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PainEarly Phase 1NCT02740192

Pain Control After Total Knee Arthroplasty: Benefit In Adding Single Shot Adductor Canal Block to Existing Pain Regimen Protocol?

A Early Phase 1 study testing Adductor Canal Block, Periarticular Injection and Ropivacaine in people with Pain, run by Henry Ford Health System 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
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Trial summary

This is a randomized, double blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring total knee arthroplasty will be eligible. The study compares pain control, opioid consumption, and physical exam findings in patients undergoing total knee arthroplasty between patients receiving… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain
What is being tested?
Adductor Canal Block, Periarticular Injection and Ropivacaine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
1 siteUnited States
Study dates
Apr 2016to Dec 2016
Phase
Early Phase 1
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

  • Patients over the age of 18 scheduled for primary total knee arthroplasty by four fellowship trained surgeons will be eligible for inclusion.

Who cannot join

  • Patients will be excluded if their medical history presents chronic opioid use (greater than 3 month use),
  • pregnancy,
  • history of intolerance to medications in the study, and substantial substance abuse.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Henry Ford Hospital

    Detroit, Michigan, 48202

Other trials in United States

About this study

Official title: Pain Control After Total Knee Arthroplasty: A Prospective, Double-blind Randomized Controlled Trial Examining the Benefit of a Combined Adductor-canal Nerve Block With Periarticular Infiltration Versus Periarticular Injection Alone

This is a randomized, double blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring total knee arthroplasty will be eligible. The study compares pain control, opioid consumption, and physical exam findings in patients undergoing total knee arthroplasty between patients receiving adductor canal block and those who receiving periarticular injection alone.

Read the detailed description

The purpose of this project is to compare the effectiveness of two different but well accepted approaches to nerve blockade in order to improve pain control after total knee arthroplasty. Specifically, this study seeks to identify the if adductor canal blockade provides additional pain relief and decreased morphine consumption when used in addition to a local infiltration of anesthetic (periarticular injection).

Aims:

  1. compare pain scores in the post operative period between the two groups.
  2. compare morphine equivalent required in the postoperative period
  3. compare patient satisfaction with pain control in the post operative period
  4. compare physical exam findings such as joint range of motion in the post operative period
  5. compare ability to participate with physical therapy in the post operative period

Total knee arthroplasty is associated with intense pain in the post operative period. Pain control is essential in this patient population. Beyond the ethical and humanitarian concerns, pain has been shown in the literature to affect outcomes after total knee replacement. Patients in pain tend to have worse range of motion, decreased participation with physical therapy, increased time to discharge, and downstream medical sequela as well. Pain has been shown to cause or exacerbate delirium in the postoperative period. Patients in pain ambulate less and stay in bed more, therefore increasing the risk of deep vein thrombosis and pulmonary embolism. Patients in pain consume more opioids, which have well known side effects, such as constipation, nausea, vomiting, pruritus, addiction, and altered mental status. Early joint range of motion prevents irreversible joint stiffness and pain, affecting long term outcomes. Pain control in patients undergoing total knee arthroplasty has improved in recent years. The current standard has become a multimodal approach, consisting of preoperative, intraoperative and post operative interventions. The multimodal approach works by preventing or addressing pain at multiple location and targets multiple different pain receptors and pain generators. There has been much attention given to injections and nerve blocks in addition to standard pain medications such as antiinflammatories, acetaminophen, and opioids. There have been many published studies investigating various medication regimens, periarticular injection cocktails, and post operative nerve blocks. These studies have shown that each modality works better than placebo. Several studies have shown that post operative blocks provide additional benefit when used in conjunction with a periarticular injection. These studies were done with femoral nerve catheters and adductor canal catheters that stay in place for several days post operative and require subsequent boluses. No studies in the literature have studied the additional benefit of a single shot adductor canal block. The rationale is that the injection given at the time of surgery should affect the same same local nerves and pain receptors as the adductor canal block, via a different technique. Therefore, the investigators believe the adductor canal block may prove to be of no additional benefit in the investigators patients.

