Pain, PostoperativePhase 4NCT05231460
Pain Management Study
A Phase 4 study testing Active Comparator: narcotic regimen with TAP block, Active Comparator: narcotic regimen with no TAP block and non-narcotic regimen with TAP block in people with Pain, Postoperative, run by University of Arizona at 1 site in United States.
Trial summary
This study aims to better understand the role that narcotic vs. non-narcotic multimodal pain management play in patients' pain following bariatric surgery (Laproscopic Surgery and Robotic Assisted Surgery). Participation in this study will last approximately 90 days following surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Active Comparator: narcotic regimen with TAP block, Active Comparator: narcotic regimen with no TAP block and non-narcotic regimen with TAP block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2022to Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Laparoscopic or Robotic Sleeve Gastrectomy bariatric surgery scheduled electively from the BUMCP Bariatric Clinic
- BMI>35kg/m2
- Patient of Principal Investigator or Co-Investigator
- 18 years or older
Who cannot join
- Chronic Pain Management on narcotics at New Patient visit or placed on narcotics prior to surgery
- Re-operative bariatric surgery procedures
- Admitted to the ICU after surgery
- Unable to walk 200ft
- Allergic to narcotics, steroids, or other medications used in the protocol
- Use of insulin to treat diabetes
Show all 11Show fewer
- Chronic Kidney Disease - stage 4 or greater
- Significant hepatic disease
- Carries a diagnosis of Pulmonary Hypertension
- Carries a diagnosis of Congestive Heart Failure
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
About this study
Official title: Do Experience of Pain and 30-Day Surgery Outcomes Differ in Robotic Bariatric Surgery Patients Treated With Narcotic vs. Non-narcotic Pain Management Protocols?
This study aims to better understand the role that narcotic vs. non-narcotic multimodal pain management play in patients' pain following bariatric surgery (Laproscopic Surgery and Robotic Assisted Surgery). Participation in this study will last approximately 90 days following surgery. During that 90 day period, participants will be asked to report pain and nausea every 4 hours to a study coordinator or nurse while they are recovering in the hospital. Following discharge from the hospital patients will be asked to report pain, nausea, and any medical changes 7 days, 30 days, and 90 days from surgical date.
The procedures and medications used in this study are FDA approved medical therapies and are part of Standard of Care for this population. This study aims to therapeutically investigate efficacy of the proposed pain management regimens. The procedures and individual medications are not the subject of research as they are considered routine well established and documented interventions for obesity and the treatment of post operative pain.
Read the detailed description
The majority of patients who undergo surgery will require treatment for the management of acute post-surgical pain. The use of narcotics after elective surgical procedures has contributed to the current opioid epidemic. Striking the right balance of treatment and use of narcotics vs. non-narcotic medications is at a crucial juncture in surgery.
Post-surgical pain influences a patient's perception of quality of care, physical recovery, and length of stay. The threat of poor postoperative pain control is a fear of many patients who will have a surgical procedure. The post- operative pain regimen is traditionally chosen by the operating surgeon rather than in a shared decision-making model where patients are educated about choice and participate in management. This is one of many factors influencing use of medications for post-operative pain. If a patient develops longer term, chronic postsurgical pain it may lead to disability and diminish quality of life, increase healthcare utilization, increase healthcare costs, and result in loss of productivity.
Morbid obesity is a global epidemic that increases the risk of developing related complications such as cardiac failure, type 2 diabetes, hypertension, hyperlipidemia, degenerative joint disease with the development of chronic pain and decreased mobility, and sleep apnea. In 2013 and 2014, 50% of the population had or had been affected by obesity, defined as a BMI ≥30mg/kg2. An established and effective treatment for weight loss is elective bariatric surgery.
Laparoscopic bariatric surgery (>90% of cases) is associated with less postoperative pain than open surgery, however, opioids are still used frequently for analgesia. Opioid analgesia comes with many side effects including nausea, constipation, risk of postoperative ileus, hypopnea, hypoxemia, delayed ambulation and mortality. This patient population is at increased risk for hypoventilation and narcotic related post-operative complications.
