Postoperative PainPhase 4NCT02424591
A Comparison of Intra-op Ketamine vs Placebo in Patients Having Spinal Fusion
A Phase 4 study testing Ketamine in people with Postoperative Pain, run by NYU Langone Health at 1 site in United States.
Trial summary
Postoperative pain is severe after major spine surgery. Opioids such as morphine and hydromorphone are routinely used for postoperative pain control. These drugs have significant side effects, most importantly respiratory depression, nausea, constipation and tolerance. 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?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Oct 2016
- 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
- Adult (>/=18)
- male or female
- Undergoing surgery for multilevel (>2 level) spinal fusion from a posterior approach.
- General anesthesia
- English speakers such that they can complete the pain score and satisfaction questionnaires whose scores are a critical outcome variable.
- If female, subject is non-lactating and is either: a. Post-menopausal or post hysterectomy; b. Of childbearing potential but is not pregnant at time of baseline as determined by pre-surgical pregnancy testing.
- Subject is American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
Who cannot join
- Cognitively impaired (by history)
- Subject with a history of psychosis
- Subject known to have significant hepatic disease
- Subject for whom opioids or ketamine are contraindicated
- Patients with narrow angle glaucoma
- Increased intracranial or intraocular pressure
- If female, is either pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Single Blinded Comparison of Intraoperative Ketamine Infusion Versus Placebo in Patients Having Spinal Fusion
Postoperative pain is severe after major spine surgery. Opioids such as morphine and hydromorphone are routinely used for postoperative pain control. These drugs have significant side effects, most importantly respiratory depression, nausea, constipation and tolerance. Moreover, many spine surgery patients have used opioid pain medication for back pain long term, leading to pre-surgical opioid tolerance and increased postoperative pain. This has led to a search for adjuvant medications to reduce the use of opioids and reduce opioid mediated side effects and tolerance.
Ketamine is an intravenous anesthetic with analgesic properties in subanesthetic doses. Ketamine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. NMDA receptors are involved in central pain sensitization via wind-up phenomenon and altered pain memory, a process which can be blocked by ketamine. NMDA receptor antagonists may prevent the development of tolerance to opioids and hyperalgesia. Ketamine has been safely used to decrease pain in numerous studies. Ketamine can also act as an antidepressant with hours of administration.
Ketamine has rapid brain uptake and subsequent re-distribution with a distribution half-life of 10-15 minutes and an elimination half-life of 2 hours. Ketamine does not cause respiratory depression.
Read the detailed description
This is a prospective, single-blinded, placebo controlled single center trial. One hundred subjects (50 in each arm) will be enrolled. Subjects undergoing multilevel spinal fusion will be screened and have the study introduced and discussed with them during the preadmission visit. Subjects may also contact study personnel or be contacted by study personnel before admission. Upon admission on the day of surgery, patients will be re-screened, recruited, have informed consent obtained. After consent is achieved in the pre-admission clinic prior to surgery, patients will be asked to fill out Beck's depression inventory (BDI), post-operative quality of recovery score(QoR-15) form, visual analog scale (VAS) for pain and short form McGill pain questionnaire to establish baseline scores. These forms can be completed at pre-admission testing, at home or on the day of surgery. The three forms will be on postoperative days (POD) 1, 2 and 3; only the VAS will be given in the Post-Anesthesia Care Unit (PACU). Eligible subjects will be assigned to either the ketamine or placebo group based on a computer generated randomization (randomization.com). Baseline demographic data as well as medical history and medication list will be recorded.
Anesthetic management for this study will be exactly the same management that we are currently providing for patients undergoing multilevel spinal fusions. The only difference in care between the placebo group and the treatment group will be the addition of a low dose ketamine infusion in the treatment group. The placebo group will receive a fentanyl infusion at 1 mcg/kg/hr during the surgery and a morphine PCA for postoperative pain control. The placebo group will receive additional fentanyl as needed on the operating room and additional morphine as needed in the recovery room.
