Post-Operative PainNCT02701114
Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty
A study testing Proximal Adductor Canal Block and Distal Adductor Canal Block in people with Post-Operative Pain, run by Benaroya Research Institute at 1 site in United States.
Trial summary
This study is designed to evaluate pain control of continuous adductor canal blocks placed proximally versus distally within the canal. The investigators hypothesize that there will be similar pain control between both groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Operative Pain
- What is being tested?
- Proximal Adductor Canal Block and Distal Adductor Canal Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Nov 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral Total Knee Arthroplasty
- ASA physical status I-III
- >18 years old
- Non-pregnant
- Consent to participate in the study
Who cannot join
- Refusal to participate
- <18 years old
- Chronic opioid use
- Localized infection Pregnancy Pre-existing coagulopathy Allergy to ultrasound gel or local anesthetics Contraindication to or refusal of spinal anesthetic
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: A Comparison of Proximal Versus Distal Continuous Adductor Canal Blocks After Total Knee Arthroplasty
This study is designed to evaluate pain control of continuous adductor canal blocks placed proximally versus distally within the canal. The investigators hypothesize that there will be similar pain control between both groups.
Read the detailed description
This study is a non-inferiority trial designed to determine whether placement of a continuous block within the adductor canal has a substantial impact on pain following total knee arthroplasty. Our primary outcome to determine this difference will be opioid consumption within the first day following surgery. Secondary outcomes will include: pain scores, quadriceps strength, and distance ambulated during physical therapy.
- Conditions
- Post-Operative Pain
- Being tested
- Proximal Adductor Canal Block, Distal Adductor Canal Block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal Adductor Canal BlockProcedure or surgery
Continuous Nerve Block
Distal Adductor Canal BlockProcedure or surgery
Continuous Nerve Block
| Study group | Role | What they receive |
|---|---|---|
| Proximal | Active comparator | Proximal Adductor Canal Block Receives: Procedure: Proximal Adductor Canal Block |
| Distal | Active comparator | Distal Adductor Canal Block Receives: Procedure: Distal Adductor Canal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption (IV Morphine Equivalents)
Total opioid consumption
Measured: 24 Hours
Secondary outcomes (4)
Opioid Consumption (IV Morphine Equivalents)
Total opioid consumption
Measured: 48 Hours
Pain (Numeric Rating)
NRS Pain Scale
Measured: 48 Hours
Quadriceps Strength (% of Baseline)
Maximum Isometric Voluntary Contraction
Measured: 48 Hours
Distance Ambulated (Feet)
Total distance ambulated during physical therapy
Measured: 48 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Operative PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benaroya Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Hanson, Benaroya Research Institute
- Investigators
- Neil A Hanson, MD, Principal investigator, Virginia Mason Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701114
- Sponsor's protocol ID
- IRB15118
- Status last verified
- Jul 2017
- First submitted
- 29 Feb 2016
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Meier AW, Auyong DB, Yuan SC, Lin SE, Flaherty JM, Hanson NA. Comparison of Continuous Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty: A Randomized, Double-Blind, Noninferiority Trial. Reg Anesth Pain Med. 2018 Jan;43(1):36-42. doi: 10.1097/AAP.0000000000000692.
PubMed 29140959
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Proximal Versus Distal Continuous Adductor Canal Blocks After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02701114
- Acronym / sponsor ID
- IRB15118
- Conditions
- Post-Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Benaroya Research InstituteUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Mar 2016 (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.
This study is designed to evaluate pain control of continuous adductor canal blocks placed proximally versus distally within the canal. The investigators hypothesize that there will be similar pain control between both groups.
Detailed description
This study is a non-inferiority trial designed to determine whether placement of a continuous block within the adductor canal has a substantial impact on pain following total knee arthroplasty. Our primary outcome to determine this difference will be opioid consumption within the first day following surgery. Secondary outcomes will include: pain scores, quadriceps strength, and distance ambulated during physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal | Active comparator | Procedure: Proximal Adductor Canal BlockProximal Adductor Canal Block |
| Distal | Active comparator | Procedure: Distal Adductor Canal BlockDistal Adductor Canal Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral Total Knee Arthroplasty
- ASA physical status I-III
- >18 years old
- Non-pregnant
- Consent to participate in the study
Key exclusion criteria (4 listed)
- Refusal to participate
- <18 years old
- Chronic opioid use
- Localized infection Pregnancy Pre-existing coagulopathy Allergy to ultrasound gel or local anesthetics Contraindication to or refusal of spinal anesthetic
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 |
|---|---|---|
| Proximal Adductor Canal BlockContinuous Nerve Block | Procedure or surgery | Proximal |
| Distal Adductor Canal BlockContinuous Nerve Block | Procedure or surgery | Distal |
Primary outcome
Opioid Consumption (IV Morphine Equivalents)
Time frame: 24 Hours
Total opioid consumption
4 secondary outcomes
Opioid Consumption (IV Morphine Equivalents)
Time frame: 48 Hours
Pain (Numeric Rating)
Time frame: 48 Hours
Quadriceps Strength (% of Baseline)
Time frame: 48 Hours
Distance Ambulated (Feet)
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 13 Jul 2017.
- Derived from this study: PubMed 29140959Meier AW, Auyong DB, Yuan SC, Lin SE, Flaherty JM, Hanson NA. Comparison of Continuous Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty: A Randomized, Double-Blind, Noninferiority Trial. Reg Anesth Pain Med. 2018 Jan;43(1):36-42. doi: 10.1097/AAP.0000000000000692.
- Individual participant dataSharing planned: Undecided
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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.
Neil A Hanson, MD principal investigator
Virginia Mason Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal Adductor Canal Block and Distal Adductor Canal Block in people with Post-Operative Pain, run by Benaroya Research Institute 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 5 inclusion and 4 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 13 Jul 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.
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?
Opioid Consumption (IV Morphine Equivalents) (time frame: 24 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 NCT02701114, 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 13 Jul 2017.