In the BUMCP department of bariatric surgery, we began employing a post-operative multimodal pain control protocol in November of 2017 and noticed improvement in pain control, declining levels of nausea and a decrease in the length of stay with our patient population. All medications and surgical interventions are considered approved standard of care in surgery. Previous studies have shown that employing a multimodal pain control protocol, even intraoperatively, influences postoperative pain control, nausea, emesis as well as chronic postoperative pain. In mid-2018 we began offering patients tap blocks which we believe have offered patients more consistent post- operative pain control.
Postsurgical pain control is imperative as it influences a patient's quality of care and life, recovery, and length of stay. Poor pain control can not only lead to increased healthcare utilization/costs, whereas use of opioid analgesia comes with side effects including nausea, constipation, risk of postoperative ileus, hypopnea, hypoxemia, delayed ambulation, mortality, and the increased possibility of long-term narcotic addiction. In the population that suffers from obesity it is desirable to reduce the narcotics being used as they are at increased risk for hypoventilation and post-operative complications. The BUMCP bariatric surgery department began employing a post-operative multimodal pain control protocol and noticed improvement in pain control, a decrease in perioperative morbidity from narcotic use and a decreased length of stay in the elective patient population undergoing primary bariatric surgery. This study will contribute to our knowledge of whether a non-narcotic, multi-modal post-operative pain management protocol is equivalent, if not superior in multiple facets compared to narcotic use.
Objectives
Study Hypothesis:
The use of a multi-modal, non-narcotic pain management regimen in postoperative bariatric patients will have equivalent, if not superior, postoperative outcomes compared with patient receiving narcotic pain management regimen. Those patients receiving a TAP block will have better pain control in the first 24 hours post-op.
Primary outcome measure:
Patient reported postoperative pain using the Wong Baker Faces pain scale (mean of all reported scores till the earlier of discharge and 24 hours postoperative).
Secondary outcomes measures:
- Postoperative nausea numerical rating scale (0-5)
- Length of time before subject can complete 200 feet of ambulation post-op
- Hospital length of stay
- Readmissions for pain control up to 30-day postoperatively (as binary Yes/No and also as a count variable)
- Conditions
- Pain, Postoperative
- Being tested
- Active Comparator: narcotic regimen with TAP block, Active Comparator: narcotic regimen with no TAP block, non-narcotic regimen with TAP block, non-narcotic regimen with no TAP block
- Keywords
- Transversus Abdominis Plane (TAP) Block, Bariatric Surgery, Pain, post-operative, Analgesics, Non-Narcotic, Analgesics, Narcotic, Sleeve gastrectomy, Gastric Sleeve, Postoperative Complications
- Medical subject headings
- Pain, Postoperative, Bites and Stings, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator: narcotic regimen with TAP blockDrug
Patient will receive Tap Block to 15ml of 0.5% Ropivacaine and will be administered the following Narcotic Pain Regimen post-operatively:
- PO Oxycodone 5mg, 10mg q4h for moderate and severe pain
- IV Dilaudid 1mg q3h for breakthrough pain
Active Comparator: narcotic regimen with no TAP blockDrug
Patient will not receive TAP block and will be administered the following Narcotic Pain Regimen post-operatively:
- PO Oxycodone 5mg, 10mg q4h for moderate and severe pain
- IV Dilaudid 1mg q3h for breakthrough pain
non-narcotic regimen with TAP blockDrug
Patient will receive Tap Block to 15ml of 0.5% Ropivacaine and will be administered the following Non-narcotic Pain Regimen post-operatively:
- Toradol 15mg q6h
- Tylenol 1000mg q8h
- Gabapentin 100mg three times a day
non-narcotic regimen with no TAP blockDrug
Patient will not receive TAP block and will be administered the following Non-narcotic Pain Regimen post-operatively:
- Toradol 15mg q6h
- Tylenol 1000mg q8h
- Gabapentin 100mg three times a day
| Study group | Role | What they receive |
|---|---|---|
| narcotic regimen with TAP block | Active comparator | Patient will receive Tap Block and will be administered the Narcotic Pain Regimen post-operatively Receives: Drug: Active Comparator: narcotic regimen with TAP block |
| narcotic regimen with no TAP block | Active comparator | Patient will not receive TAP block and will be administered the Narcotic Pain Regimen post-operatively Receives: Drug: Active Comparator: narcotic regimen with no TAP block |