Anesthetic management for both groups will start with IV placement and routine (American Society of Anesthesiologists - ASA ) monitors. An arterial catheter may be placed at the discretion of the attending anesthesiologist. After preoxygenation, general anesthesia will be induced with Propofol 1 to 2 mg/kg, fentanyl 1 to 2 mcg/kg, and rocuronium .6 mg/kg. Maintenance of anesthesia will be a propofol infusion starting at 150 mcg/kg/min, fentanyl 1 mcg/kg/hr. Additionally, the ketamine group will receive a ketamine infusion at a rate of 10 mcg/kg/min starting after intubation and terminated at the start of skin closure. All patients will be treated with zofran and ofirmev during surgical closing. Pre-induction midazolam will be administered at the discretion of the anesthesiologist. No NSAIDS will be given because of bleeding risk. Sevoflurane may be used for brief periods at the beginning and end of the procedure to cover times when total intravenous anesthesia (TIVA) is not practical, i.e. when moving or positioning the patient. Additional fentanyl and rocuronium boluses can be given as needed. Administration of corticosteroids per surgeon's request will be recorded. Anesthetics will be titrated to maintain a Bispectral (BIS) index of 40 to 60. Patients will be awakened, extubated and transferred to the PACU after following simple commands. Morphine patient controlled anesthesia (PCA) at a setting of 1 mg dose with a 6 minutes lockout will be started immediately on arrival in PACU. While in the PACU, all subjects who do not have adequate pain control will receive rescue dose of morphine 2 mg. to 4 mg. as indicated by a numeric pain Rating Scale score > 3 or upon subjects' request. All narcotics and other pain medication given will be recorded. Postoperative nausea will be treated with droperidol .625 mg IV. If the patient's pain cannot be controlled with PCA morphine then a pain consult will be obtained. The pain service will be free to administer any medication deemed necessary to control the patient's pain.
PACU Monitoring: Once in the PACU, all patients will be monitored by PACU nurses per nursing protocol. The following questionnaires: 1) VAS for pain will be administered in the PACU. On postoperative day 1, 2 and 3 the McGill short form, VAS, Beck Depression Inventory (BDI) and QoR15 will be given.
The subjects who enroll in this study will be asked to fill out questionnaires at five different times. The questionnaires include The Beck depression inventory, McGill's short form pain questionnaire, Quality of Recovery - 15 form (QoR15) and the visual analog scale (VAS) for pain. The forms will be filled out at five separate times; preoperatively in pre-surgical testing or in the pre-surgical holding area of Tisch hospital, in the post anesthesia care unit of Tisch hospital after the surgery, on postoperative day #1, on postoperative day #2 and on postoperative day #3. In the PACU on the day of surgery, only the VAS will be given.
All subjects will be carefully monitored for safety and efficacy. While the ketamine or placebo is administered in the operating room, an anesthesiologist, Certified Registered Nurse Anesthetist (CRNA) or anesthesia resident will be present. In the PACU patients will have 1:1 or 1:2 nursing care. An anesthesiologist is immediately available in the PACU should a problem arise.
- Conditions
- Postoperative Pain
- Being tested
- Ketamine, Placebo
- Keywords
- Anesthesia Recovery Period, Spinal Fusion
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketalar
Infusion at a rate of 10 mcg/kg/min
PlaceboOther
Placebo IV
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Active comparator | ketamine group will be infused after intubation and terminated at the start of skin closure Receives: Drug: Ketamine |
| Placebo | Placebo comparator | placebo group will have standard of care rather than ketamine infusion Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on Questionnaires
Quality of Recovery 15 questions questionnaires that ask, on a scale of 0-10, with 0 always being bad and 10 always being best, how the patient is recovering. The total number is reviewed, so the highest total score possible is 150 and the lowest is 0.
Measured: Post-op Day 3
Secondary outcomes (2)
Pain Score
McGill Short Form measures pain in different ways. The first part of the form lists 15 adjectives for pain, for which the answers can be none (0), Mild (1), Moderate (2) and Severe (3). Descriptors 1-11 represent the sensory dimension of pain experience and 12-15 represent the affective dimension. A score of 0 is good, and a score of 45 indicates extreme pain. The lower the score the less pain a subject feels (better), as the scores go up, so do the pain levels (worse).
