Lumbar OsteoarthritisNCT02700451
Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes
A study testing Ketorolac and Acetaminophen in people with Lumbar Osteoarthritis and Spondylosis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively. The widespread use of opioids, however, is associated with a number of side effects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Osteoarthritis, Spondylosis, Lumbar Disc Disease
- What is being tested?
- Ketorolac and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Mar 2023
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75
- Require 1 or 2 level lumbar spinal fusion through posterior or lateral approach
- No history of long term opioid use (daily or almost daily opioid use > 2 weeks) and not on opiates at time of presentation to clinic
Who cannot join
- Documented allergy to NSAIDs or Acetaminophen
- History of: Peptic Ulcer Disease, Congestive heart failure, Chronic liver disease, Elevated alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) greater than 1.5 times control, Bleeding disorder, Renal dysfunction (Serum creatinine > 1.5 mg/dL), Glucocorticoid use within 1 month of surgery
- Current smokers (quite date < 30 days ago)
- Revision for pseudarthrosis
- Patients who are unable to physically or mentally provide consent to the study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: A Randomized Controlled Trial of Post-operative Acetaminophen Versus Nonsteroidal Anti-Inflammatory Drug (NSAID) Use on Lumbar Spinal Fusion Outcomes
Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively. The widespread use of opioids, however, is associated with a number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation, dizziness and itching amongst others. Some investigators have suggested that anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as a result, lower opioid-related side effects.
The purpose of this study is to test this hypothesis and determine if postoperative anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid required to control pain following surgery. A secondary goal of this study is to examine if the change in pain medication will lead to decreased overall pain levels, decreased opioid-related side effects and improved function [quicker ambulation with physical therapy (PT), earlier return to work, etc.].
Read the detailed description
Given the potential for non-steroidal anti inflammatory drugs (NSAIDs) and acetaminophen to decrease opioid requirements following spine surgery, the investigators propose a prospective, randomized, double-blinded clinical trial comparing the efficacy of intravenous (IV) acetaminophen (Group A) or IV ketorolac (Group K) versus placebo (Group P). The impact of treatment on perioperative opioid use, opioid-related complications, functional outcomes and rates of pseudarthrosis following 1 or 2 level lumbar fusion surgery will be measured in each group. The specific aims of this study are as follows:
- Specific Aim 1: Determine the impact of IV ketorolac or IV acetaminophen use on immediate postoperative opioid requirements, postoperative pain levels and opiate related symptoms using the Opiate-Related Symptom Distress Scale (ORSDS)
- Specific Aim 2: Determine the impact of IV ketorolac or IV acetaminophen use on functional outcomes defined by return to work, Oswestry Disability Index (ODI) and the Veterans Rand-12 (VR-12) Health Survey
The primary outcome is to determine the total postoperative opioid dose (in oral morphine equivalents) in each group. The investigators hypothesize that patients in Group A and Group K will have lower total opioid use, suffer from fewer opiate related symptoms and have similar rates of pseudarthrosis to patients in Group P. The investigators hypothesize that patients in Group A and Group K will have a quicker return to work and improved early functional outcomes although they acknowledge that long term functional outcomes may be the same for all groups.
- Being tested
- Ketorolac, Acetaminophen, Placebo
- Keywords
- IV acetaminophen, IV Ketorolac, Post-operative analgesia, Opioid use
- Medical subject headings
- Osteoarthritis, Spine, Spondylosis, Intervertebral disc disease, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Toradol
Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
AcetaminophenDrug
Also called Tylenol, Ofirmev
Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
PlaceboDrug
Also called Normal Saline
Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous (IV) Placebo | Placebo comparator | IV Placebo arm Receives: Drug: Placebo |
| IV Ketorolac | Experimental | IV Ketorolac arm Receives: Drug: Ketorolac |
| IV Acetaminophen | Experimental | IV Acetaminophen arm Receives: Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Opioid Use
Measure the impact of treatment on total opioid use during the hospital stay
Measured: Hospital stay (2-4 days)
Secondary outcomes (24)
Opioid Use at 4-6 Weeks
Track opioid use after discharge for the first 4-6 weeks
Measured: 4-6 weeks
Opioid Use at 3 Months
Track opioid use after discharge for the first 3 months; assess for continued opioid use
Measured: 3 months
Opioid Use at 1 Year
Track opioid use after discharge for the first 1 year; assess for continued opioid use
Measured: 1 year
Opioid Use at 2 Years
Track total opioid use after discharge for the first 2 years; assess for continued opioid use
Measured: 2 years
Numerical Pain Rating Scale
Validated pain scale; will be completed by patient Minimum Score: 0 \& Maximum score 100 A lower score is representative of a low pain level
Measured: 1 days and 3 days
Brief Pain Inventory
The Brief Pain Inventory (BPI) is a self-administered questionnaire for chronic pain conditions. The BPI gives two main scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score corresponds to the item on pain interference. The seven sub-items are rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70. The first item, pain drawing diagrams (painful and most painful areas) and the items on pain relief treatment or medication (list of the treatments and amount of relief) do not contribute to the scoring.
