Osteo Arthritis KneeNCT03395990
Analgesic Value of Adductor Canal vs Femoral Block After Total Knee Arthroplasty
A study testing Active comparator: chloroprocaine in people with Osteo Arthritis Knee, run by Duke University at 1 site in United States.
Trial summary
An observational study of the effect of femoral nerve block in addition to an adductor canal block for pain following total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 56 to 85 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Active comparator: chloroprocaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2016to 19 Oct 2016
- 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 56 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective total knee arthroplasty
- ASA Physical Status I-III
- BMI 18-40 kg/m2
Who cannot join
- Inability to cooperate with protocol
- Inability to understand or speak English
- Allergy to any local anesthetic
- Chronic opioid consumption/abuse (30 or more morphine mg equivalents/day)
- Contraindication to adductor canal or femoral nerve block
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27710
About this study
Official title: Evaluation of the Comparative Analgesic Value of Adductor Canal Block Versus Femoral Block Following Total Knee Arthroplasty
An observational study of the effect of femoral nerve block in addition to an adductor canal block for pain following total knee arthroplasty.
Read the detailed description
Subjects undergoing total knee arthroplasty will receive a preoperative adductor canal block with continuous catheter. Following a standardized general anesthetic for the procedure, subjects will be asked to rate their pain using the NRS-11 pain scale in the recovery room. Once the pain is reported at a 5/10 or above, a femoral nerve block will be performed using either 2% chloroprocaine or saline placebo (randomized). Pain scores are then evaluated over the next 30 minutes by a blinded investigator to determine if the femoral block adds any additional analgesic benefit over an adductor canal block.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Active comparator: chloroprocaine, Sham comparator: saline
- Keywords
- femoral nerve block, adductor canal block, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active comparator: chloroprocaineProcedure or surgery
Also called femoral nerve block with chloroprocaine
15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
Sham comparator: salineProcedure or surgery
Also called femoral nerve block with normal saline
15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
| Study group | Role | What they receive |
|---|---|---|
| chloroprocaine | Active comparator | 15 ml of 2% chloroprocaine via a femoral nerve block technique Receives: Procedure: Active comparator: chloroprocaine |
| saline | Sham comparator | 15 ml of 0.9% saline via a femoral nerve block technique Receives: Procedure: Sham comparator: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable).
Measured: Baseline, up to 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start27 Mar 2016
- Primary completion19 Oct 2016
- Study completion19 Oct 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.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Model description
- randomized, blinded observational study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeff Gadsden, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395990
- Sponsor's protocol ID
- PRO00067430
- Status last verified
- Jun 2020
- First submitted
- 18 Dec 2017
- Last updated
- 17 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Comparative Analgesic Value of Adductor Canal Block Versus Femoral Block Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03395990
- Acronym / sponsor ID
- PRO00067430
- Conditions
- Osteo Arthritis Knee
- Keywords
- femoral nerve block, adductor canal block, analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 27 Mar 2016 (actual)
- Primary completion
- 19 Oct 2016 (actual)
- Study completion
- 19 Oct 2016 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Posted 17 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An observational study of the effect of femoral nerve block in addition to an adductor canal block for pain following total knee arthroplasty.
Detailed description
Subjects undergoing total knee arthroplasty will receive a preoperative adductor canal block with continuous catheter. Following a standardized general anesthetic for the procedure, subjects will be asked to rate their pain using the NRS-11 pain scale in the recovery room. Once the pain is reported at a 5/10 or above, a femoral nerve block will be performed using either 2% chloroprocaine or saline placebo (randomized). Pain scores are then evaluated over the next 30 minutes by a blinded investigator to determine if the femoral block adds any additional analgesic benefit over an adductor canal block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, blinded observational study
| Arm | Type | Receives |
|---|---|---|
| chloroprocaine | Active comparator | Procedure: Active comparator: chloroprocaine15 ml of 2% chloroprocaine via a femoral nerve block technique |
| saline | Sham comparator | Procedure: Sham comparator: saline15 ml of 0.9% saline via a femoral nerve block technique |
Who may qualify
- Ages
- 56 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective total knee arthroplasty
- ASA Physical Status I-III
- BMI 18-40 kg/m2
Key exclusion criteria (5 listed)
- Inability to cooperate with protocol
- Inability to understand or speak English
- Allergy to any local anesthetic
- Chronic opioid consumption/abuse (30 or more morphine mg equivalents/day)
- Contraindication to adductor canal or femoral nerve block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active comparator: chloroprocaineAlso: femoral nerve block with chloroprocaine15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb. | Procedure or surgery | chloroprocaine |
| Sham comparator: salineAlso: femoral nerve block with normal saline15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb. | Procedure or surgery | saline |
Primary outcome
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain.
Time frame: Baseline, up to 30 minutes.
Pain intensity prior to intervention and at 5 minute intervals after intervention. The 11-point Numeric Rating Scale quantifies a subject's pain experience from 0/10 (no pain) to 10/10 (worst pain imaginable).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- 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.
Jeff Gadsden, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active comparator: chloroprocaine in people with Osteo Arthritis Knee, run by Duke University 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 17 Jun 2020. 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 17 Jun 2020). 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?
Pain Intensity as Measured by 11-point Verbal Numeric Rating Scale (NRS-11) for Pain. (time frame: Baseline, up to 30 minutes.). 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 17 Jun 2020.