PainNCT01731873
Patient Controlled Analgesia Pharmacogenetic Study
An observational study of Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to identify factors and genes (the nucleic acid material that determines the makeup of the human body) that may be associated with acute and chronic post-surgical pain as well as develop pharmacometric models for response to opioids, like morphine and hydromorphone. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pain
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2012to 30 Apr 2019
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children (weighing at least 5 kg, and up to and including 18 year olds) undergoing surgery requiring postoperative Patient Controlled Analgesia (PCA) or PCA by Proxy with opioids (P/NCA), shall be eligible for the study, if inclusion/exclusion criteria are met.
Who may be able to join
- Children up to and including the age of 18 years;
- Children weighing at least 5kg at time of surgery; and
- Children scheduled for surgery requiring opioids PCA or PCA by proxy for postoperative pain relief.
Who cannot join
- Children with a history of active liver or renal dysfunction (generally indicated by current abnormal lab results);
- Patients with severe respiratory problems (indicated by an ASA rating > 4, or oxygen/CPAP/BiPAP dependence);
- Children with recent chronic preoperative pain, especially those requiring opioids or nerve pain medications within the last 6 months prior to surgery;
- Children who are anticipated to receive ketamine (i.e., injection, infusion, IM) or dexmedetomidine/sufentanil/lidocaine infusions perioperatively;
- Children with BMI > 35;
- Children with certain genetic diseases or chromosomal abnormalities known to affect pain perception and/or breathing; and
- Non-English speaking patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Non-Interventional Pharmacogenetic Study of Patient / Proxy Controlled Analgesia in Children Undergoing Surgery
The purpose of this research study is to identify factors and genes (the nucleic acid material that determines the makeup of the human body) that may be associated with acute and chronic post-surgical pain as well as develop pharmacometric models for response to opioids, like morphine and hydromorphone. While children undergioing different surgeries will be recruited for acute outcomes, children undergoing spine fusion will be followed for 10-12 months for evaluation of psychological and genomic factors affecting chronic post-surgical pain, with a goal of identifying genetic and epigenetic risk models for prediction of acute and chronic post-surgical pain. Although opioids are used every day, some children have bad reactions from their use, like breathing problems, sedation, etc. The investigators want to study factors that may be associated with pain sensitivity, opioid requirements after surgery, their metabolism, efficacy and their side-effects. The investigators expect that the information obtained in this research study will help to develop effective, safer, and tailored treatment options in the future.
Read the detailed description
Pain management after surgery is not optimal partly due to great interindividual variability in pain perception and coping. This also can lead to persistent pain beyond the healing period and disability. Up to two-thirds of the inter-individual variability result from genetic variations in pain perception as well as response to the pain medicine. The investigators aim to identify genomic (genetic/epigenetic), psychological and drug profiles contributing to this variability. Opioids are the mainstay for treatment of postoperative pain in children. Experience dictates that opioids have narrow therapeutic indices and large inter-patient variability in response. This leads to serious side effects like respiratory depression in up to 50% of children undergoing invasive surgery, which can be fatal. It is evident that there are particular children who are more susceptible to suffering side effects and having inadequate pain relief from opioids.
It is hypothesized that much of the genetic variability can be explained by gene function which is modulated by a) Single Nucleotide Polymorphisms (SNPs) in genes that encode proteins involved in pain perception, opioid transport/metabolism (pharmacokinetics), and opioid receptor signaling (pharmacodynamics); b) epigenetics which modify gene expression without structural changes to the DNA, and c) genes that influence psychological factors.
Identifying genetic and non-genetic predictors for this susceptibility is vital for safe and effective analgesia in children. This is a critical knowledge gap in medical literature that significantly impacts pediatric pain management. The investigators' central hypothesis is that specific genetic polymorphisms in genes involved in pain perception, opioid transport, and opioid receptor signaling pathways contribute significantly to pain sensitivity, opioid side-effects, and analgesic efficacy in children.
The choice and dosing of opioids and pain management approaches have thus far been largely empirical, with a frequent need to switch medications, strategies and alter doses due to inherent differences in individuals. By this study, the investigators hope to develop preemptive approaches and drug targets that can be targeted to individual risk and genomic-psychosocial profiles. The study will help determine the 'right' doses of the 'right' opioids for optimized and safe postoperative analgesia in children. This will be done by first building population pharmacokinetic and pharmacodynamic models for opioid concentration-exposure and then investigating covariates.
