Arthroplasty, Replacement, KneeNCT03038425
Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?
A study testing Normal Saline and Ropivacaine in people with Arthroplasty, Replacement, Knee and Nerve Block, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This is a randomized, double-blinded pilot study to determine whether patients undergoing ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal approach to postoperative analgesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Nerve Block, Anesthesia, Regional
- What is being tested?
- Normal Saline and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteCanada
- Study dates
- 2 May 2017to 1 Apr 2020
- Phase
- Interventional
- 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
- patient characteristics suitable for subvastus approach as determined by single surgeon
- patients willing to undergo ambulatory surgery
- ability to read and verbally communicate via either English or French
Who cannot join
- age > 80
- driving distance greater than 1 hour from hospital
- no willing caregiver at home on night of surgery
- renal failure requiring dialysis
- Insulin-dependent diabetes mellitus
- BMI > 45
Show all 11Show fewer
- allergy to study medications
- pre-existing neurologic deficit involving the ipsilateral limb
- chronic high dose opioid use (defined as >200mg/day of morphine equivalent for over 2 weeks).
- inability to use or manage cACB catheter and pump independently at home
- inability or refusal to cryocompressive therapy device.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized, double-blinded pilot study to determine whether patients undergoing ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal approach to postoperative analgesia. Outcomes include the 15-item Quality of Recovery Scale (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days, functional outcome as measured by the Time Up and Go (TUG) test, patient satisfaction, patient's rating of catheter effectiveness, and complications.
- Conditions
- Arthroplasty, Replacement, Knee, Nerve Block, Anesthesia, Regional, Ambulatory Surgical Procedures
- Being tested
- Normal Saline, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal SalineDrug
This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect
RopivacaineDrug
This is the treatment intervention - ropivacaine 0.2% infused in the adductor canal via a catheter. This will provide analgesia to the knee after TKA
| Study group | Role | What they receive |
|---|---|---|
| Saline infusion | Placebo comparator | Participants in this group will receive normal saline infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours Receives: Drug: Normal Saline |
| Ropivacaine infusion | Active comparator | Participants in this group will receive ropivacaine 0.2% infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery Scale 15 (QoR-15)
QoR-15 is a validated scale calculated from a 15-question patient questionnaire. It is an aggregate score that evaluates recovery after surgery.
Measured: at 4pm on post-operative day (POD) 1
Secondary outcomes (10)
Quality of Recovery Scale 15 (QoR-15)
Measured: POD 2-4 + 7
Pain score at rest
Patients will rate their pain on a scale of 0-10
Measured: POD 1-4 + 7
Pain score with activity
Patients will rate their pain on a scale of 0-10
Measured: POD 1-4 + 7
Tapentadol consumption
Daily tapentadol use in milligrams
Measured: POD 1-4 + 7
Patient satisfaction
Patients will be asked "are you satisfied with your pain control"
Measured: POD 1-4 + 7
Vital signs - blood pressure, heart rate, oxygen saturation
These measurements will be obtained via post-operative home monitoring system
Measured: twice daily POD 1-4
Patient-rated catheter effectiveness
Patients will be asked "do you think the nerve block catheter is helpful? Rate on a 5-point scale"
Measured: POD 1-4
Catheter specific complications
Patients will be asked daily to report these potential nerve block catheter related issues: (1) leakage around the dressing (2) occlusion/blockage of the pump (3) inadvertent catheter disconnection (4) swelling around the catheter site (5) bleeding or bruising around the catheter site (6) other complications
Measured: POD 1-4
Peri-operative complications
Significant peri-operative complications resulting in return to emergency department, re-admission after discharge, or return to operating room will be reported
Measured: POD 30
Timed-up-and-go (TUG) test
TUG is a validated test to assess a person's mobility. It has been used to evaluate functional recovery after orthopedic surgeries. This will be administered on POD 14 at the surgeon's office during the post-operative follow-up visit
Measured: POD 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start2 May 2017
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Responsible party
- Sponsor
- Investigators
- Patrick BY Wong, MD, Principal investigator, The Ottawa Hospital, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038425
- Sponsor's protocol ID
- 20160937
- Status last verified
- Dec 2020
- First submitted
- 20 Jan 2017
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?
- ClinicalTrials.gov ID
- NCT03038425
- Acronym / sponsor ID
- 20160937
- Conditions
- Arthroplasty, Replacement, Knee, Nerve Block, Anesthesia, Regional, Ambulatory Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital Academic Medical Association
- Study start
- 2 May 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 31 Jan 2017 (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 is a randomized, double-blinded pilot study to determine whether patients undergoing ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal approach to postoperative analgesia. Outcomes include the 15-item Quality of Recovery Scale (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days, functional outcome as measured by the Time Up and Go (TUG) test, patient satisfaction, patient's rating of catheter effectiveness, and complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline infusion | Placebo comparator | Drug: Normal SalineParticipants in this group will receive normal saline infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours |
| Ropivacaine infusion | Active comparator | Drug: RopivacaineParticipants in this group will receive ropivacaine 0.2% infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient characteristics suitable for subvastus approach as determined by single surgeon
- patients willing to undergo ambulatory surgery
- ability to read and verbally communicate via either English or French
Key exclusion criteria (11 listed)
- age > 80
- driving distance greater than 1 hour from hospital
- no willing caregiver at home on night of surgery
- renal failure requiring dialysis
- Insulin-dependent diabetes mellitus
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 |
|---|---|---|
| Normal SalineThis is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect | Drug | Saline infusion |
| RopivacaineThis is the treatment intervention - ropivacaine 0.2% infused in the adductor canal via a catheter. This will provide analgesia to the knee after TKA | Drug | Ropivacaine infusion |
Primary outcome
Quality of Recovery Scale 15 (QoR-15)
Time frame: at 4pm on post-operative day (POD) 1
QoR-15 is a validated scale calculated from a 15-question patient questionnaire. It is an aggregate score that evaluates recovery after surgery.
10 secondary outcomes
Quality of Recovery Scale 15 (QoR-15)
Time frame: POD 2-4 + 7
Pain score at rest
Time frame: POD 1-4 + 7
Pain score with activity
Time frame: POD 1-4 + 7
Tapentadol consumption
Time frame: POD 1-4 + 7
Patient satisfaction
Time frame: POD 1-4 + 7
Vital signs - blood pressure, heart rate, oxygen saturation
Time frame: twice daily POD 1-4
Patient-rated catheter effectiveness
Time frame: POD 1-4
Catheter specific complications
Time frame: POD 1-4
Peri-operative complications
Time frame: POD 30
Timed-up-and-go (TUG) test
Time frame: POD 14
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 22 Dec 2020.
- 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.
Patrick BY Wong, MD principal investigator
The Ottawa Hospital, University of Ottawa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Saline and Ropivacaine in people with Arthroplasty, Replacement, Knee and Nerve Block, run by Ottawa Hospital Research Institute 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 3 inclusion and 11 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 22 Dec 2020. 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.
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?
Quality of Recovery Scale 15 (QoR-15) (time frame: at 4pm on post-operative day (POD) 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 22 Dec 2020.