| non-narcotic regimen with TAP block | Active comparator | Patient will receive Tap Block and will be administered Non-narcotic Pain Regimen post-operatively Receives: Drug: non-narcotic regimen with TAP block |
| non-narcotic regimen with no TAP block | Active comparator | Patient will not receive TAP block and will be administered Non-narcotic Pain Regimen post-operatively Receives: Drug: non-narcotic regimen with no TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Patient reported postoperative pain using the Wong Baker Faces pain scale. The scale shows a series of six faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable. Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Measured: discharge or 24 hours postoperative, whichever is first
Secondary outcomes (4)
Postoperative nausea
Postoperative nausea defined by numerical rating scale (0-5)
Measured: post-operative until patient discharge or up to 90 days, whichever comes first
200 foot ambulation
Length of time before subject can complete 200 feet of ambulation post-op
Measured: post-operative until patient discharge or up to 90 days, whichever comes first
Hospital length of stay
Patient's length of stay in the hospital
Measured: post-operative until patient discharge or up to 90 days, whichever comes first
Readmissions
Readmissions for pain control
Measured: up to 30-day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start18 Feb 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Factorial
- Model description
- Each subject will be randomized at 1:1 ratio to receive either the Narcotic Pain Regimen or the Non-narcotic Pain Regimen and will also be randomized at 1:1 ratio to receive either TAP block or no TAP block. Eligible subjects will therefore be randomized to one of four arms with approximately equal sizes:1) narcotic regimen with TAP block; 2) narcotic regimen with no TAP block; 3) non-narcotic regimen with TAP block; 4) non-narcotic regimen with no TAP block. The primary comparison will be between narcotic and non-narcotic regimens (arms 1 and 2 combined versus arms 3 and 4 combined). Comparison of TAP block versus no TAP block (arms 1 and 3 combined versus arms 2 and 4 combined) will performed as a secondary analysis.
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Lovato, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231460
- Sponsor's protocol ID
- 2108122253
- Status last verified
- Aug 2025
- First submitted
- 21 Dec 2021
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be retained for future use. Data will not be shared with collaborating entities nor sold/shared with pharmaceutical companies
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Experience of Pain and 30-Day Surgery Outcomes Differ in Robotic Bariatric Surgery Patients Treated With Narcotic vs. Non-narcotic Pain Management Protocols?
- ClinicalTrials.gov ID
- NCT05231460
- Acronym / sponsor ID
- 2108122253
- Conditions
- Pain, Postoperative
- Keywords
- Transversus Abdominis Plane (TAP) Block, Bariatric Surgery, Pain, post-operative, Analgesics, Non-Narcotic, Analgesics, Narcotic, Sleeve gastrectomy, Gastric Sleeve, Postoperative Complications
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Feb 2022 (actual)
- 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.
This study aims to better understand the role that narcotic vs. non-narcotic multimodal pain management play in patients' pain following bariatric surgery (Laproscopic Surgery and Robotic Assisted Surgery). Participation in this study will last approximately 90 days following surgery. During that 90 day period, participants will be asked to report pain and nausea every 4 hours to a study coordinator or nurse while they are recovering in the hospital. Following discharge from the hospital patients will be asked to report pain, nausea, and any medical changes 7 days, 30 days, and 90 days from surgical date.
The procedures and medications used in this study are FDA approved medical therapies and are part of Standard of Care for this population. This study aims to therapeutically investigate efficacy of the proposed pain management regimens. The procedures and individual medications are not the subject of research as they are considered routine well established and documented interventions for obesity and the treatment of post operative pain.
Detailed description
The majority of patients who undergo surgery will require treatment for the management of acute post-surgical pain. The use of narcotics after elective surgical procedures has contributed to the current opioid epidemic. Striking the right balance of treatment and use of narcotics vs. non-narcotic medications is at a crucial juncture in surgery.