Given the unexplored nature of this complex phenomenon, The investigators propose a comprehensive study to evaluate gene, drug, and surgical interactions, in a large sample of 650 children undergoing different surgeries, requiring patient controlled analgesia with opioids.
The investigators' long term goal is to develop more effective, safer, and tailored pediatric opioid analgesia, by contributing to better understanding of the underlying genetic basis for variations in the sensitivity to pain, pain relief, and development of adverse effects from the extended use of postoperative intravenous opioids in children.
The data collected will include acute and long-term pain data, opioid doses, incidence of side-effects of opioids - including respiratory depression, sedation, vomiting, and itching, and blood samples for genetic and pharmacometric analyses. Data analysis will use advanced logistic regression techniques to uncover the association between the SNP variants and the response to specific opioids following various surgeries.
- Conditions
- Pain
- Keywords
- postoperative pain, children, pharmacogenetic, opioid adverse effects, respiratory depression, analgesia, genetic polymorphisms, chronic postsurgical pain
- Medical subject headings
- Pain, Pain, Postoperative, Respiratory Insufficiency, Agnosia
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Post-surgical pain scores at rest and on mobilization, opioid requirements/48 hours
Measured: 48 hours post-operatively
Chronic post-surgical pain
Pain scores several months after surgery
Measured: 6-12 months after surgery
Secondary outcomes (2)
Opioid pharmacometrics
Drug Concentration-Exposure curves
Measured: 24-48 hours postoperatively
Chronic post-surgical disability
Functional disability scores
Measured: 6-12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study start17 Jan 2012
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (94)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vidya Chidambaran, MD, Principal investigator, Cincinnati Childrens Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01731873
- Sponsor's protocol ID
- 2010-2268
- Status last verified
- Sep 2020
- First submitted
- 19 Nov 2012
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified data may be shared with additional internal or external data warehouses/investigators. These include but are not limited to the i2b2-Research Data Warehouse protocol at CCHMC (IRB 2008-0834) for the purpose of linking this data to a de-identified copy of the participant's electronic medical record via an i2b2 database. The resulting de-identified i2b2 database will not be part of this research; but will be used to explore secondary phenotypes in future research studies and documented in the NIH-db-GaP (Database of Genotypes and Phenotypes).
Publications
Sadhasivam S, Boat A, Mahmoud M. Comparison of patient-controlled analgesia with and without dexmedetomidine following spine surgery in children. J Clin Anesth. 2009 Nov;21(7):493-501. doi: 10.1016/j.jclinane.2008.12.017.
PubMed 20006257Voepel-Lewis T, Marinkovic A, Kostrzewa A, Tait AR, Malviya S. The prevalence of and risk factors for adverse events in children receiving patient-controlled analgesia by proxy or patient-controlled analgesia after surgery. Anesth Analg. 2008 Jul;107(1):70-5. doi: 10.1213/ane.0b013e318172fa9e.
PubMed 18635469Aubrun F, Monsel S, Langeron O, Coriat P, Riou B. Postoperative titration of intravenous morphine. Eur J Anaesthesiol. 2001 Mar;18(3):159-65. doi: 10.1046/j.0265-0215.2000.00796.x.
PubMed 11298174Ross JR, Rutter D, Welsh K, Joel SP, Goller K, Wells AU, Du Bois R, Riley J. Clinical response to morphine in cancer patients and genetic variation in candidate genes. Pharmacogenomics J. 2005;5(5):324-36. doi: 10.1038/sj.tpj.6500327.
PubMed 16103897Ikeda K, Ide S, Han W, Hayashida M, Uhl GR, Sora I. How individual sensitivity to opiates can be predicted by gene analyses. Trends Pharmacol Sci. 2005 Jun;26(6):311-7. doi: 10.1016/j.tips.2005.04.001.
PubMed 15925706White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. No abstract available.
PubMed 20010418Silverstein JH, Rieders MF, McMullin M, Schulman S, Zahl K. An analysis of the duration of fentanyl and its metabolites in urine and saliva. Anesth Analg. 1993 Mar;76(3):618-21. doi: 10.1213/00000539-199303000-00030.
