Osteoarthritis, KneePhase 4NCT02462148
Perineural Steroids for Peripheral Nerve Blocks
A Phase 4 study testing Dexamethasone, Bupivacaine and Epinephrine in people with Osteoarthritis, Knee, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve blocks. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Dexamethasone, Bupivacaine and Epinephrine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 31 Aug 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- elective robotic medial MAKO partial knee arthroplasty
- agreed to a regional anesthesia technique
Who cannot join
- contraindications to regional anesthesia
- presence of a progressive neurological deficit
- a pre-existing coagulopathy, infection
- insulin and non-insulin dependent diabetes mellitus
- systemic use of corticosteroids within 30 days of surgery
- chronic use of an opioid analgesic (>3 months or a combined total of more than 40 mg Oxycodone equivalents a day)
- pregnancy
- a prior history of an adverse event (for example: psychosis) or an allergy to dexamethasone
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Perineural Steroids for Saphenous Peripheral Nerve Blocks: An Equivalency Dosing Study.
This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve blocks.
Read the detailed description
The purpose of this randomized, double-blinded, placebo-controlled trial is to examine if dexamethasone given perineurally as an adjuvant to the nerve block will prolong the time to recovery from sensory nerve block from a saphenous (or adductor canal) nerve block. The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. If this primary end point is met, this study will also serve as an equivalency dosing study comparing 1 mg of perineural dexamethasone to 4 mg of perineural dexamethasone.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Dexamethasone, Bupivacaine, Epinephrine, Saphenous Peripheral Nerve Block
- Keywords
- Anesthesia, Anesthesia, Conduction, Anesthesia, Local, Bupivacaine, Dexamethasone, Saphenous, Adductor Canal, Nerve Block, Analgesia, Preanesthetic Medication, Perioperative Period, Peripheral Nerve Block
- Medical subject headings
- Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Dexamethasone Sodium Phosphate Injection
Used in nerve block mixture
BupivacaineDrug
Also called Bupivacaine Hydrochloride
Used in nerve block mixture
EpinephrineDrug
Also called Adrenaline
Used in nerve block mixture
Saphenous Peripheral Nerve BlockProcedure or surgery
Also called Adductor Canal Peripheral Nerve Block
Peripheral nerve block.
| Study group | Role | What they receive |
|---|---|---|
| 4 mg Perineural Dexamethasone Group | Experimental | 4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given. Receives: Drug: Dexamethasone; Drug: Bupivacaine; Drug: Epinephrine; Procedure: Saphenous Peripheral Nerve Block |
| 1 mg Perineural Dexamethasone Group | Experimental | 1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given. Receives: Drug: Dexamethasone; Drug: Bupivacaine; Drug: Epinephrine; Procedure: Saphenous Peripheral Nerve Block |
| Placebo Group | Placebo comparator | This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural. Receives: Drug: Bupivacaine; Drug: Epinephrine; Procedure: Saphenous Peripheral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Sensory Nerve Block
The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours.
Measured: 12 to 48 hours
Secondary outcomes (5)
Verbal Pain Scores
Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours.
Measured: 0 to 30 hours
Rate of Post Operative Nausea and Vomiting
Number of participants that experienced nausea and vomiting was recorded.
Measured: 0 to 30 hours
Neurologic Complications
Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur.
Measured: throughout study completion, up to 48 hours
Post Operative Opioid Use and Consumption
Amount of opioid use and consumption was recorded.
Measured: 0-30 hours
Time to First Opioid Analgesic Request
Time it took for the first opioid analgesic request was recorded.
Measured: 0 to 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJul 2015
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daryl S Henshaw, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462148
- Sponsor's protocol ID
- IRB00032807
- Status last verified
- Sep 2018
- First submitted
- 1 Jun 2015
- Last updated
- 24 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Turner JD, Henshaw DS, Weller RS, Jaffe JD, Edwards CJ, Reynolds JW, Russell GB, Dobson SW. Perineural dexamethasone successfully prolongs adductor canal block when assessed by objective pinprick sensory testing: A prospective, randomized, dose-dependent, placebo-controlled equivalency trial. J Clin Anesth. 2018 Aug;48:51-57. doi: 10.1016/j.jclinane.2018.05.009. Epub 2018 May 9.