PPI (Present Pain Intensity) asks patients to measure pain from 0 (no pain) to 5 (excruciating). Again, a lower score is ideal.
Measured: Post-op Day 3
Beck's Depression Inventory
Beck's Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures attitudes and symptoms of depression. Each sentence has a rating from 0 to 3 and the sentences go from mild to fairly severe descriptions of moods. The numbers are tabulated, the lowest possible score is 0 and the highest is 63.
A score of 1-10 indicates normal ups and downs. 11-16 indicates a mild mood disturbance; 17-20, borderline clinical depression; 21-30, moderate depression; 31-40, severe depression; over 40, extreme depression
Measured: Post-op Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startAug 2014
- Primary completionJan 2016
- Study completionOct 2016
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 (6)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 NYU Langone HealthThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Ard, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424591
- Sponsor's protocol ID
- 14-00599
- Status last verified
- May 2017
- First submitted
- 2 Apr 2015
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Woolf CJ, Thompson SWN. The induction and maintenance of central sensitization is dependent on N-methyl-D-aspartic acid receptor activation; implications for the treatment of post-injury pain hypersensitivity states. Pain. 1991 Mar;44(3):293-299. doi: 10.1016/0304-3959(91)90100-C.
PubMed 1828878Mao J, Price DD, Mayer DJ. Mechanisms of hyperalgesia and morphine tolerance: a current view of their possible interactions. Pain. 1995 Sep;62(3):259-274. doi: 10.1016/0304-3959(95)00073-2.
PubMed 8657426Bell RF, Dahl JB, Moore RA, Kalso E. Perioperative ketamine for acute postoperative pain. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD004603. doi: 10.1002/14651858.CD004603.pub2.
PubMed 16437490Machado-Vieira R, Salvadore G, Diazgranados N, Zarate CA Jr. Ketamine and the next generation of antidepressants with a rapid onset of action. Pharmacol Ther. 2009 Aug;123(2):143-50. doi: 10.1016/j.pharmthera.2009.02.010. Epub 2009 May 3.
PubMed 19397926Yamauchi M, Asano M, Watanabe M, Iwasaki S, Furuse S, Namiki A. Continuous low-dose ketamine improves the analgesic effects of fentanyl patient-controlled analgesia after cervical spine surgery. Anesth Analg. 2008 Sep;107(3):1041-4. doi: 10.1213/ane.0b013e31817f1e4a.
PubMed 18713926Loftus RW, Yeager MP, Clark JA, Brown JR, Abdu WA, Sengupta DK, Beach ML. Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery. Anesthesiology. 2010 Sep;113(3):639-46. doi: 10.1097/ALN.0b013e3181e90914.
PubMed 20693876
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single Blinded Comparison of Intraoperative Ketamine Infusion Versus Placebo in Patients Having Spinal Fusion
- ClinicalTrials.gov ID
- NCT02424591
- Acronym / sponsor ID
- 14-00599
- Conditions
- Postoperative Pain
- Keywords
- Anesthesia Recovery Period, Spinal Fusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Apr 2015 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pain is severe after major spine surgery. Opioids such as morphine and hydromorphone are routinely used for postoperative pain control. These drugs have significant side effects, most importantly respiratory depression, nausea, constipation and tolerance. Moreover, many spine surgery patients have used opioid pain medication for back pain long term, leading to pre-surgical opioid tolerance and increased postoperative pain. This has led to a search for adjuvant medications to reduce the use of opioids and reduce opioid mediated side effects and tolerance.
Ketamine is an intravenous anesthetic with analgesic properties in subanesthetic doses. Ketamine is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) receptors. NMDA receptors are involved in central pain sensitization via wind-up phenomenon and altered pain memory, a process which can be blocked by ketamine. NMDA receptor antagonists may prevent the development of tolerance to opioids and hyperalgesia. Ketamine has been safely used to decrease pain in numerous studies. Ketamine can also act as an antidepressant with hours of administration.
Ketamine has rapid brain uptake and subsequent re-distribution with a distribution half-life of 10-15 minutes and an elimination half-life of 2 hours. Ketamine does not cause respiratory depression.