Measured: 1 day and 3 days
Opioid Related Side Effects
Ileus, nausea/vomiting, first bowel movement, first flatus, treated pruritis will be identified and recorded
Measured: Hospital Stay (1-4 days)
Perioperative Complications - Drain Output
Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded
Measured: Hospital Stay (1-4 days)
Perioperative Complications - Transfusion Rate
Complications such as: excessive drain output, elevation in creatinine, and the need for transfusions will be identified and recorded
Measured: Hospital Stay (1-4 days)
Days to Walk 50 ft With PT
Days needed to be able to walk 50ft with PT
Measured: Hospital Stay (1-4 days)
Length of Stay
Will record date of discharge
Measured: Hospital Stay (1-4 days)
Veterans Rand - 12
The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome.
This score range apply to both PCS and MCS.
Measured: pre-operative
Oswestry Disability Index
The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.
Measured: pre-operative
Veterans Rand - 12
The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome.
This score range apply to both PCS and MCS.
Measured: 3 month follow up
Oswestry Disability Index
The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.
Measured: 3 month follow up
Return to Work
Record return to work
Measured: 3 month follow up
Veterans Rand - 12
The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome.
This score range apply to both PCS and MCS.
Measured: 1 year follow up
Oswestry Disability Index
The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.
Measured: 1 year follow up
Return to Work
Record return to work
Measured: 1 year follow up
Numerical Pain Rating Scale
Validated pain scale; will be completed by patient Minimum Score: 0 \& Maximum score 100 A lower score is representative of a low pain level
Measured: 1 year follow up
Veterans Rand - 12
The Veterans RAND 12 Item Health Survey (VR-12) is a brief, generic, multi-use, self-administered health survey comprised of 12 items. The instrument is primarily used to measure health related quality of life, to estimate disease burden and to evaluate disease-specific benchmarks with other populations. The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health.. The 12 items are summarized into two scores, a "Physical Health Summary Measure {PCS-physical component score}" and a "Mental Health Summary Measure {MCS-mental component score}". Score range is 0 to 100, higher score denotes a better outcome.
This score range apply to both PCS and MCS.
Measured: 2 year follow up
Oswestry Disability Index
The Oswestry Disability Index (ODI) is the most commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. Thus, for every question not answered, the denominator is reduced by 5. If a patient marks more than one statement in a question, the highest scoring statement is recorded as a true indication of disability.
Measured: 2 year follow up
Return to Work
Record return to work
Measured: 2 year follow up
Numerical Pain Rating Scale
Validated pain scale; will be completed by patient Minimum Score: 0 \& Maximum score 100 A lower score is representative of a low pain level
Measured: 2 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startMar 2016
- Primary completion31 Dec 2021
- Study completionMar 2023
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.
- Other trials for Lumbar OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Himo Gang, Study director, Research Manager for Spine ResearchHarvinder Sandhu, MD, Principal investigator, Associate Professor of Orthopedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700451
- Sponsor's protocol ID
- 2014-333
- Status last verified
- Jun 2023
- First submitted
- 18 Feb 2016
- Last updated
- 10 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Post-operative Acetaminophen Versus Nonsteroidal Anti-Inflammatory Drug (NSAID) Use on Lumbar Spinal Fusion Outcomes
- ClinicalTrials.gov ID
- NCT02700451
- Acronym / sponsor ID
- 2014-333
- Keywords
- IV acetaminophen, IV Ketorolac, Post-operative analgesia, Opioid use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Posted 10 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively. The widespread use of opioids, however, is associated with a number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation, dizziness and itching amongst others. Some investigators have suggested that anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as a result, lower opioid-related side effects.
The purpose of this study is to test this hypothesis and determine if postoperative anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid required to control pain following surgery. A secondary goal of this study is to examine if the change in pain medication will lead to decreased overall pain levels, decreased opioid-related side effects and improved function [quicker ambulation with physical therapy (PT), earlier return to work, etc.].
