Unilateral Knee ArthroplastyPhase 4IVAMNCT02449369

Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee

A Phase 4 study testing Preop acetaminophen IV, Preop orphenadrine IV and Postop oral oxycodone & acetaminophen in people with Unilateral Knee Arthroplasty, run by AdventHealth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a prospective, three-arm, randomized, open-label trial to determine if a new pain control protocol which includes regular dosing of intravenous acetaminophen and orphenadrine for 48 hours after total knee surgery reduces the need for opioid pain medication and reduces average pain scores. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Unilateral Knee Arthroplasty
What is being tested?: Preop acetaminophen IV, Preop orphenadrine IV and Postop oral oxycodone & acetaminophen
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 1 siteUnited States
Study dates: Apr 2015to Sep 2016
Phase: Phase 4
Are there results?: None posted in the registry

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 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 18-85
Primary, unilateral total knee arthroplasty
American Society of Anesthesiologist (ASA) physical status I, II, or III

Who cannot join

Chronic pain (as determined by regular opioid use in the month preceding surgery)
Preoperative use of centrally acting muscle relaxants in the 24 hours preceding surgery
Peripheral regional anesthesia procedures other than femoral nerve injections or catheters for postoperative pain control (such as popliteal block)
Severe renal dysfunction, creatinine > 2.0
Allergy or other contraindications to use of orphenadrine and/or acetaminophen
Pregnant or breast feeding

Show all 9Show fewer

Abnormal Liver Function Tests(LFT) and / or history of chronic/excessive alcohol abuse.
History of Hepatitis, B or C,
History of cirrhosis or hepatic insufficiency

Trial locations and contacts

1 site in 1 country.

United States1 site

Florida Hospital Winter Park
Winter Park, Florida, 32792

Other trials in United States

About this study

Official title: Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee Arthroplasty (TKA). Prospective, Randomized, Open-label Trial to Determine if Switching From Oral to Intravenous Acetaminophen and Orphenadrine for 48 Hours After TKA Improves Outcomes.

Read the detailed description

This research will be a prospective, three-arm, randomized, open-label trial to assess opioid use and patient reported outcomes after 48 hours of regular IV acetaminophen and muscle relaxant (IVAM) orphenadrine administration following total knee replacement surgery. 180 patients (60 in each arm) will be randomized to receive the standard group treatment, the IVAM group treatment, or to the control grouptreatment.

Standard Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours) as requested by the surgeon; preoperative (single dose) intravenous acetaminophen (1000 mg) and orphenadrine (60 mg); intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; postoperative oral oxycodone (5 mg) with acetaminophen (325 mg) (PRN dosing), oral orphenadrine (100 mg) every 12 hours for 3 doses, and intravenous hydromorphone (PRN dosing) for breakthrough pain.

Control Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours); preoperative (single dose) intravenous acetaminophen (1000 mg) intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; and postoperative oral oxycodone and acetaminophen (PRN dosing), and intravenous hydromorphone (PRN dosing) for breakthrough pain.

IVAM Group Treatment: includes peripheral nerve single injection or catheter infusions (48 hours); preoperative intravenous acetaminophen (1000 mg) and orphenadrine (60 mg); intraoperative spinal anesthesia or general anesthesia as determined by the anesthesia attending physician; postoperative intravenous acetaminophen (1000 mg) every 6 hours routine for total of 8 doses and intravenous orphenadrine (60 mg) every 12 hours for total of 4 doses; oral oxycodone (5 mg) (PRN dosing), and intravenous hydromorphone (PRN dosing) for breakthrough pain.

