Postoperative PainPhase 4PAINNCT02111746
PAIN - Postoperative Analgesia INvestigation
A Phase 4 study testing Exparel and Bupivacaine hydrochloride in people with Postoperative Pain, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of the intraoperative injection of prolonged acting (liposomal) bupivacaine in postoperative pain control after truncal surgical incisions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Exparel and Bupivacaine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2013to 30 Jun 2017
- Phase
- Phase 4
- 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
- 18 years-old or older, and
- Sternotomy, thoracotomy, laparotomy or mini-thoracotomy incision is planned
- There is reasonable expectation that the patient will be extubated within 24 hours after surgery
Who cannot join
- The patient has a known allergy to morphine or any opioid
- The patient has a known chronic pain disorder or takes daily opioid medication > 1 month prior to surgery
- There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion
- High postoperative morbidity index based on preoperative assessment, such as, low likelihood of extubation within 24 hours, extensive thoracoabdominal aortic aneurysm (Extent 2 TAAA), preoperative renal insufficiency/failure, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
Houston, Texas, 77030
About this study
Official title: A Prospective Randomized-controlled Study on Effectiveness of Extended-release Liposomal Bupivacaine in Postoperative Pain Control
The purpose of this study is to assess the efficacy of the intraoperative injection of prolonged acting (liposomal) bupivacaine in postoperative pain control after truncal surgical incisions.
Read the detailed description
Study Design:
This is a prospective, single-institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing bupivacaine liposomal injectable suspension (Exparel®) versus regular bupivacaine hydrochloride (HCl).
Procedure:
In patients aged 18 and over who require sternotomy, thoracotomy, mini-thoracotomy, or laparotomy incisions will be screened and consented for potential enrollment. Patients will be randomized following consenting to either Exparel® or regular bupivacaine hydrochloride group.
Course of Study:
The study will accrue patients over the course of 4 years.
Enrollment:
Enrollment will consist of all adult patients aged 18 and over undergoing surgical procedures requiring sternotomy, thoracotomy, mini-thoracotomy, or laparotomy incisions. Patients will be screened and consented preoperatively. If the patient is deemed eligible and consents to participate, randomization will occur and the patient will be considered enrolled.
Recruitment:
The target for enrollment will be 280 patients (the study target sample size per power analysis, but actual enrollment will be greater (330 patients) to account for exclusions for various reasons in order to achieve the target recruitment).
Risks:
There is a small increased risk to the patients by participating in the study in addition to a possible chance of breach in patient confidentiality as the study involves evaluation of an FDA-approved drug. As detailed in the informed consent, the subjects are at risk of developing adverse effects from Exparel®, described on the drug packet insert and from HCl Bupivacaine, also described on the drug packet insert. The investigators do not expect any additional physical risks other than an unintentional disclosure of sensitive patient health information.
Data Safety Monitoring:
As the Principal Investigator of this study, Dr. Charlton-Ouw from the Department of Cardiothoracic and Vascular Surgery at The University of Texas at Houston Medical School will conduct the data safety monitoring of this study. He will annually meet with all other co-investigators to review the patients enrolled in this study. As part of the data safety monitoring plan, all patients enrolled until that point in time would be unblinded in order to review the outcomes. Additionally, in view of the uncertainty attached to the treatment effects in this heterogeneous population, owing to limited currently available data, an independent Data Safety Monitoring Committee, will oversee the progress of the trial.
IND#:
The drugs that will be used are already approved by the FDA and do not have IND/IDE#
Proposed Funding Source:
The study is internally funded and is investigator-initiated.
Communication of Study Results:
The communication of study results will occur only between authorized individuals who are listed to take part in the study through our department. The individuals who will take part in the study will acknowledge and adhere to the importance of patient safety and the protection of their private information. The results of this study will be analyzed and published after the approval of the principal investigator, co-investigators, and biostatistician in a peer-reviewed scientific journal and/or presented at an international/national scientific conference or meeting regardless of outcome.
- Conditions
- Postoperative Pain
- Being tested
- Exparel, Bupivacaine hydrochloride, Patient Controlled Analgesia (PCA)
- Keywords
- Postoperative pain, sternotomy, laparotomy, thoracotomy, mini-thoracotomy, truncal surgical incisions, local anaesthetics, bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
Also called bupivacaine liposomal injectable suspension (Exparel®)
Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Bupivacaine hydrochlorideDrug
Also called Regular Bupivacaine
Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
Patient Controlled Analgesia (PCA)Drug
Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
| Study group | Role | What they receive |
|---|---|---|
| Exparel® | Experimental | Patients in this group will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA). Exparel® is an FDA-approved bupivacaine liposome injectable suspension produced by Pacira Pharmaceuticals. Receives: Drug: Exparel; Drug: Patient Controlled Analgesia (PCA) |
| Regular Bupivacaine | Active comparator | Patients in this group will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension. The standard non-liposomal bupivacaine will be from Hospira pharmaceuticals Receives: Drug: Bupivacaine hydrochloride; Drug: Patient Controlled Analgesia (PCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").
