Total Knee ArthroplastyPhase 4ACB in TKANCT02411149
Adductor Canal Block and Recovery After Total Knee Replacement Surgery
A Phase 4 study testing Adductor Canal Block, Adductor Canal Block with Morphine and Local Infiltration in people with Total Knee Arthroplasty, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study aims to compare the functional recovery of patients undergoing Total Knee Arthroplasty based on the administration of an adductor canal block during their anesthesia treatment Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Adductor Canal Block, Adductor Canal Block with Morphine and Local Infiltration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists Physical Status I-III
- 18 - 80 years of age
- BMI 18 - 40
- Scheduled for elective total knee replacement under spinal anesthesia
- Able to ambulate independently with a standard wheeled walker as maximum mobility aid
Who cannot join
- Revision knee arthroplasty
- Bilateral knee arthroplasty
- Lack of mental ability to provide informed consent
- Neuropathic pain or sensory disorders of the surgical limb
- Contraindication to regional anesthesia (intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of block)
- Chronic opioid use defined as > 30 mg of daily oral morphine equivalents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adductor Canal Block and Functional Recovery After Total Knee Arthroplasty. A Double-Blind, Randomized Controlled Trial
This study aims to compare the functional recovery of patients undergoing Total Knee Arthroplasty based on the administration of an adductor canal block during their anesthesia treatment
Read the detailed description
The period after total knee replacement (TKR) surgery is known to be painful for the first 24 hours, lasting up to 3 days in many cases. Successful management of pain after TKR is regarded as necessary to early recovery, rehabilitation and timely discharge. Severe pain following major joint arthroplasty can hinder early rehabilitation, may result in prolonged hospitalization and is a strong predictor of persistent pain beyond 3 months. Adequate analgesia following TKR is paramount to early recovery, rehabilitation and timely discharge. Therefore early postoperative analgesic and rehabilitation goals are intricately related.
Until now, different methods of pain treatment have been used, including intravenous narcotic pain medication, continuous femoral nerve block (numbing medication to a nerve in the thigh) and epidural analgesia (identical to the numbing method for childbirth). These are all effective methods but each is limited by side effects. In recent years, research has focused on administering local anesthetic further down in the leg, trying to minimize quadriceps muscle weakness while giving adequate pain relief after surgery. Local Infiltration Analgesia (LIA) and Adductor Canal Block (ACB) are examples of new farther sites of administration.
The purpose of this study is to determine which combination of analgesic interventions is the most effective treatment for pain and improvement in functional outcome for TKR.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Adductor Canal Block, Adductor Canal Block with Morphine, Local Infiltration
- Keywords
- Adductor Canal Block, Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal BlockDrug
Also called ropivacaine with epinephrine
Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine.
Adductor Canal Block with MorphineDrug
Also called ropivacaine with epinephrine and spinal intrathecal morphine
Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine and 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml)
Local InfiltrationDrug
Also called saline
30 ml normal saline in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine, in addition to the local infiltration.
| Study group | Role | What they receive |
|---|---|---|
| Local Inflitration Only | Placebo comparator | This group will receive LIA and saline solution (placebo) in the adductor canal block with NO morphine in the spinal anesthesia:
* 30 ml normal saline
* 3ml 0.5% preservative-free bupivacaine Receives: Drug: Local Infiltration |
| Adductor Canal Block | Active comparator | This group will receive LIA and the standard local anesthetic in the ACB with NO morphine in the spinal anesthetic:
* ropivacaine 0.5% with 1:400,000 epinephrine
* 3ml 0.5% preservative-free bupivacaine Receives: Drug: Adductor Canal Block |
| Adductor Canal Block with Morphine | Active comparator | This group will receive LIA with local anesthetic in the ACB and morphine in the spinal anesthetic:
* ropivacaine 0.5% with 1:400,000 epinephrine
* 3ml 0.5% preservative-free bupivacaine with 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml) Receives: Drug: Adductor Canal Block with Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go test
TUG test reflects the time it takes a subject to stand up from a standard height armchair, walk 3 meters, walk back to the chair and sit down. It intends to assess a patient's global mobility as well as balance and risk of falling.