Conditions: Unilateral Knee Arthroplasty
Being tested: Preop acetaminophen IV, Preop orphenadrine IV, Postop oral oxycodone & acetaminophen, Postop hydromorphone IV, Postop oral orphenadrine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Preop acetaminophen IVDrug
Also called Ofirmev
Preop orphenadrine IVDrug
Also called Norflex
Postop oral oxycodone & acetaminophenDrug
Also called Percocet
Postop hydromorphone IVDrug
Also called Dilaudid
Postop oral orphenadrineDrug
Also called Norflex
Postop oral oxycodoneDrug
Also called Roxicodone
Postop acetaminophen IVDrug
Also called Ofirmev
Postop orphenadrine IVDrug
Also called Norflex

Study groups in NCT02449369
Study group	Role	What they receive
Control	Active comparator	Preop acetaminophen IV 1000 mg, Postop oral oxycodone \& acetaminophen (5/325 mg) 1 to 2 tabs every 4 hours PRN, and Postop hydromorphone IV 0.5 mg every 4 hours PRN Receives: Drug: Preop acetaminophen IV; Drug: Postop oral oxycodone & acetaminophen; Drug: Postop hydromorphone IV
Standard	Active comparator	Preop acetaminophen IV 1000 mg, Preop orphenadrine IV 60 mg, Postop oral orphenadrine 100 mg every 12 hours for 3 doses, Postop oral oxycodone \& acetaminophen (5/325 mg) 1 to 2 tabs every 4 hours PRN, Postop hydromorphone IV 0.5 mg every 4 hours PRN Receives: Drug: Preop acetaminophen IV; Drug: Preop orphenadrine IV; Drug: Postop oral oxycodone & acetaminophen; Drug: Postop hydromorphone IV; Drug: Postop oral orphenadrine
IVAM	Experimental	Preop acetaminophen IV 1000 mg, Preop orphenadrine IV 60 mg, Postop acetaminophen IV 1000 mg every 6 hours for 7 doses, Postop orphenadrine IV 60 mg every 12 hours for 3 doses, Postop oral oxycodone 5 mg 1 to 2 tabs every 4 hours PRN, Postop hydromorphone IV 0.5 mg every 4 hours PRN Receives: Drug: Preop acetaminophen IV; Drug: Preop orphenadrine IV; Drug: Postop hydromorphone IV; Drug: Postop oral oxycodone; Drug: Postop acetaminophen IV; Drug: Postop orphenadrine IV

What is being measured

The primary outcome is the main question the study is designed to answer.

Routine Pain Intensity Scores
verbal subjective assessment by patient reported to nursing at standard assessment times as an ordinal number between 0 and 10 (inclusive) where 0 is no pain and 10 is the maximum pain imaginable
Measured: 48 hours
Abbreviated Pain Intensity Scores
Verbal subjective assessment by patient reported to nursing at standard assessment times as either "mild", "moderate", or "severe".
Measured: 48 hours
Opioid Consumption,
recorded by nursing with dose and time. Cumulative and total opioid consumption will be analyzed.
Measured: 48 hours
Physical therapy metrics/goals
measured and recorded by physical therapist in daily chart notes quantifying ability to get out of bed, range of motion (in flexion/extension degrees) and average and maximum ambulation (in feet) during postoperative days 0 to 2.
Measured: 48 hours

Secondary outcomes (4)

PACU discharge
Time to discharge from the PACU will be measured from PACU arrival to time of PACU discharge criteria met in minutes.
Measured: 48 hours
Hospital Discharge
Time to discharge from the hospital will be measured from time/date of surgical incision to time/date that hospital discharge criteria is met, measured in hours.
Measured: 48 hours
Patient satisfaction
19 point validated questionnaire of perioperative satisfaction with items for regional anesthesia
Measured: 48 hours
Cost as measured by
study medication acquisition cost reported by pharmacy, study medication administration cost reported by pharmacy and nursing, length of stay cost reported by hospital accounting.
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2015Sep 2016