The ultimate goal is identifying the best pain control protocol to decrease pain in the post operative period. Developing this protocol may require the addition or subtraction of various treatment modalities. This study is looking at the adductor canal block, which if found to be unnecessary will prevent patients from receiving unnecessary procedures. If found to be effective at reducing pain, then this study will provide direct evidence for using single shot adductor canal blockade in addition to the periarticular injection.

Conditions
Pain
Being tested
Adductor Canal Block, Periarticular Injection, Ropivacaine, Bupivacaine
Medical subject headings
Pain

What participants receive

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

  • Adductor Canal BlockProcedure or surgery

    Post-op adductor canal block using Bupivacaine

  • Periarticular InjectionProcedure or surgery

    Intra-op periarticular injection of Ropivacaine

  • RopivacaineDrug

    Also called Naropin

    Ropivacaine was used for the periarticular injection

  • BupivacaineDrug

    Also called Marcaine

    Bupivacaine was used for the periarticular injection

Study groups in NCT02740192
Study groupRoleWhat they receive
Adductor Canal BlockExperimentalPatients in this group received local infiltration of bupivacaine in the adductor canal after surgery, in addition to the periarticular injection intra-op.
Receives: Procedure: Adductor Canal Block; Procedure: Periarticular Injection; Drug: Ropivacaine; Drug: Bupivacaine
Periarticular InjectionSham comparatorPatients in this group received a bandaid at the presumed adductor canal injection site, in addition to the periarticular injection intra-op.
Receives: Procedure: Periarticular Injection; Drug: Ropivacaine

What is being measured

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

  1. Post-operative pain level (Visual Analog Scale)

    Patients' pain levels will be recorded every 6 hours using VAS (Visual Analog Scale) by the nursing staff from when the patient arrives on the inpatient floor to when the patient is discharged from the hospital.

    Measured: Through study completion, an average of 3 days

  2. Knee flexion and extension Range of Motion (ROM)

    Patients' knee ROM will be assessed every morning at 6:30am by the rounding physician on the inpatient floor until the patient is discharged from the hospital.

    Measured: Through study completion, an average of 3 days

  3. Distance Walked (meters)

    Patients will work with Physical Therapists 2 times day (AM and PM). Distance walked (meters) will be recorded by the Physical Therapist from postoperative day #1 until the patient is discharged from the hospital.

    Measured: Through study completion, an average of 3 days

  4. Pain with Ambulation (VAS)

    Patients will work with Physical Therapists 2 times day (AM and PM). Pain with ambulation (VAS) will be recorded by the Physical Therapist from postoperative day #1 until the patient is discharged from the hospital.

    Measured: Through study completion, an average of 3 days

Secondary outcomes (2)
  1. Pain Medication Intake

    Patients' opioid intake (oxycodone, morphine, ms contin, dilaudid, etc) will be calculated and converted to morphine equivalents. The values will be recorded by the rounding physician from when the patient arrives on the inpatient floor to when the patient is discharged from the hospital.

    Measured: Through study completion, an average of 3 days

  2. Time to discharge readiness

    Time to discharge readiness will be calculated in hours by the rounding physician from when the patient arrives on the inpatient floor to when the patient is discharged from the hospital.

    Measured: Through study completion, an average of 3 days

Timeline

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

  1. First posted15 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02740192
Sponsor's protocol ID
10221
Status last verified
Oct 2023
First submitted
24 Mar 2016
Last updated
30 Oct 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Adductor Canal Block, Periarticular Injection and Ropivacaine in people with Pain, run by Henry Ford Health System 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 1 inclusion and 3 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 30 Oct 2023. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Post-operative pain level (Visual Analog Scale) (time frame: Through study completion, an average of 3 days). 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?
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 30 Oct 2023.

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