fits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SevofluoraneAlso: SevoraneComparison of different induction drugs and techniques | Drug | Sevofluorane |
| PropofolAlso: pofolComparison of different induction drugs and techniques | Drug | Propofol |
Primary outcome
Postoperative pain
Time frame: Postoperative 24 hours
1 secondary outcome
Postoperative agitation
Time frame: postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2015.
- Results publication: PubMed 19910624Tan T, Bhinder R, Carey M, Briggs L. Day-surgery patients anesthetized with propofol have less postoperative pain than those anesthetized with sevoflurane. Anesth Analg. 2010 Jul;111(1):83-5. doi: 10.1213/ANE.0b013e3181c0ee9e. Epub 2009 Nov 12.
- Results publication: PubMed 22192060Li M, Mei W, Wang P, Yu Y, Qian W, Zhang ZG, Tian YK. Propofol reduces early post-operative pain after gynecological laparoscopy. Acta Anaesthesiol Scand. 2012 Mar;56(3):368-75. doi: 10.1111/j.1399-6576.2011.02603.x. Epub 2011 Dec 23.
- Click here for more information about this study: Clinical Trial of Click here for more information about this study: Clinical Trial of Society for Ambulatory AnesthesiologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selim Turhanoglu, Prof principal investigator
Mustafa Kemal University medicine faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevofluorane and Propofol in people with Hernia, Inguinal and Cryptorchidism, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02110745, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2015.