PubMed 8452277Feierman DE, Lasker JM. Metabolism of fentanyl, a synthetic opioid analgesic, by human liver microsomes. Role of CYP3A4. Drug Metab Dispos. 1996 Sep;24(9):932-9.
PubMed 8886601Zanger UM, Turpeinen M, Klein K, Schwab M. Functional pharmacogenetics/genomics of human cytochromes P450 involved in drug biotransformation. Anal Bioanal Chem. 2008 Nov;392(6):1093-108. doi: 10.1007/s00216-008-2291-6. Epub 2008 Aug 10.
PubMed 18695978Zhang W, Chang YZ, Kan QC, Zhang LR, Li ZS, Lu H, Wang ZY, Chu QJ, Zhang J. CYP3A4*1G genetic polymorphism influences CYP3A activity and response to fentanyl in Chinese gynecologic patients. Eur J Clin Pharmacol. 2010 Jan;66(1):61-6. doi: 10.1007/s00228-009-0726-4. Epub 2009 Sep 26.
PubMed 19784640D'Arcy Y. One opioid does not fit all. Nurse Pract. 2007 Nov;32(11):7-8. doi: 10.1097/01.NPR.0000298262.47655.14. No abstract available.
PubMed 18075450Hirota T, Ieiri I, Takane H, Sano H, Kawamoto K, Aono H, Yamasaki A, Takeuchi H, Masada M, Shimizu E, Higuchi S, Otsubo K. Sequence variability and candidate gene analysis in two cancer patients with complex clinical outcomes during morphine therapy. Drug Metab Dispos. 2003 May;31(5):677-80. doi: 10.1124/dmd.31.5.677.
PubMed 12695358Sadhasivam S, Cohen LL, Szabova A, Varughese A, Kurth CD, Willging P, Wang Y, Nick TG, Gunter J. Real-time assessment of perioperative behaviors and prediction of perioperative outcomes. Anesth Analg. 2009 Mar;108(3):822-6. doi: 10.1213/ane.0b013e318195c115.
PubMed 19224789Sawyer MB, Innocenti F, Das S, Cheng C, Ramirez J, Pantle-Fisher FH, Wright C, Badner J, Pei D, Boyett JM, Cook E Jr, Ratain MJ. A pharmacogenetic study of uridine diphosphate-glucuronosyltransferase 2B7 in patients receiving morphine. Clin Pharmacol Ther. 2003 Jun;73(6):566-74. doi: 10.1016/S0009-9236(03)00053-5.
PubMed 12811366Takeda S, Ishii Y, Iwanaga M, Mackenzie PI, Nagata K, Yamazoe Y, Oguri K, Yamada H. Modulation of UDP-glucuronosyltransferase function by cytochrome P450: evidence for the alteration of UGT2B7-catalyzed glucuronidation of morphine by CYP3A4. Mol Pharmacol. 2005 Mar;67(3):665-72. doi: 10.1124/mol.104.007641. Epub 2004 Dec 20.
PubMed 15611481
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Pharmacogenetic Study of Patient / Proxy Controlled Analgesia in Children Undergoing Surgery
- ClinicalTrials.gov ID
- NCT01731873
- Acronym / sponsor ID
- 2010-2268
- Conditions
- Pain
- Keywords
- postoperative pain, children, pharmacogenetic, opioid adverse effects, respiratory depression, analgesia, genetic polymorphisms, chronic postsurgical pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 17 Jan 2012 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 22 Nov 2012 (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 purpose of this research study is to identify factors and genes (the nucleic acid material that determines the makeup of the human body) that may be associated with acute and chronic post-surgical pain as well as develop pharmacometric models for response to opioids, like morphine and hydromorphone. While children undergioing different surgeries will be recruited for acute outcomes, children undergoing spine fusion will be followed for 10-12 months for evaluation of psychological and genomic factors affecting chronic post-surgical pain, with a goal of identifying genetic and epigenetic risk models for prediction of acute and chronic post-surgical pain. Although opioids are used every day, some children have bad reactions from their use, like breathing problems, sedation, etc. The investigators want to study factors that may be associated with pain sensitivity, opioid requirements after surgery, their metabolism, efficacy and their side-effects. The investigators expect that the information obtained in this research study will help to develop effective, safer, and tailored treatment options in the future.
