Liver CancerPhase 3NCT01438476
Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-Controlled Analgesia For Liver and/or Pancreas
A Phase 3 study testing Thoracic Epidural Analgesia (TEA), Questionnaires and Pain Assessment in people with Liver Cancer and Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if there is a difference in patients' quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after surgery on the liver and/or pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Pancreatic Cancer
- What is being tested?
- Thoracic Epidural Analgesia (TEA), Questionnaires and Pain Assessment
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2012to 18 Oct 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing liver and/or pancreatic surgical resection for malignancy at MD Anderson Cancer Center.
- Patients 18 years of age and older. There will be no upper age restriction.
- Patients must sign a study-specific consent form.
- Adequate coagulation function within 30 days of surgery: Platelets >/= 100,000/ml; international normalized ratio (INR) </= 1.5; activated partial thromboplastin time (aPTT) </= 40.
- Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude epidural placement.
Who cannot join
- Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver or pancreatic surgery.
- History of chronic pain, long-term narcotic use or being considered for chronic pain consultation postoperatively.
- Anaphylaxis to local anesthetics or narcotics.
- Previous or current neurologic disease affecting the lower hemithorax or below.
- Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia, except for total intravenous anesthesia (TIVA).
- Technical contraindications to epidural placement: previous thoracic spinal surgery or local skin or soft tissue infection at proposed site for epidural insertion.
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- Ongoing use or planned peri-operative use of anticoagulants (not including deep vein thrombosis (DVT) prophylaxis).
- Known bleeding diathesis or coagulopathy.
- Educational, psychiatric (untreated or poorly controlled schizophrenia, major depression, or bipolar disorder), or communication (language) barrier that would preclude accurate assessment of postoperative pain and/or ability to answer questionnaires (need to be able to read, comprehend, and answer questions).
- Inability to comply with study and/or follow-up procedures.
- Patient refusal to participate in randomization.
- Pregnant women are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 12 consecutive months) must agree to practice adequate contraception and to refrain from breast-feeding, as specified in the informed consent.
- Patients with obvious unresectable disease prior to signing informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient Controlled Analgesia (3:1) in Patients Undergoing Liver and/or Pancreatic Resection
The goal of this clinical research study is to learn if there is a difference in patients' quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after surgery on the liver and/or pancreas. Researchers want to learn which method helps people to recover more completely and more quickly after surgery.
The 2 kinds of pain control are intravenous (IV) pain management and epidural pain management.
Read the detailed description
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. For every participant assigned to Group 1, 3 participants will be assigned to Group 2. This means you are 3 times more likely to be assigned to Group 2 than you are to Group 1.
- Group 1 will receive IV pain management.
- Group 2 will receive epidural pain management.
Group 1:
IV pain management will be given through a needle in your arm. This needle will be placed when you are either in the holding area or in the operating room. You will have this needle placed no matter if you take part in this study or not. The needle is used to give drugs and manage fluids during surgery.
After surgery, your doctor will set the limit for the highest dose of pain medication that you can receive at any time, but you will be able to use a hand-held button to adjust your drug according to the level of pain you may be having.
If your pain is not well controlled, the study staff may decide you can be switched to Group 2 if it seems to be in your best interest.
Group 2:
Epidural pain management will be given through a needle inserted into the space between the covering of your spinal cord and the cord itself. This area is full of fluid and is called the epidural region. The needle will be placed before your surgery, either in the holding area or in the operating room by the doctor that gives your anesthesia.
If your epidural does not work, the study staff may decide you can be switched to Group 1 if it seems to be in your best interest.
Both Groups:
During your surgery, you will have a catheter (sterile flexible tube) placed in an artery. This catheter will be used to provide additional fluid and blood support and to monitor you during surgery. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
During surgery, blood (about 1 tablespoon) will be drawn before you receive anesthesia. This blood will be drawn using one of the IV lines that you already have in place for your surgery. This blood will be tested to look for certain proteins called cytokines that may help researchers to understand how your body is responding to pain and how pain is affecting the healing process.
You will be asked to sign a separate consent form that describes the surgery and its risks in detail. The study staff will also tell you about the standard pain medications, how they will be given, and the possible risks.