Measured: 2-3 days post srugery
Secondary outcomes (10)
Pain outcome - NRS
- Pain scores assessed with an 11 point verbal numeric rating scale (NRS) where 0 is "no pain" and 10 is "the worst pain imaginable", both at rest and during active physiotherapy (measured daily for 3 days post-operatively) .
Measured: 2-3 days post surgery
Analgesic outcomes - Cumulative systemic opioid consumption
Cumulative systemic opioid consumption measured as oral morphine mg equivalents (daily for 3 days post-operatively).
Measured: 2-3 days post surgery
Analgesic outcomes - Proportion of patients who required "rescue" intravenous patient controlled analgesia
Proportion of patients who required "rescue" intravenous patient controlled analgesia (iv PCA) anytime in the post-operative period.
Measured: 2-3 days post surgery
Analgesic outcomes - Incidence of opioid-related side effects
Incidence of opioid-related side effects
Measured: 2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees
Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees (measured daily for 3 days post-operatively)
Measured: 2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Distance walked
Distance walked
Measured: 2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Hospital length of stay
Hospital length of stay
Measured: 2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Discharge destination
Discharge destination (home or rehabilitation facility)
Measured: 2-3 days post surgery
Medium-term self-reported functional outcome measures - WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively
Measured: baseline and 2-3 days post surgery
Medium-term self-reported functional outcome measures - LEFS
Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively.
Measured: baseline and 2-3 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anahi Perlas, MD, Principal investigator, University of Toronto. University Health Network. Toronto Western Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411149
- Sponsor's protocol ID
- 13-7016-A
- Acronym
- ACB in TKA
- Status last verified
- Nov 2017
- First submitted
- 30 Mar 2015
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Puolakka PA, Rorarius MG, Roviola M, Puolakka TJ, Nordhausen K, Lindgren L. Persistent pain following knee arthroplasty. Eur J Anaesthesiol. 2010 May;27(5):455-60. doi: 10.1097/EJA.0b013e328335b31c.
PubMed 20299989Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
PubMed 10422923Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
PubMed 16651569Biswas A, Perlas A, Ghosh M, Chin K, Niazi A, Pandher B, Chan V. Relative Contributions of Adductor Canal Block and Intrathecal Morphine to Analgesia and Functional Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2018 Feb;43(2):154-160. doi: 10.1097/AAP.0000000000000724.
PubMed 29315129
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block and Functional Recovery After Total Knee Arthroplasty. A Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02411149
- Acronym / sponsor ID
- ACB in TKA / 13-7016-A
- Conditions
- Total Knee Arthroplasty
- Keywords
- Adductor Canal Block, Total Knee Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Apr 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.
This study aims to compare the functional recovery of patients undergoing Total Knee Arthroplasty based on the administration of an adductor canal block during their anesthesia treatment
Detailed description
The period after total knee replacement (TKR) surgery is known to be painful for the first 24 hours, lasting up to 3 days in many cases. Successful management of pain after TKR is regarded as necessary to early recovery, rehabilitation and timely discharge. Severe pain following major joint arthroplasty can hinder early rehabilitation, may result in prolonged hospitalization and is a strong predictor of persistent pain beyond 3 months. Adequate analgesia following TKR is paramount to early recovery, rehabilitation and timely discharge. Therefore early postoperative analgesic and rehabilitation goals are intricately related.
Until now, different methods of pain treatment have been used, including intravenous narcotic pain medication, continuous femoral nerve block (numbing medication to a nerve in the thigh) and epidural analgesia (identical to the numbing method for childbirth). These are all effective methods but each is limited by side effects. In recent years, research has focused on administering local anesthetic further down in the leg, trying to minimize quadriceps muscle weakness while giving adequate pain relief after surgery. Local Infiltration Analgesia (LIA) and Adductor Canal Block (ACB) are examples of new farther sites of administration.