Detailed description
Pain management after surgery is not optimal partly due to great interindividual variability in pain perception and coping. This also can lead to persistent pain beyond the healing period and disability. Up to two-thirds of the inter-individual variability result from genetic variations in pain perception as well as response to the pain medicine. The investigators aim to identify genomic (genetic/epigenetic), psychological and drug profiles contributing to this variability. Opioids are the mainstay for treatment of postoperative pain in children. Experience dictates that opioids have narrow therapeutic indices and large inter-patient variability in response. This leads to serious side effects like respiratory depression in up to 50% of children undergoing invasive surgery, which can be fatal. It is evident that there are particular children who are more susceptible to suffering side effects and having inadequate pain relief from opioids.
It is hypothesized that much of the genetic variability can be explained by gene function which is modulated by a) Single Nucleotide Polymorphisms (SNPs) in genes that encode proteins involved in pain perception, opioid transport/metabolism (pharmacokinetics), and opioid receptor signaling (pharmacodynamics); b) epigenetics which modify gene expression without structural changes to the DNA, and c) genes that influence psychological factors.
Identifying genetic and non-genetic predictors for this susceptibility is vital for safe and effective analgesia in children. This is a critical knowledge gap in medical literature that significantly impacts pediatric pain management. The investigators' central hypothesis is that specific genetic polymorphisms in genes involved in pain perception, opioid transport, and opioid receptor signaling pathways contribute significantly to pain sensitivity, opioid side-effects, and analgesic efficacy in children.
The choice and dosing of opioids and pain management approaches have thus far been largely empirical, with a frequent need to switch medications, strategies and alter doses due to inherent differences in individuals. By this study, the investigators hope to develop preemptive approaches and drug targets that can be targeted to individual risk and genomic-psychosocial profiles. The study will help determine the 'right' doses of the 'right' opioids for optimized and safe postoperative analgesia in children. This will be done by first building population pharmacokinetic and pharmacodynamic models for opioid concentration-exposure and then investigating covariates.
Given the unexplored nature of this complex phenomenon, The investigators propose a comprehensive study to evaluate gene, drug, and surgical interactions, in a large sample of 650 children undergoing different surgeries, requiring patient controlled analgesia with opioids.
The investigators' long term goal is to develop more effective, safer, and tailored pediatric opioid analgesia, by contributing to better understanding of the underlying genetic basis for variations in the sensitivity to pain, pain relief, and development of adverse effects from the extended use of postoperative intravenous opioids in children.
The data collected will include acute and long-term pain data, opioid doses, incidence of side-effects of opioids - including respiratory depression, sedation, vomiting, and itching, and blood samples for genetic and pharmacometric analyses. Data analysis will use advanced logistic regression techniques to uncover the association between the SNP variants and the response to specific opioids following various surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children (weighing at least 5 kg, and up to and including 18 year olds) undergoing surgery requiring postoperative Patient Controlled Analgesia (PCA) or PCA by Proxy with opioids (P/NCA), shall be eligible for the study, if inclusion/exclusion criteria are met.
Key inclusion criteria (3 listed)
- Children up to and including the age of 18 years;
- Children weighing at least 5kg at time of surgery; and
- Children scheduled for surgery requiring opioids PCA or PCA by proxy for postoperative pain relief.
Key exclusion criteria (7 listed)
- Children with a history of active liver or renal dysfunction (generally indicated by current abnormal lab results);
- Patients with severe respiratory problems (indicated by an ASA rating > 4, or oxygen/CPAP/BiPAP dependence);
- Children with recent chronic preoperative pain, especially those requiring opioids or nerve pain medications within the last 6 months prior to surgery;
- Children who are anticipated to receive ketamine (i.e., injection, infusion, IM) or dexmedetomidine/sufentanil/lidocaine infusions perioperatively;
- Children with BMI > 35;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Post-operative pain
Time frame: 48 hours post-operatively
Post-surgical pain scores at rest and on mobilization, opioid requirements/48 hours
Chronic post-surgical pain
Time frame: 6-12 months after surgery
Pain scores several months after surgery
2 secondary outcomes
Opioid pharmacometrics
Time frame: 24-48 hours postoperatively
Chronic post-surgical disability
Time frame: 6-12 months after surgery
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 3 Sep 2020.
