Total Knee ArthroplastyPhase 4NCT01797588
Pain After Total Knee Arthroplasty: A Trial Examining Combined Adductor-canal Nerve Block and Periarticular Infiltration Versus Adductor Canal Nerve Block Versus Periarticular Infiltration
A Phase 4 study testing Adductor-canal block and Periarticular infiltration in people with Total Knee Arthroplasty and Postoperative Pain, run by North York General Hospital at 1 site in Canada.
Trial summary
Effective pain management following total knee arthroplasty is important to facilitate early mobilization and rehabilitation. To manage post-operative pain, multimodal analgesia, including acetaminophen, NSAID's, gabapentin, opioids and local anesthetics are used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Postoperative Pain
- What is being tested?
- Adductor-canal block and Periarticular infiltration
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Mar 2014
- 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
- age 18 years or older
- ASA I-III
- eligible for spinal anesthetic
- able to speak
- read and understand English
- willing to participate in the trial
- will be discharged home.
Who cannot join
- contraindication to regional anesthesia
- have an allergy to local anesthetics
- contradiction to NSAID's
- have chronic pain that is not related to their knee joint
- have been using opioids on a chronic basis (3 months or longer)
- have a pre-existing peripheral neuropathy involving the operative site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain After Total Knee Arthroplasty: A Randomized Controlled Trial Examining the Effectiveness of a Combined Adductor-canal Peripheral Nerve Block With Periarticular Infiltration Versus Adductor-canal Nerve Block Alone Versus Periarticular Infiltration Alone.
Effective pain management following total knee arthroplasty is important to facilitate early mobilization and rehabilitation. To manage post-operative pain, multimodal analgesia, including acetaminophen, NSAID's, gabapentin, opioids and local anesthetics are used. However, local anesthetics injected into the femoral nerve area may cause a block in motor function of the quadriceps muscle. Both adductor-canal peripheral nerve block performed pre-operatively, and periarticular infiltration performed intra-operatively are effective in reducing pain following TKA without causing quadriceps motor block which can impede mobilization. No published trials have been found that compare single shot adductor-canal block plus periarticular infiltration to periarticular infiltration only or adductor-canal nerve block only. The purpose of this trial is to examine the effect of 3 different approaches to nerve blockade: 1) adductor-canal block plus periarticular infiltration; 2) adductor-canal block only; 3) periarticular infiltration only, on pain, analgesic consumption, mobility, pain related interference with activities and length of hospital stay in participants undergoing unilateral TKA. Patients will be eligible for participation if they are 18 years old or older, and can speak, and read English. Ninety-six trial participants will be randomized to receive 1 of the 3 approaches to nerve blockade as part of their pain management plan. Outcomes will be measured on post-operative days 1 and 2 and length of stay will be calculated in hours after the participant is discharged to home. It is hypothesized that participants that receive both adductor-canal nerve block plus periarticular infiltration will report less pain, improved mobility and less pain related interference with activities.
Read the detailed description
Hypothesis:
The combination of adductor-canal peripheral nerve block with periarticular intra-operative infiltration (AC+PI) provides superior analgesia and preserves motor function as compared to adductor-canal block (AC) only or periarticular infusion (PI) only.
Specific Aims:
The primary outcome of this trial is to examine pain on walking, using a 0 to 10 numeric rating scale (NRS), at post-operative day 1 in patients who undergo TKA using 3 different approaches to nerve blockade: 1) adductor-canal block plus periarticular infiltration; 2) adductor-canal block only; 3) periarticular infiltration only.
The secondary outcomes of this trial are to examine, in patients who undergo TKA using 3 different approaches to nerve blockade: 1) adductor-canal block plus periarticular infiltration; 2) adductor-canal block only; 3) periarticular infiltration only:
- pain at rest on post-operative day 1 and day 2 at 1000
- pain with walking on post-operative day 2
- pain with knee flexion on post-operative day 1 and day 2 at 1000
- analgesic consumption on post-operative day 1 and day 2
- distance walked on post-operative day 1 and day 2
- pain related interference with activities on post-operative day 1 and day 2
- length of stay
- Conditions
- Total Knee Arthroplasty, Postoperative Pain
- Being tested
- Adductor-canal block, Periarticular infiltration
- Keywords
- Total Knee Arthroplasty, Pain, Periarticular infiltration, Adductor canal block, Postoperative
- Medical subject headings
- Pain, Postoperative, 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
The adductor-canal will be located via ultra sound and a total of 30mL of 0.33% ropivacaine will be injected into the area surrounding the saphenous nerve.