After Surgery:
After your surgery, you will go to the Post-Anesthesia Care Unit (PACU) for recovery. You will have a physical exam to check your recovery. Your vital signs will also be measured. You will be asked how you are feeling. Your doctor(s) will decide whether you will go from the PACU to the intensive care unit (ICU), overnight recovery suite, or will be moved to a regular post-surgical recovery floor room, where your recovery will be watched.
On Days 1, 3, and 5 after your surgery, blood (about 1 tablespoon) will be drawn for cytokine testing. This blood will be drawn along with the other routine blood work that you will have after your surgery.
If you are in Group 2, a member of the MD Anderson Pain Service will check your epidural site every day to make sure that it is working and that there are no problems with the area around your epidural. A nurse will also check during each shift (about every 8-10 hours) to see how well you are able to move and how the epidural is affecting your feeling in the area it is supposed to be working in.
In both groups, you will be asked to rate your level of pain management on a scale of 0-10. When you first come out of surgery, this pain rating will happen about every hour. Your pain will also be rated about every hour if you are assigned to the surgical ICU. When you get to your room (overnight recovery or surgical floor), it will happen about every 4 hours. You can use your call bell to let a nurse know if your pain is intolerable between the nurses checks.
Questionnaires:
Before your surgery, you will fill out questionnaires about the pain and your quality of life. This should take about 20 minutes to complete.
From the day after surgery (Day 1) through Day 5, you will also be asked to fill out questionnaires about your recovery and any side effects and symptoms you may be having from the pain medication. This will take about 20-40 minutes.
While you are in the hospital, you will be asked to answer some questions that will measure how quickly you recover from the sedation used during your surgery. Each shift (about every 8-10 hours), a nurse will ask you questions to find out how quickly you are recovering from anesthesia.
Length of Study Participation:
The pain medication or epidural insertion will be stopped early if you are having intolerable side effects or if the medication is not working.
Your participation in the study will be over after Day 5.
This is an investigational study. IV pain management and epidural pain management are FDA approved and commercially available. Randomly assigning you to a type of pain management and comparing the treatments is being done for research purposes only.
Up to 200 patients will be enrolled in this study. All will be enrolled at MD Anderson.
- Conditions
- Liver Cancer, Pancreatic Cancer
- Being tested
- Intravenous Patient-Controlled Analgesia (IVPCA), Thoracic Epidural Analgesia (TEA), Questionnaires, Pain Assessment
- Keywords
- Liver Cancer, Pancreatic Cancer, Thoracic epidural analgesia, TEA, Intravenous patient-controlled analgesia, IVPCA, Pain control, Quality of life, QOL, Surgical resection
- Medical subject headings
- Liver Neoplasms, Pancreatic Neoplasms, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Patient-Controlled Analgesia (IVPCA)Procedure or surgery
Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.
Thoracic Epidural Analgesia (TEA)Procedure or surgery
Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.
QuestionnairesBehavioural
Also called Survey
Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
Pain AssessmentBehavioural
Hourly post surgery rating level of pain on a scale of 0-10.
| Study group | Role | What they receive |
|---|---|---|
| IV Pain Management | Experimental | Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Receives: Procedure: Intravenous Patient-Controlled Analgesia (IVPCA); Behavioral: Questionnaires; Behavioral: Pain Assessment |
| Epidural Pain Management | Experimental | Thoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. Receives: Procedure: Thoracic Epidural Analgesia (TEA); Behavioral: Questionnaires; Behavioral: Pain Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Experience
The Area Under the Curve (AUC) pain score during the first 48 hours after surgery. Post operative pain was measured during the first 48 hours per unit acuity guidelines. Typically this was at a minimum of every four hours yielding an average number of measures during the first 48 hours. The scale is 0-480 low scores are better.
Measured: First 48 hours 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 Sep 2011 (estimated)
- Study start26 Jan 2012
- Primary completion18 Oct 2017
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Nicolas Vauthey, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438476
- Sponsor's protocol ID
- 2011-0146
- Other IDs
- NCI-2011-03284
- Status last verified
- Feb 2020
- First submitted
- 20 Sep 2011
- Last updated
- 12 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cata JP, Velasquez JF, Ramirez MF, Vauthey JN, Gottumukkala V, Conrad C, Kim BJ, Aloia T. Inflammation and pro-resolution inflammation after hepatobiliary surgery. World J Surg Oncol. 2017 Aug 10;15(1):152. doi: 10.1186/s12957-017-1220-6.
