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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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:
- compare pain scores in the post operative period between the two groups.
- compare morphine equivalent required in the postoperative period
- compare patient satisfaction with pain control in the post operative period
- compare physical exam findings such as joint range of motion in the post operative period
- 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 group | Role | What they receive |
|---|---|---|
| Adductor Canal Block | Experimental | Patients 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 Injection | Sham comparator | Patients 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.
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
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
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
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)
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
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.
- First posted15 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- 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)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Charters, MD, Henry Ford Health System
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02740192
- Acronym / sponsor ID
- 10221
- Conditions
- Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 15 Apr 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 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.
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:
- compare pain scores in the post operative period between the two groups.
- compare morphine equivalent required in the postoperative period
- compare patient satisfaction with pain control in the post operative period
- compare physical exam findings such as joint range of motion in the post operative period
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Block | Experimental | Procedure: Adductor Canal Block, Procedure: Periarticular Injection, Drug: Ropivacaine, Drug: BupivacainePatients in this group received local infiltration of bupivacaine in the adductor canal after surgery, in addition to the periarticular injection intra-op. |
| Periarticular Injection | Sham comparator | Procedure: Periarticular Injection, Drug: RopivacainePatients in this group received a bandaid at the presumed adductor canal injection site, in addition to the periarticular injection intra-op. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 18 scheduled for primary total knee arthroplasty by four fellowship trained surgeons will be eligible for inclusion.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Adductor Canal BlockPost-op adductor canal block using Bupivacaine | Procedure or surgery | Adductor Canal Block |
| Periarticular InjectionIntra-op periarticular injection of Ropivacaine | Procedure or surgery | Adductor Canal Block, Periarticular Injection |
| RopivacaineAlso: NaropinRopivacaine was used for the periarticular injection | Drug | Adductor Canal Block, Periarticular Injection |
| BupivacaineAlso: MarcaineBupivacaine was used for the periarticular injection | Drug | Adductor Canal Block |
Primary outcome
Post-operative pain level (Visual Analog Scale)
Time frame: Through study completion, an average of 3 days
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.
Knee flexion and extension Range of Motion (ROM)
Time frame: Through study completion, an average of 3 days
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.
Distance Walked (meters)
Time frame: Through study completion, an average of 3 days
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.
Pain with Ambulation (VAS)
Time frame: Through study completion, an average of 3 days
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.
2 secondary outcomes
Pain Medication Intake
Time frame: Through study completion, an average of 3 days
Time to discharge readiness
Time frame: Through study completion, an average of 3 days
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 30 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.