Periarticular infiltrationProcedure or surgery
Periarticular infiltration will be performed intra-operatively and involves administering a 110 mL solution of ropivacaine 300mg, preservative free morphine 10mg, ketorolac 30mg mixed in normal saline into the knee. In each Knee: the first 20mL aliquot is injected into the posterior capsule and the medial and lateral ligaments just prior to implantation; after the implants have been cemented and curing, another 20mL is infiltrated to the quadriceps and retinacular tissues. The remaining solution (~60mL) is used to infiltrate the muscle, subcutaneous tissues.
| Study group | Role | What they receive |
|---|---|---|
| adductor-canal block and periarticular infiltration | Active comparator | Adductor-canal block,performed prior to surgery using ultra sound guidance by an anesthetist, with a total of 30mL of 0.33% ropivacaine injected into the area surrounding the saphenous nerve. Periarticular infiltration, performed intra-operatively by the surgeon, involves administering a 110 mL solution of ropivacaine 300mg, preservative free morphine 10mg, ketorolac 30mg mixed in normal saline into the knee. Receives: Procedure: Adductor-canal block; Procedure: Periarticular infiltration |
| adductor-canal block | Active comparator | The adductor-canal block only group will receive an adductor-canal block prior to surgery in the block room using ultra sound guidance by an anesthetist. After the adductor-canal is located a total of 30mL of 0.33% ropivacaine will be injected into the area surrounding the saphenous nerve. Participants will also receive 110mL of normal saline administered as follows: the first 20mL aliquot is injected into the posterior capsule and the medial and lateral ligaments just prior to implantation; after the implants have been cemented and curing, another 20mL is infiltrated to the quadriceps and retinacular tissues. The remaining solution (~60mL) is used to infiltrate the muscle, subcutaneous tissues. Receives: Procedure: Adductor-canal block |
| periarticular infusion group | Active comparator | Periarticular infiltration,performed intra-operatively,involves administering a 110 mL solution of ropivacaine 300mg, preservative free morphine 10mg, ketorolac 30mg mixed in normal saline into the knee. It will be administered as follows: the first 20mL aliquot is injected into the posterior capsule and the medial and lateral ligaments just prior to implantation; after the implants have been cemented and curing, another 20mL is infiltrated to the quadriceps and retinacular tissues. The remaining solution (~60mL) is used to infiltrate the muscle, subcutaneous tissues. Receives: Procedure: Periarticular infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
The primary outcome of this trial is to examine pain on walking, using a 0 to 10 numeric rating scale (NRS), at post-operative day 1 in patients who undergo TKA
Measured: Post-operative day 1
Secondary outcomes (1)
pain related interference with activities
This will be measured using the BPI-interference subscale.
Measured: on post-operative day 1 and day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- North York General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Sawhney, North York General Hospital
- Investigators
- Monakshi Sawhney, PhD, Principal investigator, North York General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797588
- Sponsor's protocol ID
- NYGHTKA-01
- Status last verified
- Jan 2015
- First submitted
- 20 Feb 2013
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain After Total Knee Arthroplasty: A Randomized Controlled Trial Examining the Effectiveness of a Combined Adductor-canal Peripheral Nerve Block With Periarticular Infiltration Versus Adductor-canal Nerve Block Alone Versus Periarticular Infiltration Alone.
- ClinicalTrials.gov ID
- NCT01797588
- Acronym / sponsor ID
- NYGHTKA-01
- Conditions
- Total Knee Arthroplasty, Postoperative Pain
- Keywords
- Total Knee Arthroplasty, Pain, Periarticular infiltration, Adductor canal block, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- North York General HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Feb 2013 (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.
Effective pain management following total knee arthroplasty is important to facilitate early mobilization and rehabilitation. To manage post-operative pain, multimodal analgesia, including acetaminophen, NSAID's, gabapentin, opioids and local anesthetics are used. However, local anesthetics injected into the femoral nerve area may cause a block in motor function of the quadriceps muscle. Both adductor-canal peripheral nerve block performed pre-operatively, and periarticular infiltration performed intra-operatively are effective in reducing pain following TKA without causing quadriceps motor block which can impede mobilization. No published trials have been found that compare single shot adductor-canal block plus periarticular infiltration to periarticular infiltration only or adductor-canal nerve block only. The purpose of this trial is to examine the effect of 3 different approaches to nerve blockade: 1) adductor-canal block plus periarticular infiltration; 2) adductor-canal block only; 3) periarticular infiltration only, on pain, analgesic consumption, mobility, pain related interference with activities and length of hospital stay in participants undergoing unilateral TKA. Patients will be eligible for participation if they are 18 years old or older, and can speak, and read English. Ninety-six trial participants will be randomized to receive 1 of the 3 approaches to nerve blockade as part of their pain management plan. Outcomes will be measured on post-operative days 1 and 2 and length of stay will be calculated in hours after the participant is discharged to home. It is hypothesized that participants that receive both adductor-canal nerve block plus periarticular infiltration will report less pain, improved mobility and less pain related interference with activities.
