Osteoarthritis, KneeNCT02680392

Functional Outcome and Analgesia in TKA: Radiofrequency vs Continuous Adductor Canal Block

A study testing Pulsed and Continuous Radiofrequency and Continuous Adductor Canal Block in people with Osteoarthritis, Knee, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This randomized, double blind controlled trial is designed to investigate the potential benefits of radiofrequency in terms of analgesia and functional outcome, compared to the conventional continuous adductor canal block, for patients undergoing total knee arthroplasty for osteoarthritis. Read more about this study

Who is it for?: Ages 45 to 80 years
Conditions the study is for: Osteoarthritis, Knee
What is being tested?: Pulsed and Continuous Radiofrequency and Continuous Adductor Canal Block
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteCanada
Study dates: 14 Sep 2015to 7 Jul 2017
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 45 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of knee Osteoarthritis requiring Total Knee Arthroplasty (TKA)

Who cannot join

Previous TKA (revision surgery)
ASA (American Society of Anesthesiology) Classification > 3
Known Rheumatologic disease
Morbid Obesity (BMI > 45)
Inability to perform simple physical tasks (6 minutes walk test, Timed-Up and Go test)
Organ transplant, Allergy to opioids, to local anesthetics or other medications used in the study,
Chronic use of opioids or sedatives, Contraindication to receive regional anesthesia (e.g. coagulation defect), contraindication to Patient Controlled Analgesia pump (PCA) or inability to use PCA or to comprehend pain scales

Trial locations and contacts

1 site in 1 country.

Canada1 site

McGill University Health Centre, Montreal General Hospital
Montreal, Quebec, H3G1A4

Other trials in Canada

About this study

Official title: Functional Outcome and Postoperative Analgesia in Total Knee Arthroplasty: a Comparison Between Continuous Adductor Canal Block and Pulsed and Thermal Radiofrequency of Saphenous and Genicular Nerves of the Knee

Read the detailed description

The aim of this study is to compare the efficacy of two analgesia techniques in patients undergoing Total Knee Arthroplasty (TKA) on the functional recovery and pain control: Pulsed and Continuous Radiofrequency (PRF and TRF) applied respectively to the saphenous nerve and to the genicular nerves of the knee (femoral and sciatic branches) compared with Continuous adductor canal block with local anesthetics (CACB).

The Null Hypothesis is that no difference exists in the functional recovery, in pain medication consumption and in postoperative exercise and physical performance between two groups of patients submitted to TKA with the two different modalities of analgesia.

To test the null hypothesis we hypothesize as clinically relevant:

a reduction of 30% in the time needed to perform the Timed Up and Go test at 2 days after surgery
a reduction of 30% in pain medication consumption in the first 24 ore after surgery.

To test the null Hypothesis, 40 patients are needed (20 for each group).

The primary outcome measures will be:

the time required in the two groups (CACB-group and RF-group) to perform the Timed-Up and Go (TUG) test on the second postoperative day (POD2). TUG measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to use any mobility aids that they would normally require.
the total morphine consumption by means of the patient-controlled analgesia pump over the first 24-h after surgery, which can be measured precisely through the record of the dose delivered by the PCA pump. With an alpha error of 0.05, a power of 80% and a standard deviation of 7 mg of morphine consumption per 24 h, 20 patients (10 in each group) will be required for the study to detect a mean difference of 10 mg of morphine between the two groups

Secondary outcome measures include: Pain evaluation with the use of VAS at rest, VAS on walking and on knee flexion; functional outcome evaluation with the 6 min walk tests, degree of knee flexion, Scores obtained in self-assessment questionaire (WOMAC-Western Ontario and McMaster University questionaire for knee osteoarthritis and CHAMPS-Community Healthy Activities Model Program for Seniors). These values will be compared with baseline values recorded before surgery.

It is hypothesized that PRF and TRF of the saphenous nerve and genicular nerves to the knee joint can improve the early and late functional recovery and the pain control after TKA when compared with the CACB