- Background: PubMed 20006257Sadhasivam S, Boat A, Mahmoud M. Comparison of patient-controlled analgesia with and without dexmedetomidine following spine surgery in children. J Clin Anesth. 2009 Nov;21(7):493-501. doi: 10.1016/j.jclinane.2008.12.017.
- Background: PubMed 18635469Voepel-Lewis T, Marinkovic A, Kostrzewa A, Tait AR, Malviya S. The prevalence of and risk factors for adverse events in children receiving patient-controlled analgesia by proxy or patient-controlled analgesia after surgery. Anesth Analg. 2008 Jul;107(1):70-5. doi: 10.1213/ane.0b013e318172fa9e.
- Background: PubMed 11298174Aubrun F, Monsel S, Langeron O, Coriat P, Riou B. Postoperative titration of intravenous morphine. Eur J Anaesthesiol. 2001 Mar;18(3):159-65. doi: 10.1046/j.0265-0215.2000.00796.x.
- Background: PubMed 16103897Ross JR, Rutter D, Welsh K, Joel SP, Goller K, Wells AU, Du Bois R, Riley J. Clinical response to morphine in cancer patients and genetic variation in candidate genes. Pharmacogenomics J. 2005;5(5):324-36. doi: 10.1038/sj.tpj.6500327.
- Background: PubMed 15925706Ikeda K, Ide S, Han W, Hayashida M, Uhl GR, Sora I. How individual sensitivity to opiates can be predicted by gene analyses. Trends Pharmacol Sci. 2005 Jun;26(6):311-7. doi: 10.1016/j.tips.2005.04.001.
- Background: PubMed 20010418White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. No abstract available.
- Background: PubMed 8452277Silverstein JH, Rieders MF, McMullin M, Schulman S, Zahl K. An analysis of the duration of fentanyl and its metabolites in urine and saliva. Anesth Analg. 1993 Mar;76(3):618-21. doi: 10.1213/00000539-199303000-00030.
- Background: PubMed 8886601Feierman DE, Lasker JM. Metabolism of fentanyl, a synthetic opioid analgesic, by human liver microsomes. Role of CYP3A4. Drug Metab Dispos. 1996 Sep;24(9):932-9.
- Background: PubMed 18695978Zanger UM, Turpeinen M, Klein K, Schwab M. Functional pharmacogenetics/genomics of human cytochromes P450 involved in drug biotransformation. Anal Bioanal Chem. 2008 Nov;392(6):1093-108. doi: 10.1007/s00216-008-2291-6. Epub 2008 Aug 10.
- Background: PubMed 19784640Zhang W, Chang YZ, Kan QC, Zhang LR, Li ZS, Lu H, Wang ZY, Chu QJ, Zhang J. CYP3A4*1G genetic polymorphism influences CYP3A activity and response to fentanyl in Chinese gynecologic patients. Eur J Clin Pharmacol. 2010 Jan;66(1):61-6. doi: 10.1007/s00228-009-0726-4. Epub 2009 Sep 26.
- Background: PubMed 18075450D'Arcy Y. One opioid does not fit all. Nurse Pract. 2007 Nov;32(11):7-8. doi: 10.1097/01.NPR.0000298262.47655.14. No abstract available.
- Background: PubMed 12695358Hirota T, Ieiri I, Takane H, Sano H, Kawamoto K, Aono H, Yamasaki A, Takeuchi H, Masada M, Shimizu E, Higuchi S, Otsubo K. Sequence variability and candidate gene analysis in two cancer patients with complex clinical outcomes during morphine therapy. Drug Metab Dispos. 2003 May;31(5):677-80. doi: 10.1124/dmd.31.5.677.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with additional internal or external data warehouses/investigators. These include but are not limited to the i2b2-Research Data Warehouse protocol at CCHMC (IRB 2008-0834) for the purpose of linking this data to a de-identified copy of the participant's electronic medical record via an i2b2 database. The resulting de-identified i2b2 database will not be part of this research; but will be used to explore secondary phenotypes in future research studies and documented in the NIH-db-GaP (Database of Genotypes and Phenotypes).
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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.
Vidya Chidambaran, MD principal investigator
Cincinnati Childrens Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
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 7 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 3 Sep 2020. 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 United States. 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.
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?
Post-operative pain (time frame: 48 hours post-operatively). The study lists 2 primary outcomes in all. 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 NCT01731873, which also lists 94 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 3 Sep 2020.