PubMed 28807031Aloia TA, Kim BJ, Segraves-Chun YS, Cata JP, Truty MJ, Shi Q, Holmes A, Soliz JM, Popat KU, Rahlfs TF, Lee JE, Wang XS, Morris JS, Gottumukkala VNR, Vauthey JN. A Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-controlled Analgesia After Major Hepatopancreatobiliary Surgery. Ann Surg. 2017 Sep;266(3):545-554. doi: 10.1097/SLA.0000000000002386.
PubMed 28746153
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient Controlled Analgesia (3:1) in Patients Undergoing Liver and/or Pancreatic Resection
- ClinicalTrials.gov ID
- NCT01438476
- Acronym / sponsor ID
- 2011-0146
- Conditions
- Liver Cancer, Pancreatic Cancer
- Keywords
- Liver Cancer, Pancreatic Cancer, Thoracic epidural analgesia, TEA, Intravenous patient-controlled analgesia, IVPCA, Pain control, Quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 26 Jan 2012 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 22 Sep 2011 (estimated)
- Results
- Posted 12 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if there is a difference in patients' quality of recovery if they receive 1 of 2 standard kinds of pain control treatments after surgery on the liver and/or pancreas. Researchers want to learn which method helps people to recover more completely and more quickly after surgery.
The 2 kinds of pain control are intravenous (IV) pain management and epidural pain management.
Detailed description
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. For every participant assigned to Group 1, 3 participants will be assigned to Group 2. This means you are 3 times more likely to be assigned to Group 2 than you are to Group 1.
- Group 1 will receive IV pain management.
- Group 2 will receive epidural pain management.
Group 1:
IV pain management will be given through a needle in your arm. This needle will be placed when you are either in the holding area or in the operating room. You will have this needle placed no matter if you take part in this study or not. The needle is used to give drugs and manage fluids during surgery.
After surgery, your doctor will set the limit for the highest dose of pain medication that you can receive at any time, but you will be able to use a hand-held button to adjust your drug according to the level of pain you may be having.
If your pain is not well controlled, the study staff may decide you can be switched to Group 2 if it seems to be in your best interest.
Group 2:
Epidural pain management will be given through a needle inserted into the space between the covering of your spinal cord and the cord itself. This area is full of fluid and is called the epidural region. The needle will be placed before your surgery, either in the holding area or in the operating room by the doctor that gives your anesthesia.
If your epidural does not work, the study staff may decide you can be switched to Group 1 if it seems to be in your best interest.
Both Groups:
During your surgery, you will have a catheter (sterile flexible tube) placed in an artery. This catheter will be used to provide additional fluid and blood support and to monitor you during surgery. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
During surgery, blood (about 1 tablespoon) will be drawn before you receive anesthesia. This blood will be drawn using one of the IV lines that you already have in place for your surgery. This blood will be tested to look for certain proteins called cytokines that may help researchers to understand how your body is responding to pain and how pain is affecting the healing process.
You will be asked to sign a separate consent form that describes the surgery and its risks in detail. The study staff will also tell you about the standard pain medications, how they will be given, and the possible risks.
After Surgery:
After your surgery, you will go to the Post-Anesthesia Care Unit (PACU) for recovery. You will have a physical exam to check your recovery. Your vital signs will also be measured. You will be asked how you are feeling. Your doctor(s) will decide whether you will go from the PACU to the intensive care unit (ICU), overnight recovery suite, or will be moved to a regular post-surgical recovery floor room, where your recovery will be watched.
On Days 1, 3, and 5 after your surgery, blood (about 1 tablespoon) will be drawn for cytokine testing. This blood will be drawn along with the other routine blood work that you will have after your surgery.
If you are in Group 2, a member of the MD Anderson Pain Service will check your epidural site every day to make sure that it is working and that there are no problems with the area around your epidural. A nurse will also check during each shift (about every 8-10 hours) to see how well you are able to move and how the epidural is affecting your feeling in the area it is supposed to be working in.
In both groups, you will be asked to rate your level of pain management on a scale of 0-10. When you first come out of surgery, this pain rating will happen about every hour. Your pain will also be rated about every hour if you are assigned to the surgical ICU. When you get to your room (overnight recovery or surgical floor), it will happen about every 4 hours. You can use your call bell to let a nurse know if your pain is intolerable between the nurses checks.
Questionnaires:
Before your surgery, you will fill out questionnaires about the pain and your quality of life. This should take about 20 minutes to complete.