Conditions: Osteoarthritis, Knee
Being tested: Pulsed and Continuous Radiofrequency, Continuous Adductor Canal Block
Keywords: Pulsed and Continuous Radiofrequency Treatment, Continuous adductor canal block, Postoperative pain, Functional recovery, Total Knee Joint Replacement
Medical subject headings: Osteoarthritis, Knee, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pulsed and Continuous RadiofrequencyProcedure or surgery
Also called PRF
Preoperative pulsed radiofrequency of the saphenous nerve and Continuous radiofrequency of the genicular nerves of the knee joint.
The saphenous nerve will be approached at the adductor canal and it will be treated with Pulsed RF for 4 minutes at 42 Celsius degrees. Ropivacaine 0.5% 10ml with Dexamethasone 10mg will be injected after the RF.
The Genicular terminal branches of the sciatic and femoral nerves will be treated with Continuous RF for 3 min at 80 Celsius degrees and then with 2 ml of Ropivacaine 0.5% and 10 mg of Methylprednisolone to each nerve (5 in total) A sham catheter in the mid-thigh will be placed for patients in the RF group, infusing Normal Saline 0.9% and simulating a Continuous Adductor Canal Block. To blind the investigator to the type of treatment for the postoperative assessment , every solution bag will be prepared by the Pharmacy of the Hospital, covered with a plastic envelope and labeled as "Study Solution".
Continuous Adductor Canal BlockDrug
Also called CACB
The patients in the Adductor canal group, will have a catheter for peripheral nerve block inserted under strict asepsis in the adductor canal under ultrasound guidance, and will receive for postoperative analgesia a 48-h continuous infusion of Ropivacaine 0.2% at 8 ml/hour The patients will receive, intraoperatively 10 mg of Dexamethasone i.v.
To blind the investigator who will do the postoperative assessment to the type of treatment, every solution bag will be prepared by the Pharmacy of the Hospital, covered with a plastic envelope and labeled as "Study Solution". It will be always possible to crack the code and find out to which group the patient belongs

Study groups in NCT02680392
Study group	Role	What they receive
Pulsed and Continuous Radiofrequency	Experimental	In this group of patients undergoing total knee arthroplasty (allocation of patients is randomized), Pulsed radiofrequency (PRF) is applied to the saphenous nerve of the knee, associated to Continuous Radiofrequency (TRF) applied to the genicular nerves of the knee . A sham catheter is inserted in the mid-tigh to simulate a continuous adductor canal block, and connected to an infusion of normal saline (assessor and patient blinded to the treatment) Receives: Procedure: Pulsed and Continuous Radiofrequency
Continuous adductor canal block	Active comparator	Continuous Adductor Canal Block Continuous adductor canal block is performed in this group of patients, with a catheter infusing ropivacaine 0.2% in the first 48 hours after surgery. The solutions bags are labelled in order to make assessor and patients, blinded to the treatment (Ropivacaine vs Normal Saline) Receives: Drug: Continuous Adductor Canal Block

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative morphine consumption
Measured: first postoperative day (first 24 hours)

Secondary outcomes (9)

Timed-Up and Go Test
TUG measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to use any mobility aids that they would normally require
Measured: 2nd postoperative day
Six minutes walk test
This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes
Measured: 6 weeks after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items);Stiffness (2 items); Physical Function (17 items).
The Extent of pain, stiffness in the knee, and physical function related to the disability due to the knee osteoarthritis are assessed with the WOMAC index, before and 6 weeks after surgery (Western-Ontario-McMaster-Universities-Osteoarthritis-Index).
Measured: 6 weeks after surgery
Visual Analogue Scale (VAS) for pain at rest
Measured: 6 weeks after surgery
Visual Analogue Scale (VAS) for pain at movement
Measured: 6 weeks after surgery
Pain medication consumption
Measured: 6 weeks after surgery
Visual Analogue Scale (VAS) for pain at rest
Measured: first 24 hours after surgery
Visual Analogue Scale (VAS) for pain at movement
Measured: First 24 hours after surgery
CHAMPS (Community Healthy Activities Model Program for Seniors) questionnaire
Measured: 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.

14 Sep 20157 Jul 2017

First posted11 Feb 2016 (estimated)
Study start14 Sep 2015
Primary completion2 Jun 2017
Study completion7 Jul 2017

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 Osteoarthritis, KneeStudies of the same condition, open and under way.
More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02680392
Sponsor's protocol ID: 15-209-MUHC
Status last verified: Sep 2021
First submitted: 19 Jan 2016
Last updated: 1 Oct 2021
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Patterson ME, Bland KS, Thomas LC, Elliott CE, Soberon JR Jr, Nossaman BD, Osteen K. The adductor canal block provides effective analgesia similar to a femoral nerve block in patients undergoing total knee arthroplasty--a retrospective study. J Clin Anesth. 2015 Feb;27(1):39-44. doi: 10.1016/j.jclinane.2014.08.005. Epub 2014 Nov 22.
PubMed 25468584
Machi AT, Sztain JF, Kormylo NJ, Madison SJ, Abramson WB, Monahan AM, Khatibi B, Ball ST, Gonzales FB, Sessler DI, Mascha EJ, You J, Nakanote KA, Ilfeld BM. Discharge Readiness after Tricompartment Knee Arthroplasty: Adductor Canal versus Femoral Continuous Nerve Blocks-A Dual-center, Randomized Trial. Anesthesiology. 2015 Aug;123(2):444-56. doi: 10.1097/ALN.0000000000000741.
PubMed 26079800
Carli F, Clemente A, Asenjo JF, Kim DJ, Mistraletti G, Gomarasca M, Morabito A, Tanzer M. Analgesia and functional outcome after total knee arthroplasty: periarticular infiltration vs continuous femoral nerve block. Br J Anaesth. 2010 Aug;105(2):185-95. doi: 10.1093/bja/aeq112. Epub 2010 Jun 14.
PubMed 20551021
Shah NA, Jain NP. Is continuous adductor canal block better than continuous femoral nerve block after total knee arthroplasty? Effect on ambulation ability, early functional recovery and pain control: a randomized controlled trial. J Arthroplasty. 2014 Nov;29(11):2224-9. doi: 10.1016/j.arth.2014.06.010. Epub 2014 Jun 19.
PubMed 25041873
Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
PubMed 24121608