The purpose of this study is to determine which combination of analgesic interventions is the most effective treatment for pain and improvement in functional outcome for TKR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Local Inflitration Only | Placebo comparator | Drug: Local InfiltrationThis group will receive LIA and saline solution (placebo) in the adductor canal block with NO morphine in the spinal anesthesia: * 30 ml normal saline * 3ml 0.5% preservative-free bupivacaine |
| Adductor Canal Block | Active comparator | Drug: Adductor Canal BlockThis group will receive LIA and the standard local anesthetic in the ACB with NO morphine in the spinal anesthetic: * ropivacaine 0.5% with 1:400,000 epinephrine * 3ml 0.5% preservative-free bupivacaine |
| Adductor Canal Block with Morphine | Active comparator | Drug: Adductor Canal Block with MorphineThis group will receive LIA with local anesthetic in the ACB and morphine in the spinal anesthetic: * ropivacaine 0.5% with 1:400,000 epinephrine * 3ml 0.5% preservative-free bupivacaine with 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- American Society of Anesthesiologists Physical Status I-III
- 18 - 80 years of age
- BMI 18 - 40
- Scheduled for elective total knee replacement under spinal anesthesia
- Able to ambulate independently with a standard wheeled walker as maximum mobility aid
Key exclusion criteria (6 listed)
- Revision knee arthroplasty
- Bilateral knee arthroplasty
- Lack of mental ability to provide informed consent
- Neuropathic pain or sensory disorders of the surgical limb
- Contraindication to regional anesthesia (intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of block)
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 BlockAlso: ropivacaine with epinephrineUse of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine. | Drug | Adductor Canal Block |
| Adductor Canal Block with MorphineAlso: ropivacaine with epinephrine and spinal intrathecal morphineUse of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine and 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml) | Drug | Adductor Canal Block with Morphine |
| Local InfiltrationAlso: saline30 ml normal saline in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine, in addition to the local infiltration. | Drug | Local Inflitration Only |
Primary outcome
Timed Up and Go test
Time frame: 2-3 days post srugery
TUG test reflects the time it takes a subject to stand up from a standard height armchair, walk 3 meters, walk back to the chair and sit down. It intends to assess a patient's global mobility as well as balance and risk of falling.
10 secondary outcomes
Pain outcome - NRS
Time frame: 2-3 days post surgery
Analgesic outcomes - Cumulative systemic opioid consumption
Time frame: 2-3 days post surgery
Analgesic outcomes - Proportion of patients who required "rescue" intravenous patient controlled analgesia
Time frame: 2-3 days post surgery
Analgesic outcomes - Incidence of opioid-related side effects
Time frame: 2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees
Time frame: 2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Distance walked
Time frame: 2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Hospital length of stay
Time frame: 2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Discharge destination
Time frame: 2-3 days post surgery
Medium-term self-reported functional outcome measures - WOMAC
Time frame: baseline and 2-3 days post surgery
Medium-term self-reported functional outcome measures - LEFS
Time frame: baseline and 2-3 days post surgery
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 24 Nov 2017.
- Background: PubMed 20299989Puolakka PA, Rorarius MG, Roviola M, Puolakka TJ, Nordhausen K, Lindgren L. Persistent pain following knee arthroplasty. Eur J Anaesthesiol. 2010 May;27(5):455-60. doi: 10.1097/EJA.0b013e328335b31c.
- Background: PubMed 10422923Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
- Background: PubMed 16651569Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
- Derived from this study: PubMed 29315129Biswas A, Perlas A, Ghosh M, Chin K, Niazi A, Pandher B, Chan V. Relative Contributions of Adductor Canal Block and Intrathecal Morphine to Analgesia and Functional Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2018 Feb;43(2):154-160. doi: 10.1097/AAP.0000000000000724.
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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.
Anahi Perlas, MD principal investigator
University of Toronto. University Health Network. Toronto Western Hospital.
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 Adductor Canal Block, Adductor Canal Block with Morphine and Local Infiltration in people with Total Knee Arthroplasty, run by University Health Network, Toronto at 1 site in Canada.
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 6 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 24 Nov 2017. 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 Canada. 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?
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?
Timed Up and Go test (time frame: 2-3 days post srugery). 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 NCT02411149, which also lists 4 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 24 Nov 2017.