OsteoarthritisPhase 4ACB PAINCT02292082
The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
A Phase 4 study testing Bupivacaine, Morphine and Methylprednisolone in people with Osteoarthritis, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Total knee replacement is associated with severe post-operative pain. The purpose of this study is to compare two methods of treatment for pain control following Total Knee Replacement with an accelerated physical therapy protocol to aid the achievement of rehab milestones. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Bupivacaine, Morphine and Methylprednisolone
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Aug 2016
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
- Age 18 to 80 years
- Planned use of regional anesthesia
- Ability to follow study protocol
- English speaking (secondary outcomes include questionnaires validated in English only)
Who cannot join
- Hepatic or renal insufficiency Patients younger than 18 years old and older than 80 Patients intending to receive general anesthesia Patients planning to go to rehab post operatively Patients scheduled to go into the OR after 1 pm Allergy or intolerance to one of the study medications Patients with an ASA of IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months) Diabetes Patients on workers compensation or disability
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Total knee replacement is associated with severe post-operative pain. The purpose of this study is to compare two methods of treatment for pain control following Total Knee Replacement with an accelerated physical therapy protocol to aid the achievement of rehab milestones.
Read the detailed description
A total of 106 patients undergoing total knee arthroplasty will be randomized into two groups: one to receive only Periarticular injections and the other periarticular injections AND adductor canal block.
Patients will be asked their numeric pain scores before surgery as baseline and at 24 and 48 hours post-operation. Patients also will be asked questions from painOUT questionnaire at 24 and 48 hours.
Time to reach discharge criteria based on physical therapy assessments will also be measured.
- Conditions
- Osteoarthritis
- Being tested
- Bupivacaine, Morphine, Methylprednisolone, Cefazolin, Normal saline
- Keywords
- Nerve Block, Rehabilitation, Knee Replacement, Total
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
MorphineDrug
CefazolinDrug
Normal salineDrug
MidazolamDrug
PropofolDrug
DexamethasoneDrug
8 MHz. Chiba needle, 22 G / 4 inchesDevice
| Study group | Role | What they receive |
|---|---|---|
| Peri-Articular Injections only | Active comparator | Intra-Operatively
* Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
* Surgeon will perform the periarticular injections:
* First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
* Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine
* Intravenous sedation with midazolam and propofol. Receives: Drug: Bupivacaine; Drug: Morphine; Drug: Methylprednisolone; Drug: Cefazolin; Drug: Normal saline; Drug: Midazolam; Drug: Propofol; Drug: Dexamethasone |
| Peri-Articular Injections and Adductor Canal Block | Experimental | Intra-Operatively
* Spinal anesthetic with 0.5% bupivacaine (10 or 12.5)
* Adductor canal block technique:
* Supine position, after IV sedation
* Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches
* Femoral artery will be identified in the adductor canal deep to the Sartorius muscle
* 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone
* Local anesthetic will be delivered periarterial between 12 and 6 o'clock
* Intravenous sedation with midazolam and propofol.
* First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc
* Second superficial injection prior to closure. 20 ml 0.25% bupivacaine Receives: Drug: Bupivacaine; Drug: Morphine; Drug: Methylprednisolone; Drug: Cefazolin; Drug: Normal saline; Drug: Midazolam; Drug: Propofol; Drug: Dexamethasone; Device: 8 MHz. Chiba needle, 22 G / 4 inches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Meet Physical Therapy Discharge Criteria
Time to reach physical therapy (PT) goals
Measured: First 3 days post-operatively
Secondary outcomes (10)
Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1
Patient reported pain scores on postoperative day 1 from 0-10. 0 being no pain, 10 being the worst pain imaginable.
Measured: 24 hours after operating room discharge
NRS Pain Score With Movement POD2
NRS pain with movement as reported by the patient. Rated from 0-10. 0 being no pain, 10 being the worst pain imaginable.
Measured: 48 hours after surgery
Opioid Consumption Postoperative Day (POD) 1
Opioid consumption for patients from 0-24 hours postoperative, measured in mg OME (oral morphine equivalents)
Measured: 0-24 hours postoperatively
Opioid Consumption POD2
Opioid consumption over hours 24-48 postoperatively. Measured in mg OME (oral morphine equivalents). Higher equates to more opioids consumed.