Measured: postoperative day 1
Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").
Measured: postoperative day 2
Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").
Measured: postoperative day 3
Postoperative Pain as Assessed by a Five-point Satisfaction Scale
The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).
Measured: postoperative day 1
Postoperative Pain as Assessed by a Five-point Satisfaction Scale
The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).
Measured: postoperative day 2
Postoperative Pain as Assessed by a Five-point Satisfaction Scale
The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).
Measured: postoperative day 3
Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").
Measured: postoperative day 1
Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").
Measured: postoperative day 2
Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").
Measured: postoperative day 3
Secondary outcomes (5)
Overall Opioid Use
The total amount in mg of opioid medication consumed through 12, 24, 36, 48, 60, and 72 hours after surgery will be assessed.
Measured: Over the first 72 hours after surgery
Mean Length of Hospital Stay
Indirect outcome measure to assess the adequacy of postoperative pain control as an indicator of improvement in healing period, patient participation in physical therapy and faster patient mobilization, and overall health care cost
Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Change From Baseline in Quality of Life
The impact of pain on patient's quality of life will be assessed through a brief pain inventory (BPI). In addition, the 5-point scale analgesia satisfaction survey will be used along with the BPI to assess patient satisfaction and quality of life.
Measured: Will be assessed preoperatively, on the first post-op day (POD 1), on POD2, and POD 3
Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours
Measured: 72 hours after surgery
Hospital Cost for Patient Care During Hospitalization
Hospital cost for patient care during hospitalization will be estimated from hospital charges and financial records.
Measured: duration of hospital stay, an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study start20 Nov 2013
- Primary completion3 May 2017
- Study completion30 Jun 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 (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, blinded, controlled randomized clinical trial with 2-armed parallel-group sequential design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristofer Charlton-Ouw, The University of Texas Health Science Center, Houston
- Investigators
- Kristofer M Charlton-Ouw, MD FACS, Principal investigator, University of Texas Health Science Center, Department of Cardiothoracic and Vascular Surgery, UT Medical School at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111746
- Sponsor's protocol ID
- CTVS-KC02
- Other IDs
- HSC-MS-13-0620
- Acronym
- PAIN
- Status last verified
- Sep 2018
- First submitted
- 2 Apr 2014
- Last updated
- 16 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sandhu HK, Miller CC 3rd, Tanaka A, Estrera AL, Charlton-Ouw KM. Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e210753. doi: 10.1001/jamanetworkopen.2021.0753.
PubMed 33724391
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized-controlled Study on Effectiveness of Extended-release Liposomal Bupivacaine in Postoperative Pain Control
- ClinicalTrials.gov ID
- NCT02111746
- Acronym / sponsor ID
- PAIN / CTVS-KC02
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, sternotomy, laparotomy, thoracotomy, mini-thoracotomy, truncal surgical incisions, local anaesthetics, bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 20 Nov 2013 (actual)
- Primary completion
- 3 May 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Posted 16 Oct 2018
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 study is to assess the efficacy of the intraoperative injection of prolonged acting (liposomal) bupivacaine in postoperative pain control after truncal surgical incisions.
Detailed description
Study Design:
This is a prospective, single-institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing bupivacaine liposomal injectable suspension (Exparel®) versus regular bupivacaine hydrochloride (HCl).
Procedure:
In patients aged 18 and over who require sternotomy, thoracotomy, mini-thoracotomy, or laparotomy incisions will be screened and consented for potential enrollment. Patients will be randomized following consenting to either Exparel® or regular bupivacaine hydrochloride group.
Course of Study:
The study will accrue patients over the course of 4 years.
Enrollment:
Enrollment will consist of all adult patients aged 18 and over undergoing surgical procedures requiring sternotomy, thoracotomy, mini-thoracotomy, or laparotomy incisions. Patients will be screened and consented preoperatively. If the patient is deemed eligible and consents to participate, randomization will occur and the patient will be considered enrolled.
Recruitment:
The target for enrollment will be 280 patients (the study target sample size per power analysis, but actual enrollment will be greater (330 patients) to account for exclusions for various reasons in order to achieve the target recruitment).
Risks:
There is a small increased risk to the patients by participating in the study in addition to a possible chance of breach in patient confidentiality as the study involves evaluation of an FDA-approved drug. As detailed in the informed consent, the subjects are at risk of developing adverse effects from Exparel®, described on the drug packet insert and from HCl Bupivacaine, also described on the drug packet insert. The investigators do not expect any additional physical risks other than an unintentional disclosure of sensitive patient health information.
Data Safety Monitoring:
As the Principal Investigator of this study, Dr. Charlton-Ouw from the Department of Cardiothoracic and Vascular Surgery at The University of Texas at Houston Medical School will conduct the data safety monitoring of this study. He will annually meet with all other co-investigators to review the patients enrolled in this study. As part of the data safety monitoring plan, all patients enrolled until that point in time would be unblinded in order to review the outcomes. Additionally, in view of the uncertainty attached to the treatment effects in this heterogeneous population, owing to limited currently available data, an independent Data Safety Monitoring Committee, will oversee the progress of the trial.