PubMed 29753264
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineural Steroids for Saphenous Peripheral Nerve Blocks: An Equivalency Dosing Study.
- ClinicalTrials.gov ID
- NCT02462148
- Acronym / sponsor ID
- IRB00032807
- Conditions
- Osteoarthritis, Knee
- Keywords
- Anesthesia, Anesthesia, Conduction, Anesthesia, Local, Bupivacaine, Dexamethasone, Saphenous, Adductor Canal, Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Posted 7 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve blocks.
Detailed description
The purpose of this randomized, double-blinded, placebo-controlled trial is to examine if dexamethasone given perineurally as an adjuvant to the nerve block will prolong the time to recovery from sensory nerve block from a saphenous (or adductor canal) nerve block. The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. If this primary end point is met, this study will also serve as an equivalency dosing study comparing 1 mg of perineural dexamethasone to 4 mg of perineural dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 4 mg Perineural Dexamethasone Group | Experimental | Drug: Dexamethasone, Drug: Bupivacaine, Drug: Epinephrine, Procedure: Saphenous Peripheral Nerve Block4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given. |
| 1 mg Perineural Dexamethasone Group | Experimental | Drug: Dexamethasone, Drug: Bupivacaine, Drug: Epinephrine, Procedure: Saphenous Peripheral Nerve Block1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given. |
| Placebo Group | Placebo comparator | Drug: Bupivacaine, Drug: Epinephrine, Procedure: Saphenous Peripheral Nerve BlockThis group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- elective robotic medial MAKO partial knee arthroplasty
- agreed to a regional anesthesia technique
Key exclusion criteria (8 listed)
- contraindications to regional anesthesia
- presence of a progressive neurological deficit
- a pre-existing coagulopathy, infection
- insulin and non-insulin dependent diabetes mellitus
- systemic use of corticosteroids within 30 days of surgery
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 |
|---|---|---|
| DexamethasoneAlso: Dexamethasone Sodium Phosphate InjectionUsed in nerve block mixture | Drug | 1 mg Perineural Dexamethasone Group, 4 mg Perineural Dexamethasone Group |
| BupivacaineAlso: Bupivacaine HydrochlorideUsed in nerve block mixture | Drug | 1 mg Perineural Dexamethasone Group, 4 mg Perineural Dexamethasone Group, Placebo Group |
| EpinephrineAlso: AdrenalineUsed in nerve block mixture | Drug | 1 mg Perineural Dexamethasone Group, 4 mg Perineural Dexamethasone Group, Placebo Group |
| Saphenous Peripheral Nerve BlockAlso: Adductor Canal Peripheral Nerve BlockPeripheral nerve block. | Procedure or surgery | 1 mg Perineural Dexamethasone Group, 4 mg Perineural Dexamethasone Group, Placebo Group |
Primary outcome
Duration of Sensory Nerve Block
Time frame: 12 to 48 hours
The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours.
5 secondary outcomes
Verbal Pain Scores
Time frame: 0 to 30 hours
Rate of Post Operative Nausea and Vomiting
Time frame: 0 to 30 hours
Neurologic Complications
Time frame: throughout study completion, up to 48 hours
Post Operative Opioid Use and Consumption
Time frame: 0-30 hours
Time to First Opioid Analgesic Request
Time frame: 0 to 36 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29753264Turner JD, Henshaw DS, Weller RS, Jaffe JD, Edwards CJ, Reynolds JW, Russell GB, Dobson SW. Perineural dexamethasone successfully prolongs adductor canal block when assessed by objective pinprick sensory testing: A prospective, randomized, dose-dependent, placebo-controlled equivalency trial. J Clin Anesth. 2018 Aug;48:51-57. doi: 10.1016/j.jclinane.2018.05.009. Epub 2018 May 9.
Related trials for Osteoarthritis, Knee
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
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.
Daryl S Henshaw, MD principal investigator
Wake Forest University Health Sciences
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 Dexamethasone, Bupivacaine and Epinephrine in people with Osteoarthritis, Knee, run by Wake Forest University Health Sciences 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 2 inclusion and 8 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 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 7 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Sensory Nerve Block (time frame: 12 to 48 hours). 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 NCT02462148, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2018.