Arthropathy of KneePhase 4NCT03921034
IPACK Nerve Block for Total Knee Arthroplasty
A Phase 4 study testing Ropivacaine and Saline in people with Arthropathy of Knee and Anesthesia, run by Ochsner Health System.
Trial summary
Double-blind, randomized controlled clinical trial to test the efficacy of IPACK on postoperative opioid consumption, patient satisfaction, pain scores, mobility, and several other secondary outcomes in adults undergoing primary unilateral TKA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthropathy of Knee, Anesthesia
- What is being tested?
- Ropivacaine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 17 Nov 2016to 23 Jan 2018
- Phase
- Phase 4
- 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, primary tricompartment total knee arthroplasty
- Age 18 years or older
- ASA I-III
- Eligible for spinal or combined spinal epidural anesthetic
- Able to speak, read, and understand English
- Willing to participate in the trial
Who cannot join
- Contraindication to regional anesthesia or peripheral nerve blocks
- Allergy to local anesthetics
- Allergy to NSAIDs
- Chronic renal insufficiency with Cr > 1.4 or GFR < 60
- Have chronic pain that is not related to their knee joint
- Have been using opioids on a chronic basis (daily or almost daily opioid use for 3 months or longer)
- Have a pre-existing peripheral neuropathy involving the operative site
- Body mass index greater than or equal to 40
About this study
Official title: Pain After Total Knee Arthroplasty: a Comparison of Combined Continuous Adductor Canal Block With Infiltration of Local Anesthetic Between the Popliteal Artery and Capsule of the Knee Block Versus Continuous Adductor Canal Block Alone on Postoperative Analgesia
Double-blind, randomized controlled clinical trial to test the efficacy of IPACK on postoperative opioid consumption, patient satisfaction, pain scores, mobility, and several other secondary outcomes in adults undergoing primary unilateral TKA.
Enrolled patients will be randomized to either continuous ACB with IPACK or to continuous ACB with sham subcutaneous saline injection. Outcomes assessors and patients will be blinded to the intervention.
- Conditions
- Arthropathy of Knee, Anesthesia
- Being tested
- Ropivacaine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.
SalineDrug
All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.
| Study group | Role | What they receive |
|---|---|---|
| continuous ACB with IPACK block | Active comparator | ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and IPACK block with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine Receives: Drug: Ropivacaine |
| continuous ACB with sham subcutaneous saline injection | Sham comparator | ACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and a sham IPACK block with subcutaneous saline injection along the medial thigh Receives: Drug: Ropivacaine; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption (morphine equivalents) in the first 24 hours
Measured: 24 hours
Secondary outcomes (11)
Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey
Measured: through study completion approximately 2 days
Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
Measured: through study completion approximately 2 days
Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
Measured: through study completion approximately 2 days
Walk distance on POD#1 am, POD#1 pm, POD#2
Measured: through study completion approximately 2 days
Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room
Measured: through study completion approximately 2 days
Time to oral-only opioids
Measured: through study completion approximately 2 days
Pain location
Measured: through study completion approximately 2 days
Hospital length of stay
Measured: through study completion approximately 2 days
Incidence of foot drop
Measured: through study completion approximately 2 days
Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm
Measured: through study completion approximately 2 days
Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score
Measured: through study completion approximately 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start17 Nov 2016
- Primary completion23 Jan 2018
- Study completion23 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthropathy of 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Patterson, Ochsner Health System
- Investigators
- Matthew Patterson, MD, Principal investigator, Ochsner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921034
- Sponsor's protocol ID
- 2016.307.C
- Status last verified
- Apr 2019
- First submitted
- 10 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain After Total Knee Arthroplasty: a Comparison of Combined Continuous Adductor Canal Block With Infiltration of Local Anesthetic Between the Popliteal Artery and Capsule of the Knee Block Versus Continuous Adductor Canal Block Alone on Postoperative Analgesia
- ClinicalTrials.gov ID
- NCT03921034
- Acronym / sponsor ID
- 2016.307.C
- Conditions
- Arthropathy of Knee, Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 17 Nov 2016 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 23 Jan 2018 (actual)
- First posted
- 19 Apr 2019 (actual)
- 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.
Double-blind, randomized controlled clinical trial to test the efficacy of IPACK on postoperative opioid consumption, patient satisfaction, pain scores, mobility, and several other secondary outcomes in adults undergoing primary unilateral TKA.
Enrolled patients will be randomized to either continuous ACB with IPACK or to continuous ACB with sham subcutaneous saline injection. Outcomes assessors and patients will be blinded to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous ACB with IPACK block | Active comparator | Drug: RopivacaineACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and IPACK block with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine |
| continuous ACB with sham subcutaneous saline injection | Sham comparator | Drug: Ropivacaine, Drug: SalineACB bolused with 20 ml of ropivacaine 0.25% with 1:300,000 epinephrine followed by an 8 ml/hr continuous infusion of ropivacaine 0.2% and a sham IPACK block with subcutaneous saline injection along the medial thigh |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Unilateral, primary tricompartment total knee arthroplasty
- Age 18 years or older
- ASA I-III
- Eligible for spinal or combined spinal epidural anesthetic
- Able to speak, read, and understand English
Key exclusion criteria (8 listed)
- Contraindication to regional anesthesia or peripheral nerve blocks
- Allergy to local anesthetics
- Allergy to NSAIDs
- Chronic renal insufficiency with Cr > 1.4 or GFR < 60
- Have chronic pain that is not related to their knee joint
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 |
|---|---|---|
| RopivacaineAlso: NaropinAll patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily. | Drug | continuous ACB with IPACK block, continuous ACB with sham subcutaneous saline injection |
| SalineAll patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily. | Drug | continuous ACB with sham subcutaneous saline injection |
Primary outcome
Cumulative opioid consumption (morphine equivalents) in the first 24 hours
Time frame: 24 hours
11 secondary outcomes
Patient satisfaction on day of discharge using the Brief Pain Inventory (BPI) or a similar validated satisfaction survey
Time frame: through study completion approximately 2 days
Average pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
Time frame: through study completion approximately 2 days
Worst pain score at rest and with physical therapy in PACU, POD#1 am, POD#1 pm
Time frame: through study completion approximately 2 days
Walk distance on POD#1 am, POD#1 pm, POD#2
Time frame: through study completion approximately 2 days
Time to first intravenous opioid, oral opioid in PACU and after arrival to hospital room
Time frame: through study completion approximately 2 days
Time to oral-only opioids
Time frame: through study completion approximately 2 days
Pain location
Time frame: through study completion approximately 2 days
Hospital length of stay
Time frame: through study completion approximately 2 days
Incidence of foot drop
Time frame: through study completion approximately 2 days
Incidence of itching, nausea, or vomiting in PACU, POD#1am, POD#1 pm
Time frame: through study completion approximately 2 days
Incidence of over-sedation based on Richmond Agitation Sedation (RASS) score
Time frame: through study completion approximately 2 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 19 Apr 2019.
- Individual participant dataSharing planned: No. No plan
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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.
Matthew Patterson, MD principal investigator
Ochsner
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine and Saline in people with Arthropathy of Knee and Anesthesia, run by Ochsner Health System.
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 6 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 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Cumulative opioid consumption (morphine equivalents) in the first 24 hours (time frame: 24 hours). 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 19 Apr 2019.