From the day after surgery (Day 1) through Day 5, you will also be asked to fill out questionnaires about your recovery and any side effects and symptoms you may be having from the pain medication. This will take about 20-40 minutes.
While you are in the hospital, you will be asked to answer some questions that will measure how quickly you recover from the sedation used during your surgery. Each shift (about every 8-10 hours), a nurse will ask you questions to find out how quickly you are recovering from anesthesia.
Length of Study Participation:
The pain medication or epidural insertion will be stopped early if you are having intolerable side effects or if the medication is not working.
Your participation in the study will be over after Day 5.
This is an investigational study. IV pain management and epidural pain management are FDA approved and commercially available. Randomly assigning you to a type of pain management and comparing the treatments is being done for research purposes only.
Up to 200 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV Pain Management | Experimental | Procedure: Intravenous Patient-Controlled Analgesia (IVPCA), Behavioral: Questionnaires, Behavioral: Pain AssessmentIntravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. |
| Epidural Pain Management | Experimental | Procedure: Thoracic Epidural Analgesia (TEA), Behavioral: Questionnaires, Behavioral: Pain AssessmentThoracic epidurals placed preoperatively in either holding area or in operating room. Hourly post surgery rating level of pain on a scale of 0-10. Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing liver and/or pancreatic surgical resection for malignancy at MD Anderson Cancer Center.
- Patients 18 years of age and older. There will be no upper age restriction.
- Patients must sign a study-specific consent form.
- Adequate coagulation function within 30 days of surgery: Platelets >/= 100,000/ml; international normalized ratio (INR) </= 1.5; activated partial thromboplastin time (aPTT) </= 40.
- Patients must have no fever or evidence of infection or other coexisting medical condition that would preclude epidural placement.
Key exclusion criteria (13 listed)
- Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver or pancreatic surgery.
- History of chronic pain, long-term narcotic use or being considered for chronic pain consultation postoperatively.
- Anaphylaxis to local anesthetics or narcotics.
- Previous or current neurologic disease affecting the lower hemithorax or below.
- Major open abdominal/thoracic surgery in the previous 30 days under general anesthesia, except for total intravenous anesthesia (TIVA).
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 |
|---|---|---|
| Intravenous Patient-Controlled Analgesia (IVPCA)Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures. | Procedure or surgery | IV Pain Management |
| Thoracic Epidural Analgesia (TEA)Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room. | Procedure or surgery | Epidural Pain Management |
| QuestionnairesAlso: SurveyQuestions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes. | Behavioural | Epidural Pain Management, IV Pain Management |
| Pain AssessmentHourly post surgery rating level of pain on a scale of 0-10. | Behavioural | Epidural Pain Management, IV Pain Management |
Primary outcome
Postoperative Pain Experience
Time frame: First 48 hours after surgery
The Area Under the Curve (AUC) pain score during the first 48 hours after surgery. Post operative pain was measured during the first 48 hours per unit acuity guidelines. Typically this was at a minimum of every four hours yielding an average number of measures during the first 48 hours. The scale is 0-480 low scores are better.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28807031Cata JP, Velasquez JF, Ramirez MF, Vauthey JN, Gottumukkala V, Conrad C, Kim BJ, Aloia T. Inflammation and pro-resolution inflammation after hepatobiliary surgery. World J Surg Oncol. 2017 Aug 10;15(1):152. doi: 10.1186/s12957-017-1220-6.
- Derived from this study: PubMed 28746153Aloia TA, Kim BJ, Segraves-Chun YS, Cata JP, Truty MJ, Shi Q, Holmes A, Soliz JM, Popat KU, Rahlfs TF, Lee JE, Wang XS, Morris JS, Gottumukkala VNR, Vauthey JN. A Randomized Controlled Trial of Postoperative Thoracic Epidural Analgesia Versus Intravenous Patient-controlled Analgesia After Major Hepatopancreatobiliary Surgery. Ann Surg. 2017 Sep;266(3):545-554. doi: 10.1097/SLA.0000000000002386.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Jean-Nicolas Vauthey, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thoracic Epidural Analgesia (TEA), Questionnaires and Pain Assessment in people with Liver Cancer and Pancreatic Cancer, run by M.D. Anderson Cancer Center 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 5 inclusion and 13 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 12 Feb 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Experience (time frame: First 48 hours after surgery). 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 NCT01438476, 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 12 Feb 2020.