Acute PainPhase 4NCT02603900
Adductor Canal Catheter vs Local Infiltration of Analgesia for Total Knee Arthroplasty
A Phase 4 study testing ropivacaine, bupivacaine and Adductor Canal Catheter in people with Acute Pain and Regional Anesthesia Morbidity, run by Thomas Jefferson University at 1 site in United States.
Trial summary
The study is a prospective randomized controlled trial comparing local infiltration of analgesia in the knee joint and adductor canal catheters for postoperative analgesia following a primary Total Knee Arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Acute Pain, Regional Anesthesia Morbidity
- What is being tested?
- ropivacaine, bupivacaine and Adductor Canal Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2016
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-85
- American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. • Undergoing Unilateral, Primary, Total Knee Arthroplasty
- English as native language
Who cannot join
- Patient refusal
- History of opioid dependence
- Contraindication to peripheral nerve block • Pre-existing significant neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Double-Blinded Randomized Controlled Trial Comparing the Adductor Canal Catheter (ACC) and Local Infiltration of Analgesia (LIA) Following Primary Total Knee Arthroplasty
The study is a prospective randomized controlled trial comparing local infiltration of analgesia in the knee joint and adductor canal catheters for postoperative analgesia following a primary Total Knee Arthroplasty (TKA).
Read the detailed description
The study is a prospective, randomized controlled clinical trial comparing two methods of postoperative analgesia following primary TKA. Eligible primary TKA patients must be ASA I - III and require less than 20 mg oxycodone daily (or its equivalent). Exclusion criteria are: allergy to anesthetics, contraindication to regional anesthesia, sensory/ motor disorder involving operative limb, non-english speaking, ASA IV or greater, psychiatric or cognitive disorders, incarceration, renal insufficiency with Cr > 2.0 and hepatic failure. When patients agree to participate in the study the following data will be collected by the research staff: ASA physical status, age, height, weight, gender, quantitative opiate use, numeric pain score with visual descriptors, painDETECT score, WOMAC score and baseline Pain Management Questionnaire. When designated through randomization, local infiltration of analgesia will be placed intraoperatively by the surgeons, per usual protocol and patients in the LIA group will receive sham adductor canal catheter. All ACC's for both study groups will be placed postoperatively in the PACU. Those collecting data will be blinded from identifying patients in the control group, as both groups will have ACC placed with same technique. Potential risks for each procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity in the form of seizure and cardiac arrest and neuropathy. The preceding are commonly listed though infrequent complications of both procedures. Continuous ultrasound will guide the placement of the ACC. All adductor canal catheters will remain in for 72 hours. Pt from LIA group will be discharged home with sham catheter with a saline infusion at 10 ml/hr via an ambulatory pump. Patients in ACC group will be discharged with continuous adductor canal catheter delivering ropivacaine 0.2% at 10 ml/hr via an ambulatory pump. Patients will be called daily for pain diary results. As well as at 6-8 weeks postoperatively to collect painDetect and WOMAC survey.
- Conditions
- Acute Pain, Regional Anesthesia Morbidity
- Being tested
- ropivacaine, bupivacaine, Sham Adductor Canal Catheter, Adductor Canal Catheter
- Keywords
- Adductor Canal Catheter, Arthroplasty, Replacement, Knee, Local infiltration of analgesia
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
Also called Naropin
15 ml 0.5% Ropivicaine for primary adductor canal block under ultrasound guidance and 0.2% Ropivicaine infusion 10 ml/hr.
bupivacaineDrug
Also called Marcaine
20 ml bupivacaine ( Marcaine 0.25% with epinephrine 1:200000, Hospira Inc. Lake Forest, IL) diluted with 40 ml of normal saline injected intraoperatively into the knee joint before closure.
Sham Adductor Canal CatheterDevice
Sham catheter placement via ultrasound-guided adductor canal block and 10ml/hr saline via OnQ Pump via continuous catheter in adductor canal.
Adductor Canal CatheterDevice
Catheter placed in adductor canal via ultrasound guidance and continuous infusion via OnQ pump.
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Catheter | Experimental | This group will receive ropivacaine 0.5% 15 ml for the adductor canal block under ultrasound guided nerve block. A multi-orifice catheter will be placed in the adductor canal and an infusion of ropivacaine 0.2% at 10 ml/hr will be continued for 72 hours. Receives: Drug: ropivacaine; Device: Adductor Canal Catheter |
| Local Infiltration of Analgesia | Experimental | Local infiltration using 20 ml of free bupivacaine solution (Marcaine 0.25% with epinephrine 1:200000, ) diluted with 40 ml of normal saline following implantation of the knee prosthesis, the solution will be injected into the vastus medialis (5 ml), medial retinaculum (5 ml), origin of MCL (5 ml) and LCL (5 ml), lateral portion of quadriceps tendon (5 ml), vastus lateralis (5 ml), and subcutaneous tissues especially along saphenous nerve distribution (30 ml). Postoperatively, a sham adductor canal catheter will be placed as in the ACC arm following stabilization in the PACU to infuse only normal saline with an initial bolus of 15 ml saline and infusion of saline at 10ml/hr for 72 hours. Receives: Drug: bupivacaine; Device: Sham Adductor Canal Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain via numeric rating scale at rest and with activity during each physical therapy session
postoperative pain as measured by numeric rating scale at rest and with movement during each physical therapy session.