Detailed description
Hypothesis:
The combination of adductor-canal peripheral nerve block with periarticular intra-operative infiltration (AC+PI) provides superior analgesia and preserves motor function as compared to adductor-canal block (AC) only or periarticular infusion (PI) only.
Specific Aims:
The primary outcome of this trial is to examine pain on walking, using a 0 to 10 numeric rating scale (NRS), at post-operative day 1 in patients who undergo TKA using 3 different approaches to nerve blockade: 1) adductor-canal block plus periarticular infiltration; 2) adductor-canal block only; 3) periarticular infiltration only.
The secondary outcomes of this trial are to examine, in patients who undergo TKA using 3 different approaches to nerve blockade: 1) adductor-canal block plus periarticular infiltration; 2) adductor-canal block only; 3) periarticular infiltration only:
- pain at rest on post-operative day 1 and day 2 at 1000
- pain with walking on post-operative day 2
- pain with knee flexion on post-operative day 1 and day 2 at 1000
- analgesic consumption on post-operative day 1 and day 2
- distance walked on post-operative day 1 and day 2
- pain related interference with activities on post-operative day 1 and day 2
- length of stay
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| adductor-canal block and periarticular infiltration | Active comparator | Procedure: Adductor-canal block, Procedure: Periarticular infiltrationAdductor-canal block,performed prior to surgery using ultra sound guidance by an anesthetist, with a total of 30mL of 0.33% ropivacaine injected into the area surrounding the saphenous nerve. Periarticular infiltration, performed intra-operatively by the surgeon, involves administering a 110 mL solution of ropivacaine 300mg, preservative free morphine 10mg, ketorolac 30mg mixed in normal saline into the knee. |
| adductor-canal block | Active comparator | Procedure: Adductor-canal blockThe adductor-canal block only group will receive an adductor-canal block prior to surgery in the block room using ultra sound guidance by an anesthetist. After the adductor-canal is located a total of 30mL of 0.33% ropivacaine will be injected into the area surrounding the saphenous nerve. Participants will also receive 110mL of normal saline administered as follows: the first 20mL aliquot is injected into the posterior capsule and the medial and lateral ligaments just prior to implantation; after the implants have been cemented and curing, another 20mL is infiltrated to the quadriceps and retinacular tissues. The remaining solution (~60mL) is used to infiltrate the muscle, subcutaneous tissues. |
| periarticular infusion group | Active comparator | Procedure: Periarticular infiltrationPeriarticular infiltration,performed intra-operatively,involves administering a 110 mL solution of ropivacaine 300mg, preservative free morphine 10mg, ketorolac 30mg mixed in normal saline into the knee. It will be administered as follows: the first 20mL aliquot is injected into the posterior capsule and the medial and lateral ligaments just prior to implantation; after the implants have been cemented and curing, another 20mL is infiltrated to the quadriceps and retinacular tissues. The remaining solution (~60mL) is used to infiltrate the muscle, subcutaneous tissues. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18 years or older
- ASA I-III
- eligible for spinal anesthetic
- able to speak
- read and understand English
Key exclusion criteria (6 listed)
- contraindication to regional anesthesia
- have an allergy to local anesthetics
- contradiction to NSAID's
- have chronic pain that is not related to their knee joint
- have been using opioids on a chronic basis (3 months or longer)
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 blockThe adductor-canal will be located via ultra sound and a total of 30mL of 0.33% ropivacaine will be injected into the area surrounding the saphenous nerve. | Procedure or surgery | adductor-canal block, adductor-canal block and periarticular infiltration |
| Periarticular infiltrationPeriarticular infiltration will be performed intra-operatively and involves administering a 110 mL solution of ropivacaine 300mg, preservative free morphine 10mg, ketorolac 30mg mixed in normal saline into the knee. In each Knee: the first 20mL aliquot is injected into the posterior capsule and the medial and lateral ligaments just prior to implantation; after the implants have been cemented and curing, another 20mL is infiltrated to the quadriceps and retinacular tissues. The remaining solution (~60mL) is used to infiltrate the muscle, subcutaneous tissues. | Procedure or surgery | adductor-canal block and periarticular infiltration, periarticular infusion group |
Primary outcome
Pain Intensity
Time frame: Post-operative day 1
The primary outcome of this trial is to examine pain on walking, using a 0 to 10 numeric rating scale (NRS), at post-operative day 1 in patients who undergo TKA
1 secondary outcome
pain related interference with activities
Time frame: on post-operative day 1 and day 2
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 5 Jan 2015.
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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.
Monakshi Sawhney, PhD principal investigator
North York General 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 and Periarticular infiltration in people with Total Knee Arthroplasty and Postoperative Pain, run by North York General Hospital 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 7 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 5 Jan 2015. 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. 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?
Pain Intensity (time frame: Post-operative day 1). 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 5 Jan 2015.