Post-surgical pain influences a patient's perception of quality of care, physical recovery, and length of stay. The threat of poor postoperative pain control is a fear of many patients who will have a surgical procedure. The post- operative pain regimen is traditionally chosen by the operating surgeon rather than in a shared decision-making model where patients are educated about choice and participate in management. This is one of many factors influencing use of medications for post-operative pain. If a patient develops longer term, chronic postsurgical pain it may lead to disability and diminish quality of life, increase healthcare utilization, increase healthcare costs, and result in loss of productivity.
Morbid obesity is a global epidemic that increases the risk of developing related complications such as cardiac failure, type 2 diabetes, hypertension, hyperlipidemia, degenerative joint disease with the development of chronic pain and decreased mobility, and sleep apnea. In 2013 and 2014, 50% of the population had or had been affected by obesity, defined as a BMI ≥30mg/kg2. An established and effective treatment for weight loss is elective bariatric surgery.
Laparoscopic bariatric surgery (>90% of cases) is associated with less postoperative pain than open surgery, however, opioids are still used frequently for analgesia. Opioid analgesia comes with many side effects including nausea, constipation, risk of postoperative ileus, hypopnea, hypoxemia, delayed ambulation and mortality. This patient population is at increased risk for hypoventilation and narcotic related post-operative complications.
In the BUMCP department of bariatric surgery, we began employing a post-operative multimodal pain control protocol in November of 2017 and noticed improvement in pain control, declining levels of nausea and a decrease in the length of stay with our patient population. All medications and surgical interventions are considered approved standard of care in surgery. Previous studies have shown that employing a multimodal pain control protocol, even intraoperatively, influences postoperative pain control, nausea, emesis as well as chronic postoperative pain. In mid-2018 we began offering patients tap blocks which we believe have offered patients more consistent post- operative pain control.
Postsurgical pain control is imperative as it influences a patient's quality of care and life, recovery, and length of stay. Poor pain control can not only lead to increased healthcare utilization/costs, whereas use of opioid analgesia comes with side effects including nausea, constipation, risk of postoperative ileus, hypopnea, hypoxemia, delayed ambulation, mortality, and the increased possibility of long-term narcotic addiction. In the population that suffers from obesity it is desirable to reduce the narcotics being used as they are at increased risk for hypoventilation and post-operative complications. The BUMCP bariatric surgery department began employing a post-operative multimodal pain control protocol and noticed improvement in pain control, a decrease in perioperative morbidity from narcotic use and a decreased length of stay in the elective patient population undergoing primary bariatric surgery. This study will contribute to our knowledge of whether a non-narcotic, multi-modal post-operative pain management protocol is equivalent, if not superior in multiple facets compared to narcotic use.
Objectives
Study Hypothesis:
The use of a multi-modal, non-narcotic pain management regimen in postoperative bariatric patients will have equivalent, if not superior, postoperative outcomes compared with patient receiving narcotic pain management regimen. Those patients receiving a TAP block will have better pain control in the first 24 hours post-op.
Primary outcome measure:
Patient reported postoperative pain using the Wong Baker Faces pain scale (mean of all reported scores till the earlier of discharge and 24 hours postoperative).
Secondary outcomes measures:
- Postoperative nausea numerical rating scale (0-5)
- Length of time before subject can complete 200 feet of ambulation post-op
- Hospital length of stay
- Readmissions for pain control up to 30-day postoperatively (as binary Yes/No and also as a count variable)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Each subject will be randomized at 1:1 ratio to receive either the Narcotic Pain Regimen or the Non-narcotic Pain Regimen and will also be randomized at 1:1 ratio to receive either TAP block or no TAP block. Eligible subjects will therefore be randomized to one of four arms with approximately equal sizes:1) narcotic regimen with TAP block; 2) narcotic regimen with no TAP block; 3) non-narcotic regimen with TAP block; 4) non-narcotic regimen with no TAP block. The primary comparison will be between narcotic and non-narcotic regimens (arms 1 and 2 combined versus arms 3 and 4 combined). Comparison of TAP block versus no TAP block (arms 1 and 3 combined versus arms 2 and 4 combined) will performed as a secondary analysis.