First posted20 May 2015 (estimated)
Study startApr 2015
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Unilateral Knee ArthroplastyStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02449369
Sponsor's protocol ID: 521770
Acronym: IVAM
Status last verified: Aug 2017
First submitted: 14 May 2015
Last updated: 31 Aug 2017
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Looke TD, Kluth CT. Effect of preoperative intravenous methocarbamol and intravenous acetaminophen on opioid use after primary total hip and knee replacement. Orthopedics. 2013 Feb;36(2 Suppl):25-32. doi: 10.3928/01477447-20130122-54.
PubMed 23379573
Hidalgo DA, Pusic AL. The role of methocarbamol and intercostal nerve blocks for pain management in breast augmentation. Aesthet Surg J. 2005 Nov-Dec;25(6):571-5. doi: 10.1016/j.asj.2005.09.003.
PubMed 19338859
Schneider MS. Methocarbamol: adjunct therapy for pain management in breast augmentation. Aesthet Surg J. 2002 Jul;22(4):380-1. doi: 10.1067/maj.2002.126750.
PubMed 19331993
Schneider MS. Pain reduction in breast augmentation using methocarbamol. Aesthetic Plast Surg. 1997 Jan-Feb;21(1):23-4. doi: 10.1007/s002669900076.
PubMed 9204163
Gombotz H, Lochner R, Sigl R, Blasl J, Herzer G, Trimmel H. Opiate sparing effect of fixed combination of diclophenac and orphenadrine after unilateral total hip arthroplasty: A double-blind, randomized, placebo-controlled, multi-centre clinical trial. Wien Med Wochenschr. 2010 Nov;160(19-20):526-34. doi: 10.1007/s10354-010-0829-7. Epub 2010 Oct 8.
PubMed 20890791
Malek J, Nedelova I, Lopourova M, Stefan M, Kostal R. [Diclofenac 75mg. and 30 mg. orfenadine (Neodolpasse) versus placebo and piroxicam in postoperative analgesia after arthroscopy]. Acta Chir Orthop Traumatol Cech. 2004;71(2):80-3. Czech.
PubMed 15151094
Sinatra RS, Jahr JS, Reynolds L, Groudine SB, Royal MA, Breitmeyer JB, Viscusi ER. Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis. Pain Pract. 2012 Jun;12(5):357-65. doi: 10.1111/j.1533-2500.2011.00514.x. Epub 2011 Oct 19.
PubMed 22008309
Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005 Apr;102(4):822-31. doi: 10.1097/00000542-200504000-00019.
PubMed 15791113
Korkmaz Dilmen O, Tunali Y, Cakmakkaya OS, Yentur E, Tutuncu AC, Tureci E, Bahar M. Efficacy of intravenous paracetamol, metamizol and lornoxicam on postoperative pain and morphine consumption after lumbar disc surgery. Eur J Anaesthesiol. 2010 May;27(5):428-32. doi: 10.1097/EJA.0b013e32833731a4.
PubMed 20173643
Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.
PubMed 22524979
Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2.
PubMed 23221859