Detailed description
This is a prospective, single-blinded, placebo controlled single center trial. One hundred subjects (50 in each arm) will be enrolled. Subjects undergoing multilevel spinal fusion will be screened and have the study introduced and discussed with them during the preadmission visit. Subjects may also contact study personnel or be contacted by study personnel before admission. Upon admission on the day of surgery, patients will be re-screened, recruited, have informed consent obtained. After consent is achieved in the pre-admission clinic prior to surgery, patients will be asked to fill out Beck's depression inventory (BDI), post-operative quality of recovery score(QoR-15) form, visual analog scale (VAS) for pain and short form McGill pain questionnaire to establish baseline scores. These forms can be completed at pre-admission testing, at home or on the day of surgery. The three forms will be on postoperative days (POD) 1, 2 and 3; only the VAS will be given in the Post-Anesthesia Care Unit (PACU). Eligible subjects will be assigned to either the ketamine or placebo group based on a computer generated randomization (randomization.com). Baseline demographic data as well as medical history and medication list will be recorded.
Anesthetic management for this study will be exactly the same management that we are currently providing for patients undergoing multilevel spinal fusions. The only difference in care between the placebo group and the treatment group will be the addition of a low dose ketamine infusion in the treatment group. The placebo group will receive a fentanyl infusion at 1 mcg/kg/hr during the surgery and a morphine PCA for postoperative pain control. The placebo group will receive additional fentanyl as needed on the operating room and additional morphine as needed in the recovery room.
Anesthetic management for both groups will start with IV placement and routine (American Society of Anesthesiologists - ASA ) monitors. An arterial catheter may be placed at the discretion of the attending anesthesiologist. After preoxygenation, general anesthesia will be induced with Propofol 1 to 2 mg/kg, fentanyl 1 to 2 mcg/kg, and rocuronium .6 mg/kg. Maintenance of anesthesia will be a propofol infusion starting at 150 mcg/kg/min, fentanyl 1 mcg/kg/hr. Additionally, the ketamine group will receive a ketamine infusion at a rate of 10 mcg/kg/min starting after intubation and terminated at the start of skin closure. All patients will be treated with zofran and ofirmev during surgical closing. Pre-induction midazolam will be administered at the discretion of the anesthesiologist. No NSAIDS will be given because of bleeding risk. Sevoflurane may be used for brief periods at the beginning and end of the procedure to cover times when total intravenous anesthesia (TIVA) is not practical, i.e. when moving or positioning the patient. Additional fentanyl and rocuronium boluses can be given as needed. Administration of corticosteroids per surgeon's request will be recorded. Anesthetics will be titrated to maintain a Bispectral (BIS) index of 40 to 60. Patients will be awakened, extubated and transferred to the PACU after following simple commands. Morphine patient controlled anesthesia (PCA) at a setting of 1 mg dose with a 6 minutes lockout will be started immediately on arrival in PACU. While in the PACU, all subjects who do not have adequate pain control will receive rescue dose of morphine 2 mg. to 4 mg. as indicated by a numeric pain Rating Scale score > 3 or upon subjects' request. All narcotics and other pain medication given will be recorded. Postoperative nausea will be treated with droperidol .625 mg IV. If the patient's pain cannot be controlled with PCA morphine then a pain consult will be obtained. The pain service will be free to administer any medication deemed necessary to control the patient's pain.
PACU Monitoring: Once in the PACU, all patients will be monitored by PACU nurses per nursing protocol. The following questionnaires: 1) VAS for pain will be administered in the PACU. On postoperative day 1, 2 and 3 the McGill short form, VAS, Beck Depression Inventory (BDI) and QoR15 will be given.
The subjects who enroll in this study will be asked to fill out questionnaires at five different times. The questionnaires include The Beck depression inventory, McGill's short form pain questionnaire, Quality of Recovery - 15 form (QoR15) and the visual analog scale (VAS) for pain. The forms will be filled out at five separate times; preoperatively in pre-surgical testing or in the pre-surgical holding area of Tisch hospital, in the post anesthesia care unit of Tisch hospital after the surgery, on postoperative day #1, on postoperative day #2 and on postoperative day #3. In the PACU on the day of surgery, only the VAS will be given.