Measured: 24-48 hours postoperative
Hospital Length of Stay
Measured in minutes.
Measured: Average of 3 days
Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively
Measures: least pain in the last 24 hours. Scores are measured from 0-10. 0 being no pain to 10 being the worst pain imaginable.
Measured: Participants will be followed for the duration of 2 days post operatively in the hospital
Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively
Least pain experienced from 24-48 hours postoperative on a scale from 0-10. 0 being no pain at all to 10 being the worst pain imaginable
Measured: 24-48 hours postoperative
Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively
Painout most pain experienced 0-24 hours postoperatively, measured from 0-10. 0 being no pain to 10 being the worst pain imaginable
Measured: 0-24 hours postoperatively
Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively
Painout most pain experienced 24-48 hours postoperatively measured on a scale from 0-10. Higher scores indicate higher pain levels.
Measured: 24-48 hours postoperative
Knee Society Score (KSS) at 6 Weeks Postoperatively
KSS (Knee Society Score) score measured at 6 weeks postoperatively. The scale is from 0-100. Scores below 60 indicate poor function, 60-69 indicate fair, 70-79 indicate good, and 80-100 indicate excellent functional scores. KSS measures knee pain, flexion contracture,extension lag, alignment, stability, and total range of flexion and generates an associated score correlating to knee function. Higher is better. There is no sub score - only the cumulative Knee Society Score.
Measured: Post operatively at approximately 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionAug 2016
- Study completionAug 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 OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique A Goytizolo, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02292082
- Sponsor's protocol ID
- 2014-018
- Acronym
- ACB PAI
- Status last verified
- Jan 2019
- First submitted
- 10 Nov 2014
- Last updated
- 11 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combination of Adductor Canal Block and Periarticular Injection. A Novel Technique for Patients Undergoing Total Knee Replacement (ACB PAI)
- ClinicalTrials.gov ID
- NCT02292082
- Acronym / sponsor ID
- ACB PAI / 2014-018
- Conditions
- Osteoarthritis
- Keywords
- Nerve Block, Rehabilitation, Knee Replacement, Total
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 17 Nov 2014 (estimated)
- Results
- Posted 11 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total knee replacement is associated with severe post-operative pain. The purpose of this study is to compare two methods of treatment for pain control following Total Knee Replacement with an accelerated physical therapy protocol to aid the achievement of rehab milestones.
Detailed description
A total of 106 patients undergoing total knee arthroplasty will be randomized into two groups: one to receive only Periarticular injections and the other periarticular injections AND adductor canal block.
Patients will be asked their numeric pain scores before surgery as baseline and at 24 and 48 hours post-operation. Patients also will be asked questions from painOUT questionnaire at 24 and 48 hours.