Measured: post-operative day #0 to post-operative day #3
Secondary outcomes (3)
Postoperative opioid consumption
Opioid consumption during hospitalization in oxycodone equivalents at 24, 48 and 72 hours
Measured: post-operative day #0 to postoperative day # 3
Chronic post-surgical pain measured via validated painDetect and WOMAC questionnaires
Assess post-surgical pain and function as measured by PainDetect and WOMAC questionnaires at 6-8 weeks post-operative compared to preoperative pain and function
Measured: 6-8 weeks after surgical date
Passive and Active Range of Motion during Physical Therapy
Assess quantitative passive and active range of motion during physical therapy as well as Timed up to Go (TUG) which is routine assessment during physical therapy.
Measured: POD #0 to postoperative day #2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Baratta, Thomas Jefferson University
- Investigators
- Jaime L Baratta, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603900
- Sponsor's protocol ID
- 15D.490
- Status last verified
- Dec 2021
- First submitted
- 22 Oct 2015
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.
PubMed 18627367Essving P, Axelsson K, Aberg E, Spannar H, Gupta A, Lundin A. Local infiltration analgesia versus intrathecal morphine for postoperative pain management after total knee arthroplasty: a randomized controlled trial. Anesth Analg. 2011 Oct;113(4):926-33. doi: 10.1213/ANE.0b013e3182288deb. Epub 2011 Aug 4.
PubMed 21821506Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.
PubMed 21394001Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
PubMed 22221014Kazak Bengisun Z, Aysu Salviz E, Darcin K, Suer H, Ates Y. Intraarticular levobupivacaine or bupivacaine administration decreases pain scores and provides a better recovery after total knee arthroplasty. J Anesth. 2010 Oct;24(5):694-9. doi: 10.1007/s00540-010-0970-x. Epub 2010 Jun 23.
PubMed 20571832
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blinded Randomized Controlled Trial Comparing the Adductor Canal Catheter (ACC) and Local Infiltration of Analgesia (LIA) Following Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02603900
- Acronym / sponsor ID
- 15D.490
- Conditions
- Acute Pain, Regional Anesthesia Morbidity
- Keywords
- Adductor Canal Catheter, Arthroplasty, Replacement, Knee, Local infiltration of analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Nov 2015 (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.
The study is a prospective randomized controlled trial comparing local infiltration of analgesia in the knee joint and adductor canal catheters for postoperative analgesia following a primary Total Knee Arthroplasty (TKA).
Detailed description
The study is a prospective, randomized controlled clinical trial comparing two methods of postoperative analgesia following primary TKA. Eligible primary TKA patients must be ASA I - III and require less than 20 mg oxycodone daily (or its equivalent). Exclusion criteria are: allergy to anesthetics, contraindication to regional anesthesia, sensory/ motor disorder involving operative limb, non-english speaking, ASA IV or greater, psychiatric or cognitive disorders, incarceration, renal insufficiency with Cr > 2.0 and hepatic failure. When patients agree to participate in the study the following data will be collected by the research staff: ASA physical status, age, height, weight, gender, quantitative opiate use, numeric pain score with visual descriptors, painDETECT score, WOMAC score and baseline Pain Management Questionnaire. When designated through randomization, local infiltration of analgesia will be placed intraoperatively by the surgeons, per usual protocol and patients in the LIA group will receive sham adductor canal catheter. All ACC's for both study groups will be placed postoperatively in the PACU. Those collecting data will be blinded from identifying patients in the control group, as both groups will have ACC placed with same technique. Potential risks for each procedure, which will be explained to the patient, include: bleeding, local infection, local anesthetic toxicity in the form of seizure and cardiac arrest and neuropathy. The preceding are commonly listed though infrequent complications of both procedures. Continuous ultrasound will guide the placement of the ACC. All adductor canal catheters will remain in for 72 hours. Pt from LIA group will be discharged home with sham catheter with a saline infusion at 10 ml/hr via an ambulatory pump. Patients in ACC group will be discharged with continuous adductor canal catheter delivering ropivacaine 0.2% at 10 ml/hr via an ambulatory pump. Patients will be called daily for pain diary results. As well as at 6-8 weeks postoperatively to collect painDetect and WOMAC survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Catheter | Experimental | Drug: ropivacaine, Device: Adductor Canal CatheterThis group will receive ropivacaine 0.5% 15 ml for the adductor canal block under ultrasound guided nerve block. A multi-orifice catheter will be placed in the adductor canal and an infusion of ropivacaine 0.2% at 10 ml/hr will be continued for 72 hours. |