IND#:
The drugs that will be used are already approved by the FDA and do not have IND/IDE#
Proposed Funding Source:
The study is internally funded and is investigator-initiated.
Communication of Study Results:
The communication of study results will occur only between authorized individuals who are listed to take part in the study through our department. The individuals who will take part in the study will acknowledge and adhere to the importance of patient safety and the protection of their private information. The results of this study will be analyzed and published after the approval of the principal investigator, co-investigators, and biostatistician in a peer-reviewed scientific journal and/or presented at an international/national scientific conference or meeting regardless of outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, blinded, controlled randomized clinical trial with 2-armed parallel-group sequential design
| Arm | Type | Receives |
|---|---|---|
| Exparel® | Experimental | Drug: Exparel, Drug: Patient Controlled Analgesia (PCA)Patients in this group will receive will receive the study drug [bupivacaine liposomal injectable suspension (Exparel®)] and Patient Controlled Analgesia (PCA). Exparel® is an FDA-approved bupivacaine liposome injectable suspension produced by Pacira Pharmaceuticals. |
| Regular Bupivacaine | Active comparator | Drug: Bupivacaine hydrochloride, Drug: Patient Controlled Analgesia (PCA)Patients in this group will receive will receive the standard regular bupivacaine hydrochloride (HCl) and PCA. Bupivacaine HCl is an FDA-approved injectable suspension. The standard non-liposomal bupivacaine will be from Hospira pharmaceuticals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years-old or older, and
- Sternotomy, thoracotomy, laparotomy or mini-thoracotomy incision is planned
- There is reasonable expectation that the patient will be extubated within 24 hours after surgery
Key exclusion criteria (4 listed)
- The patient has a known allergy to morphine or any opioid
- The patient has a known chronic pain disorder or takes daily opioid medication > 1 month prior to surgery
- There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion
- High postoperative morbidity index based on preoperative assessment, such as, low likelihood of extubation within 24 hours, extensive thoracoabdominal aortic aneurysm (Extent 2 TAAA), preoperative renal insufficiency/failure, etc.
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 |
|---|---|---|
| ExparelAlso: bupivacaine liposomal injectable suspension (Exparel®)Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure. | Drug | Exparel® |
| Bupivacaine hydrochlorideAlso: Regular BupivacaineParticipants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure. | Drug | Regular Bupivacaine |
| Patient Controlled Analgesia (PCA)Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day | Drug | Exparel®, Regular Bupivacaine |
Primary outcome
Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
Time frame: postoperative day 1
The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").
Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
Time frame: postoperative day 2
The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").
Postoperative Pain as Assessed by a Numeric Pain Scale (NPS)
Time frame: postoperative day 3
The Numeric Pain Scale (NPS) ranges from 0 ("no pain") to 10 ("worst possible pain").
Postoperative Pain as Assessed by a Five-point Satisfaction Scale
Time frame: postoperative day 1
The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).
Postoperative Pain as Assessed by a Five-point Satisfaction Scale
Time frame: postoperative day 2
The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).
Postoperative Pain as Assessed by a Five-point Satisfaction Scale
Time frame: postoperative day 3
The 5-point satisfaction scale ranges from 1 (extremely dissatisfied) to 5 (extremely satisfied).
Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
Time frame: postoperative day 1
The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").
Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
Time frame: postoperative day 2
The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").
Postoperative Pain as Assessed by the Brief Pain Inventory (BPI)
Time frame: postoperative day 3
The Brief Pain Inventory (BPI) ranges from 0 ("no pain") to 10 ("worst pain you can imagine").
5 secondary outcomes
Overall Opioid Use
Time frame: Over the first 72 hours after surgery
Mean Length of Hospital Stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Change From Baseline in Quality of Life
Time frame: Will be assessed preoperatively, on the first post-op day (POD 1), on POD2, and POD 3
Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours
Time frame: 72 hours after surgery
Hospital Cost for Patient Care During Hospitalization
Time frame: duration of hospital stay, an expected average of 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33724391Sandhu HK, Miller CC 3rd, Tanaka A, Estrera AL, Charlton-Ouw KM. Effectiveness of Standard Local Anesthetic Bupivacaine and Liposomal Bupivacaine for Postoperative Pain Control in Patients Undergoing Truncal Incisions: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e210753. doi: 10.1001/jamanetworkopen.2021.0753.
- Individual participant dataSharing planned: No
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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.
Kristofer M Charlton-Ouw, MD FACS principal investigator
University of Texas Health Science Center, Department of Cardiothoracic and Vascular Surgery, UT Medical School at Houston
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 Exparel and Bupivacaine hydrochloride in people with Postoperative Pain, run by The University of Texas Health Science Center, Houston 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 4 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 16 Oct 2018. 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 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?
Yes. Results are posted in the registry (first posted 16 Oct 2018). 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 as Assessed by a Numeric Pain Scale (NPS) (time frame: postoperative day 1). The study lists 9 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 NCT02111746, which also lists 1 linked publication.
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 16 Oct 2018.