All subjects will be carefully monitored for safety and efficacy. While the ketamine or placebo is administered in the operating room, an anesthesiologist, Certified Registered Nurse Anesthetist (CRNA) or anesthesia resident will be present. In the PACU patients will have 1:1 or 1:2 nursing care. An anesthesiologist is immediately available in the PACU should a problem arise.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Active comparator | Drug: Ketamineketamine group will be infused after intubation and terminated at the start of skin closure |
| Placebo | Placebo comparator | Other: Placeboplacebo group will have standard of care rather than ketamine infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult (>/=18)
- male or female
- Undergoing surgery for multilevel (>2 level) spinal fusion from a posterior approach.
- General anesthesia
- English speakers such that they can complete the pain score and satisfaction questionnaires whose scores are a critical outcome variable.
Key exclusion criteria (7 listed)
- Cognitively impaired (by history)
- Subject with a history of psychosis
- Subject known to have significant hepatic disease
- Subject for whom opioids or ketamine are contraindicated
- Patients with narrow angle glaucoma
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 |
|---|---|---|
| KetamineAlso: KetalarInfusion at a rate of 10 mcg/kg/min | Drug | Ketamine |
| PlaceboPlacebo IV | Other | Placebo |
Primary outcome
Scores on Questionnaires
Time frame: Post-op Day 3
Quality of Recovery 15 questions questionnaires that ask, on a scale of 0-10, with 0 always being bad and 10 always being best, how the patient is recovering. The total number is reviewed, so the highest total score possible is 150 and the lowest is 0.
2 secondary outcomes
Pain Score
Time frame: Post-op Day 3
Beck's Depression Inventory
Time frame: Post-op Day 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1828878Woolf CJ, Thompson SWN. The induction and maintenance of central sensitization is dependent on N-methyl-D-aspartic acid receptor activation; implications for the treatment of post-injury pain hypersensitivity states. Pain. 1991 Mar;44(3):293-299. doi: 10.1016/0304-3959(91)90100-C.
- Background: PubMed 8657426Mao J, Price DD, Mayer DJ. Mechanisms of hyperalgesia and morphine tolerance: a current view of their possible interactions. Pain. 1995 Sep;62(3):259-274. doi: 10.1016/0304-3959(95)00073-2.
- Background: PubMed 16437490Bell RF, Dahl JB, Moore RA, Kalso E. Perioperative ketamine for acute postoperative pain. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD004603. doi: 10.1002/14651858.CD004603.pub2.
- Background: PubMed 19397926Machado-Vieira R, Salvadore G, Diazgranados N, Zarate CA Jr. Ketamine and the next generation of antidepressants with a rapid onset of action. Pharmacol Ther. 2009 Aug;123(2):143-50. doi: 10.1016/j.pharmthera.2009.02.010. Epub 2009 May 3.
- Background: PubMed 18713926Yamauchi M, Asano M, Watanabe M, Iwasaki S, Furuse S, Namiki A. Continuous low-dose ketamine improves the analgesic effects of fentanyl patient-controlled analgesia after cervical spine surgery. Anesth Analg. 2008 Sep;107(3):1041-4. doi: 10.1213/ane.0b013e31817f1e4a.
- Background: PubMed 20693876Loftus RW, Yeager MP, Clark JA, Brown JR, Abdu WA, Sengupta DK, Beach ML. Intraoperative ketamine reduces perioperative opiate consumption in opiate-dependent patients with chronic back pain undergoing back surgery. Anesthesiology. 2010 Sep;113(3):639-46. doi: 10.1097/ALN.0b013e3181e90914.
- Individual participant dataSharing planned: Yes
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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.
John Ard, MD principal investigator
NYU School of Medicine
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 Ketamine in people with Postoperative Pain, run by NYU Langone Health 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 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. 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.
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 14 Jun 2017). 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?
Scores on Questionnaires (time frame: Post-op Day 3). 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 NCT02424591, which also lists 6 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 14 Jun 2017.