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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Effectiveness of Exparel Anesthetic Administered by the Surgeon During Knee Surgery
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RecruitingPhase 1/2
Total Intravenous Anesthesia vs Spinal Anesthesia in Patients Undergoing Unilateral Primary Total Knee Arthroplasty
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Enrolling by invitationPhase 4
Pilot Study on EXPAREL as an Intra-articular Posteromedial Surgeon Administered (IPSA) Block vs. Local Infiltration Analgesia in Knee Replacement Surgery
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All Unilateral Knee Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee Arthroplasty (TKA). Prospective, Randomized, Open-label Trial to Determine if Switching From Oral to Intravenous Acetaminophen and Orphenadrine for 48 Hours After TKA Improves Outcomes.
ClinicalTrials.gov ID: NCT02449369
Acronym / sponsor ID: IVAM / 521770
Conditions: Unilateral Knee Arthroplasty
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: AdventHealthUniversity, hospital or other
Collaborators: Sagent Pharmaceuticals Inc.
Study start: Apr 2015
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 20 May 2015 (estimated)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control	Active comparator	Drug: Preop acetaminophen IV, Drug: Postop oral oxycodone & acetaminophen, Drug: Postop hydromorphone IVPreop acetaminophen IV 1000 mg, Postop oral oxycodone \& acetaminophen (5/325 mg) 1 to 2 tabs every 4 hours PRN, and Postop hydromorphone IV 0.5 mg every 4 hours PRN
Standard	Active comparator	Drug: Preop acetaminophen IV, Drug: Preop orphenadrine IV, Drug: Postop oral oxycodone & acetaminophen, Drug: Postop hydromorphone IV, Drug: Postop oral orphenadrinePreop acetaminophen IV 1000 mg, Preop orphenadrine IV 60 mg, Postop oral orphenadrine 100 mg every 12 hours for 3 doses, Postop oral oxycodone \& acetaminophen (5/325 mg) 1 to 2 tabs every 4 hours PRN, Postop hydromorphone IV 0.5 mg every 4 hours PRN
IVAM	Experimental	Drug: Preop acetaminophen IV, Drug: Preop orphenadrine IV, Drug: Postop hydromorphone IV, Drug: Postop oral oxycodone, Drug: Postop acetaminophen IV, Drug: Postop orphenadrine IVPreop acetaminophen IV 1000 mg, Preop orphenadrine IV 60 mg, Postop acetaminophen IV 1000 mg every 6 hours for 7 doses, Postop orphenadrine IV 60 mg every 12 hours for 3 doses, Postop oral oxycodone 5 mg 1 to 2 tabs every 4 hours PRN, Postop hydromorphone IV 0.5 mg every 4 hours PRN

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 18-85
Primary, unilateral total knee arthroplasty
American Society of Anesthesiologist (ASA) physical status I, II, or III

Key exclusion criteria (9 listed)

Chronic pain (as determined by regular opioid use in the month preceding surgery)
Preoperative use of centrally acting muscle relaxants in the 24 hours preceding surgery
Peripheral regional anesthesia procedures other than femoral nerve injections or catheters for postoperative pain control (such as popliteal block)
Severe renal dysfunction, creatinine > 2.0
Allergy or other contraindications to use of orphenadrine and/or acetaminophen

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
Preop acetaminophen IVAlso: Ofirmev	Drug	Control, IVAM, Standard
Preop orphenadrine IVAlso: Norflex	Drug	IVAM, Standard
Postop oral oxycodone & acetaminophenAlso: Percocet	Drug	Control, Standard
Postop hydromorphone IVAlso: Dilaudid	Drug	Control, IVAM, Standard
Postop oral orphenadrineAlso: Norflex	Drug	Standard
Postop oral oxycodoneAlso: Roxicodone	Drug	IVAM
Postop acetaminophen IVAlso: Ofirmev	Drug	IVAM
Postop orphenadrine IVAlso: Norflex	Drug	IVAM

Primary outcome

Routine Pain Intensity Scores
Time frame: 48 hours
verbal subjective assessment by patient reported to nursing at standard assessment times as an ordinal number between 0 and 10 (inclusive) where 0 is no pain and 10 is the maximum pain imaginable
Abbreviated Pain Intensity Scores
Time frame: 48 hours
Verbal subjective assessment by patient reported to nursing at standard assessment times as either "mild", "moderate", or "severe".
Opioid Consumption,
Time frame: 48 hours
recorded by nursing with dose and time. Cumulative and total opioid consumption will be analyzed.
Physical therapy metrics/goals
Time frame: 48 hours
measured and recorded by physical therapist in daily chart notes quantifying ability to get out of bed, range of motion (in flexion/extension degrees) and average and maximum ambulation (in feet) during postoperative days 0 to 2.