Detailed description
Given the potential for non-steroidal anti inflammatory drugs (NSAIDs) and acetaminophen to decrease opioid requirements following spine surgery, the investigators propose a prospective, randomized, double-blinded clinical trial comparing the efficacy of intravenous (IV) acetaminophen (Group A) or IV ketorolac (Group K) versus placebo (Group P). The impact of treatment on perioperative opioid use, opioid-related complications, functional outcomes and rates of pseudarthrosis following 1 or 2 level lumbar fusion surgery will be measured in each group. The specific aims of this study are as follows:
- Specific Aim 1: Determine the impact of IV ketorolac or IV acetaminophen use on immediate postoperative opioid requirements, postoperative pain levels and opiate related symptoms using the Opiate-Related Symptom Distress Scale (ORSDS)
- Specific Aim 2: Determine the impact of IV ketorolac or IV acetaminophen use on functional outcomes defined by return to work, Oswestry Disability Index (ODI) and the Veterans Rand-12 (VR-12) Health Survey
The primary outcome is to determine the total postoperative opioid dose (in oral morphine equivalents) in each group. The investigators hypothesize that patients in Group A and Group K will have lower total opioid use, suffer from fewer opiate related symptoms and have similar rates of pseudarthrosis to patients in Group P. The investigators hypothesize that patients in Group A and Group K will have a quicker return to work and improved early functional outcomes although they acknowledge that long term functional outcomes may be the same for all groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous (IV) Placebo | Placebo comparator | Drug: PlaceboIV Placebo arm |
| IV Ketorolac | Experimental | Drug: KetorolacIV Ketorolac arm |
| IV Acetaminophen | Experimental | Drug: AcetaminophenIV Acetaminophen arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75
- Require 1 or 2 level lumbar spinal fusion through posterior or lateral approach
- No history of long term opioid use (daily or almost daily opioid use > 2 weeks) and not on opiates at time of presentation to clinic
Key exclusion criteria (5 listed)
- Documented allergy to NSAIDs or Acetaminophen
- History of: Peptic Ulcer Disease, Congestive heart failure, Chronic liver disease, Elevated alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) greater than 1.5 times control, Bleeding disorder, Renal dysfunction (Serum creatinine > 1.5 mg/dL), Glucocorticoid use within 1 month of surgery
- Current smokers (quite date < 30 days ago)
- Revision for pseudarthrosis
- Patients who are unable to physically or mentally provide consent to the study procedures.
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 |
|---|---|---|
| KetorolacAlso: ToradolAge 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. | Drug | IV Ketorolac |
| AcetaminophenAlso: Tylenol, OfirmevIntravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. | Drug | IV Acetaminophen |
| PlaceboAlso: Normal SalineIntravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. | Drug | Intravenous (IV) Placebo |
Primary outcome
Perioperative Opioid Use
Time frame: Hospital stay (2-4 days)
Measure the impact of treatment on total opioid use during the hospital stay
24 secondary outcomes
Opioid Use at 4-6 Weeks
Time frame: 4-6 weeks
Opioid Use at 3 Months
Time frame: 3 months
Opioid Use at 1 Year
Time frame: 1 year
Opioid Use at 2 Years
Time frame: 2 years
Numerical Pain Rating Scale
Time frame: 1 days and 3 days
Brief Pain Inventory
Time frame: 1 day and 3 days
Opioid Related Side Effects
Time frame: Hospital Stay (1-4 days)
Perioperative Complications - Drain Output
Time frame: Hospital Stay (1-4 days)
Perioperative Complications - Transfusion Rate
Time frame: Hospital Stay (1-4 days)
Days to Walk 50 ft With PT
Time frame: Hospital Stay (1-4 days)
Length of Stay
Time frame: Hospital Stay (1-4 days)
Veterans Rand - 12
Time frame: pre-operative
Oswestry Disability Index
Time frame: pre-operative
Veterans Rand - 12
Time frame: 3 month follow up
Oswestry Disability Index
Time frame: 3 month follow up
Return to Work
Time frame: 3 month follow up
Veterans Rand - 12
Time frame: 1 year follow up
Oswestry Disability Index
Time frame: 1 year follow up
Return to Work
Time frame: 1 year follow up
Numerical Pain Rating Scale
Time frame: 1 year follow up
Veterans Rand - 12
Time frame: 2 year follow up
Oswestry Disability Index
Time frame: 2 year follow up
Return to Work
Time frame: 2 year follow up
Numerical Pain Rating Scale
Time frame: 2 year follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Catherine Himo Gang study director
Research Manager for Spine Research
Harvinder Sandhu, MD principal investigator
Associate Professor of Orthopedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketorolac and Acetaminophen in people with Lumbar Osteoarthritis and Spondylosis, run by Hospital for Special Surgery, New York 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 5 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 10 Jul 2023. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 10 Jul 2023). 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?
Perioperative Opioid Use (time frame: Hospital stay (2-4 days)). 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 10 Jul 2023.