| Arm | Type | Receives |
|---|---|---|
| narcotic regimen with TAP block | Active comparator | Drug: Active Comparator: narcotic regimen with TAP blockPatient will receive Tap Block and will be administered the Narcotic Pain Regimen post-operatively |
| narcotic regimen with no TAP block | Active comparator | Drug: Active Comparator: narcotic regimen with no TAP blockPatient will not receive TAP block and will be administered the Narcotic Pain Regimen post-operatively |
| non-narcotic regimen with TAP block | Active comparator | Drug: non-narcotic regimen with TAP blockPatient will receive Tap Block and will be administered Non-narcotic Pain Regimen post-operatively |
| non-narcotic regimen with no TAP block | Active comparator | Drug: non-narcotic regimen with no TAP blockPatient will not receive TAP block and will be administered Non-narcotic Pain Regimen post-operatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Laparoscopic or Robotic Sleeve Gastrectomy bariatric surgery scheduled electively from the BUMCP Bariatric Clinic
- BMI>35kg/m2
- Patient of Principal Investigator or Co-Investigator
- 18 years or older
Key exclusion criteria (11 listed)
- Chronic Pain Management on narcotics at New Patient visit or placed on narcotics prior to surgery
- Re-operative bariatric surgery procedures
- Admitted to the ICU after surgery
- Unable to walk 200ft
- Allergic to narcotics, steroids, or other medications used in the protocol
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 |
|---|---|---|
| Active Comparator: narcotic regimen with TAP blockPatient will receive Tap Block to 15ml of 0.5% Ropivacaine and will be administered the following Narcotic Pain Regimen post-operatively: * PO Oxycodone 5mg, 10mg q4h for moderate and severe pain * IV Dilaudid 1mg q3h for breakthrough pain | Drug | narcotic regimen with TAP block |
| Active Comparator: narcotic regimen with no TAP blockPatient will not receive TAP block and will be administered the following Narcotic Pain Regimen post-operatively: * PO Oxycodone 5mg, 10mg q4h for moderate and severe pain * IV Dilaudid 1mg q3h for breakthrough pain | Drug | narcotic regimen with no TAP block |
| non-narcotic regimen with TAP blockPatient will receive Tap Block to 15ml of 0.5% Ropivacaine and will be administered the following Non-narcotic Pain Regimen post-operatively: * Toradol 15mg q6h * Tylenol 1000mg q8h * Gabapentin 100mg three times a day | Drug | non-narcotic regimen with TAP block |
| non-narcotic regimen with no TAP blockPatient will not receive TAP block and will be administered the following Non-narcotic Pain Regimen post-operatively: * Toradol 15mg q6h * Tylenol 1000mg q8h * Gabapentin 100mg three times a day | Drug | non-narcotic regimen with no TAP block |
Primary outcome
postoperative pain
Time frame: discharge or 24 hours postoperative, whichever is first
Patient reported postoperative pain using the Wong Baker Faces pain scale. The scale shows a series of six faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable. Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
4 secondary outcomes
Postoperative nausea
Time frame: post-operative until patient discharge or up to 90 days, whichever comes first
200 foot ambulation
Time frame: post-operative until patient discharge or up to 90 days, whichever comes first
Hospital length of stay
Time frame: post-operative until patient discharge or up to 90 days, whichever comes first
Readmissions
Time frame: up to 30-day postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No. Data will not be retained for future use. Data will not be shared with collaborating entities nor sold/shared with pharmaceutical companies
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Active Comparator: narcotic regimen with TAP block, Active Comparator: narcotic regimen with no TAP block and non-narcotic regimen with TAP block in people with Pain, Postoperative, run by University of Arizona 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 4 inclusion and 11 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: enrolling by invitation, as of the sponsor's last update on 24 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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: discharge or 24 hours postoperative, whichever is first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2025.