4 secondary outcomes

PACU discharge
Time frame: 48 hours
Hospital Discharge
Time frame: 48 hours
Patient satisfaction
Time frame: 48 hours
Cost as measured by
Time frame: 48 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
Results publication: PubMed 23379573Looke TD, Kluth CT. Effect of preoperative intravenous methocarbamol and intravenous acetaminophen on opioid use after primary total hip and knee replacement. Orthopedics. 2013 Feb;36(2 Suppl):25-32. doi: 10.3928/01477447-20130122-54.
Results publication: PubMed 19338859Hidalgo DA, Pusic AL. The role of methocarbamol and intercostal nerve blocks for pain management in breast augmentation. Aesthet Surg J. 2005 Nov-Dec;25(6):571-5. doi: 10.1016/j.asj.2005.09.003.
Results publication: PubMed 19331993Schneider MS. Methocarbamol: adjunct therapy for pain management in breast augmentation. Aesthet Surg J. 2002 Jul;22(4):380-1. doi: 10.1067/maj.2002.126750.
Results publication: PubMed 9204163Schneider MS. Pain reduction in breast augmentation using methocarbamol. Aesthetic Plast Surg. 1997 Jan-Feb;21(1):23-4. doi: 10.1007/s002669900076.
Results publication: PubMed 20890791Gombotz H, Lochner R, Sigl R, Blasl J, Herzer G, Trimmel H. Opiate sparing effect of fixed combination of diclophenac and orphenadrine after unilateral total hip arthroplasty: A double-blind, randomized, placebo-controlled, multi-centre clinical trial. Wien Med Wochenschr. 2010 Nov;160(19-20):526-34. doi: 10.1007/s10354-010-0829-7. Epub 2010 Oct 8.
Results publication: PubMed 15151094Malek J, Nedelova I, Lopourova M, Stefan M, Kostal R. [Diclofenac 75mg. and 30 mg. orfenadine (Neodolpasse) versus placebo and piroxicam in postoperative analgesia after arthroscopy]. Acta Chir Orthop Traumatol Cech. 2004;71(2):80-3. Czech.
Results publication: PubMed 22008309Sinatra RS, Jahr JS, Reynolds L, Groudine SB, Royal MA, Breitmeyer JB, Viscusi ER. Intravenous acetaminophen for pain after major orthopedic surgery: an expanded analysis. Pain Pract. 2012 Jun;12(5):357-65. doi: 10.1111/j.1533-2500.2011.00514.x. Epub 2011 Oct 19.
Results publication: PubMed 15791113Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005 Apr;102(4):822-31. doi: 10.1097/00000542-200504000-00019.
Results publication: PubMed 20173643Korkmaz Dilmen O, Tunali Y, Cakmakkaya OS, Yentur E, Tutuncu AC, Tureci E, Bahar M. Efficacy of intravenous paracetamol, metamizol and lornoxicam on postoperative pain and morphine consumption after lumbar disc surgery. Eur J Anaesthesiol. 2010 May;27(5):428-32. doi: 10.1097/EJA.0b013e32833731a4.
Results publication: PubMed 22524979Singla NK, Parulan C, Samson R, Hutchinson J, Bushnell R, Beja EG, Ang R, Royal MA. Plasma and cerebrospinal fluid pharmacokinetic parameters after single-dose administration of intravenous, oral, or rectal acetaminophen. Pain Pract. 2012 Sep;12(7):523-32. doi: 10.1111/j.1533-2500.2012.00556.x. Epub 2012 Apr 24.
Results publication: PubMed 23221859Maurice-Szamburski A, Bruder N, Loundou A, Capdevila X, Auquier P. Development and validation of a perioperative satisfaction questionnaire in regional anesthesia. Anesthesiology. 2013 Jan;118(1):78-87. doi: 10.1097/ALN.0b013e31827469f2.
Individual participant dataSharing planned: No

Related trials for Unilateral Knee Arthroplasty

RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
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RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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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.

thomas Looke, MD principal investigator

AdventHealth

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 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 31 Aug 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Routine Pain Intensity Scores (time frame: 48 hours). The study lists 4 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 NCT02449369, which also lists 11 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 31 Aug 2017.