| Local Infiltration of Analgesia | Experimental | Drug: bupivacaine, Device: Sham Adductor Canal CatheterLocal infiltration using 20 ml of free bupivacaine solution (Marcaine 0.25% with epinephrine 1:200000, ) diluted with 40 ml of normal saline following implantation of the knee prosthesis, the solution will be injected into the vastus medialis (5 ml), medial retinaculum (5 ml), origin of MCL (5 ml) and LCL (5 ml), lateral portion of quadriceps tendon (5 ml), vastus lateralis (5 ml), and subcutaneous tissues especially along saphenous nerve distribution (30 ml). Postoperatively, a sham adductor canal catheter will be placed as in the ACC arm following stabilization in the PACU to infuse only normal saline with an initial bolus of 15 ml saline and infusion of saline at 10ml/hr for 72 hours. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 40-85
- American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. • Undergoing Unilateral, Primary, Total Knee Arthroplasty
- English as native language
Key exclusion criteria (3 listed)
- Patient refusal
- History of opioid dependence
- Contraindication to peripheral nerve block • Pre-existing significant neuropathy
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: Naropin15 ml 0.5% Ropivicaine for primary adductor canal block under ultrasound guidance and 0.2% Ropivicaine infusion 10 ml/hr. | Drug | Adductor Canal Catheter |
| bupivacaineAlso: Marcaine20 ml bupivacaine ( Marcaine 0.25% with epinephrine 1:200000, Hospira Inc. Lake Forest, IL) diluted with 40 ml of normal saline injected intraoperatively into the knee joint before closure. | Drug | Local Infiltration of Analgesia |
| Sham Adductor Canal CatheterSham catheter placement via ultrasound-guided adductor canal block and 10ml/hr saline via OnQ Pump via continuous catheter in adductor canal. | Device | Local Infiltration of Analgesia |
| Adductor Canal CatheterCatheter placed in adductor canal via ultrasound guidance and continuous infusion via OnQ pump. | Device | Adductor Canal Catheter |
Primary outcome
Post-operative pain via numeric rating scale at rest and with activity during each physical therapy session
Time frame: post-operative day #0 to post-operative day #3
postoperative pain as measured by numeric rating scale at rest and with movement during each physical therapy session.
3 secondary outcomes
Postoperative opioid consumption
Time frame: post-operative day #0 to postoperative day # 3
Chronic post-surgical pain measured via validated painDetect and WOMAC questionnaires
Time frame: 6-8 weeks after surgical date
Passive and Active Range of Motion during Physical Therapy
Time frame: POD #0 to postoperative day #2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Background: PubMed 18627367Fischer HB, Simanski CJ, Sharp C, Bonnet F, Camu F, Neugebauer EA, Rawal N, Joshi GP, Schug SA, Kehlet H; PROSPECT Working Group. A procedure-specific systematic review and consensus recommendations for postoperative analgesia following total knee arthroplasty. Anaesthesia. 2008 Oct;63(10):1105-23. doi: 10.1111/j.1365-2044.2008.05565.x. Epub 2008 Jul 10.
- Background: PubMed 21821506Essving P, Axelsson K, Aberg E, Spannar H, Gupta A, Lundin A. Local infiltration analgesia versus intrathecal morphine for postoperative pain management after total knee arthroplasty: a randomized controlled trial. Anesth Analg. 2011 Oct;113(4):926-33. doi: 10.1213/ANE.0b013e3182288deb. Epub 2011 Aug 4.
- Background: PubMed 21394001Charous MT, Madison SJ, Suresh PJ, Sandhu NS, Loland VJ, Mariano ER, Donohue MC, Dutton PH, Ferguson EJ, Ilfeld BM. Continuous femoral nerve blocks: varying local anesthetic delivery method (bolus versus basal) to minimize quadriceps motor block while maintaining sensory block. Anesthesiology. 2011 Oct;115(4):774-81. doi: 10.1097/ALN.0b013e3182124dc6.
- Background: PubMed 22221014Jenstrup MT, Jaeger P, Lund J, Fomsgaard JS, Bache S, Mathiesen O, Larsen TK, Dahl JB. Effects of adductor-canal-blockade on pain and ambulation after total knee arthroplasty: a randomized study. Acta Anaesthesiol Scand. 2012 Mar;56(3):357-64. doi: 10.1111/j.1399-6576.2011.02621.x. Epub 2012 Jan 4.
- Background: PubMed 20571832Kazak Bengisun Z, Aysu Salviz E, Darcin K, Suer H, Ates Y. Intraarticular levobupivacaine or bupivacaine administration decreases pain scores and provides a better recovery after total knee arthroplasty. J Anesth. 2010 Oct;24(5):694-9. doi: 10.1007/s00540-010-0970-x. Epub 2010 Jun 23.
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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.
Jaime L Baratta, MD principal investigator
Thomas Jefferson University
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 ropivacaine, bupivacaine and Adductor Canal Catheter in people with Acute Pain and Regional Anesthesia Morbidity, run by Thomas Jefferson University 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 3 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: withdrawn, as of the sponsor's last update on 15 Dec 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 via numeric rating scale at rest and with activity during each physical therapy session (time frame: post-operative day #0 to post-operative day #3). 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 NCT02603900, which also lists 5 linked publications.
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 15 Dec 2021.