Time to reach discharge criteria based on physical therapy assessments will also be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-Articular Injections only | Active comparator | Drug: Bupivacaine, Drug: Morphine, Drug: Methylprednisolone, Drug: Cefazolin, Drug: Normal saline, Drug: Midazolam, Drug: Propofol, Drug: DexamethasoneIntra-Operatively * Spinal anesthetic with 0.5% bupivacaine (10 or 12.5) * Surgeon will perform the periarticular injections: * First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc * Second superficial injection prior to closure. 1.20 ml 0.25% bupivacaine * Intravenous sedation with midazolam and propofol. |
| Peri-Articular Injections and Adductor Canal Block | Experimental | Drug: Bupivacaine, Drug: Morphine, Drug: Methylprednisolone, Drug: Cefazolin, Drug: Normal saline, Drug: Midazolam, Drug: Propofol, Drug: Dexamethasone, Device: 8 MHz. Chiba needle, 22 G / 4 inchesIntra-Operatively * Spinal anesthetic with 0.5% bupivacaine (10 or 12.5) * Adductor canal block technique: * Supine position, after IV sedation * Ultrasound guided with linear transducer 8 MHz. Chiba needle, 22 G / 4 inches * Femoral artery will be identified in the adductor canal deep to the Sartorius muscle * 15 cc of Bupivacaine 0.25% with 2 mg of Preservative free Dexamethasone * Local anesthetic will be delivered periarterial between 12 and 6 o'clock * Intravenous sedation with midazolam and propofol. * First deep injection prior to cementation Bupivacaine 0.5% with epinephrine, 30cc Morphine, 8 mg/ml, 1 cc Methylprednisolone, 40 mg/ml, 1 ml Cefazolin, 500 mg in 10 ml Normal saline, 22cc * Second superficial injection prior to closure. 20 ml 0.25% bupivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with osteoarthritis scheduled for primary tricompartmental total knee arthroplasty with a participating surgeon
- Age 18 to 80 years
- Planned use of regional anesthesia
- Ability to follow study protocol
- English speaking (secondary outcomes include questionnaires validated in English only)
Key exclusion criteria (1 listed)
- Hepatic or renal insufficiency Patients younger than 18 years old and older than 80 Patients intending to receive general anesthesia Patients planning to go to rehab post operatively Patients scheduled to go into the OR after 1 pm Allergy or intolerance to one of the study medications Patients with an ASA of IV Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months) Diabetes Patients on workers compensation or disability
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 |
|---|---|---|
| Bupivacaine | Drug | Peri-Articular Injections and Adductor Canal Block, Peri-Articular Injections only |
| Morphine | Drug | Peri-Articular Injections and Adductor Canal Block, Peri-Articular Injections only |
| Methylprednisolone | Drug | Peri-Articular Injections and Adductor Canal Block, Peri-Articular Injections only |
| Cefazolin | Drug | Peri-Articular Injections and Adductor Canal Block, Peri-Articular Injections only |
| Normal saline | Drug | Peri-Articular Injections and Adductor Canal Block, Peri-Articular Injections only |
| Midazolam | Drug | Peri-Articular Injections and Adductor Canal Block, Peri-Articular Injections only |
| Propofol | Drug | Peri-Articular Injections and Adductor Canal Block, Peri-Articular Injections only |
| Dexamethasone | Drug | Peri-Articular Injections and Adductor Canal Block, Peri-Articular Injections only |
| 8 MHz. Chiba needle, 22 G / 4 inches | Device | Peri-Articular Injections and Adductor Canal Block |
Primary outcome
Time to Meet Physical Therapy Discharge Criteria
Time frame: First 3 days post-operatively
Time to reach physical therapy (PT) goals
10 secondary outcomes
Numerical Rating Scale (NRS) Pain Scores With Ambulation Postoperative Day 1
Time frame: 24 hours after operating room discharge
NRS Pain Score With Movement POD2
Time frame: 48 hours after surgery
Opioid Consumption Postoperative Day (POD) 1
Time frame: 0-24 hours postoperatively
Opioid Consumption POD2
Time frame: 24-48 hours postoperative
Hospital Length of Stay
Time frame: Average of 3 days
Patient Outcome Questionnaire (painOUT) Least Pain for 0-24 Hours Postoperatively
Time frame: Participants will be followed for the duration of 2 days post operatively in the hospital
Patient Outcome Questionnaire (painOUT) Least Pain for 24-48 Hours Postoperatively
Time frame: 24-48 hours postoperative
Patient Outcome Questionnaire (painOUT) Most Pain for 0-24 Hours Postoperatively
Time frame: 0-24 hours postoperatively
Patient Outcome Questionnaire (painOUT) Most Pain for 24-48 Hours Postoperatively
Time frame: 24-48 hours postoperative
Knee Society Score (KSS) at 6 Weeks Postoperatively
Time frame: Post operatively at approximately 6 weeks after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Enrique A Goytizolo, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine, Morphine and Methylprednisolone in people with Osteoarthritis, run by Hospital for Special Surgery, New York 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 1 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 11 Jan 2019. 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.
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?
Yes. Results are posted in the registry (first posted 11 Jan 2019). 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?
Time to Meet Physical Therapy Discharge Criteria (time frame: First 3 days post-operatively). 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 11 Jan 2019.