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis, Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Functional Outcome and Postoperative Analgesia in Total Knee Arthroplasty: a Comparison Between Continuous Adductor Canal Block and Pulsed and Thermal Radiofrequency of Saphenous and Genicular Nerves of the Knee
ClinicalTrials.gov ID: NCT02680392
Acronym / sponsor ID: 15-209-MUHC
Conditions: Osteoarthritis, Knee
Keywords: Pulsed and Continuous Radiofrequency Treatment, Continuous adductor canal block, Postoperative pain, Functional recovery, Total Knee Joint Replacement
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
Study start: 14 Sep 2015 (actual)
Primary completion: 2 Jun 2017 (actual)
Study completion: 7 Jul 2017 (actual)
First posted: 11 Feb 2016 (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.

Detailed description

To test the null hypothesis we hypothesize as clinically relevant:

a reduction of 30% in the time needed to perform the Timed Up and Go test at 2 days after surgery
a reduction of 30% in pain medication consumption in the first 24 ore after surgery.

To test the null Hypothesis, 40 patients are needed (20 for each group).

The primary outcome measures will be:

the time required in the two groups (CACB-group and RF-group) to perform the Timed-Up and Go (TUG) test on the second postoperative day (POD2). TUG measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down. During the test, the person is expected to use any mobility aids that they would normally require.
the total morphine consumption by means of the patient-controlled analgesia pump over the first 24-h after surgery, which can be measured precisely through the record of the dose delivered by the PCA pump. With an alpha error of 0.05, a power of 80% and a standard deviation of 7 mg of morphine consumption per 24 h, 20 patients (10 in each group) will be required for the study to detect a mean difference of 10 mg of morphine between the two groups

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Pulsed and Continuous Radiofrequency	Experimental	Procedure: Pulsed and Continuous RadiofrequencyIn this group of patients undergoing total knee arthroplasty (allocation of patients is randomized), Pulsed radiofrequency (PRF) is applied to the saphenous nerve of the knee, associated to Continuous Radiofrequency (TRF) applied to the genicular nerves of the knee . A sham catheter is inserted in the mid-tigh to simulate a continuous adductor canal block, and connected to an infusion of normal saline (assessor and patient blinded to the treatment)
Continuous adductor canal block	Active comparator	Drug: Continuous Adductor Canal BlockContinuous Adductor Canal Block Continuous adductor canal block is performed in this group of patients, with a catheter infusing ropivacaine 0.2% in the first 48 hours after surgery. The solutions bags are labelled in order to make assessor and patients, blinded to the treatment (Ropivacaine vs Normal Saline)

Who may qualify

Ages: 45 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Diagnosis of knee Osteoarthritis requiring Total Knee Arthroplasty (TKA)

Key exclusion criteria (7 listed)

Previous TKA (revision surgery)
ASA (American Society of Anesthesiology) Classification > 3
Known Rheumatologic disease
Morbid Obesity (BMI > 45)
Inability to perform simple physical tasks (6 minutes walk test, Timed-Up and Go test)

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
Pulsed and Continuous RadiofrequencyAlso: PRFPreoperative pulsed radiofrequency of the saphenous nerve and Continuous radiofrequency of the genicular nerves of the knee joint. The saphenous nerve will be approached at the adductor canal and it will be treated with Pulsed RF for 4 minutes at 42 Celsius degrees. Ropivacaine 0.5% 10ml with Dexamethasone 10mg will be injected after the RF. The Genicular terminal branches of the sciatic and femoral nerves will be treated with Continuous RF for 3 min at 80 Celsius degrees and then with 2 ml of Ropivacaine 0.5% and 10 mg of Methylprednisolone to each nerve (5 in total) A sham catheter in the mid-thigh will be placed for patients in the RF group, infusing Normal Saline 0.9% and simulating a Continuous Adductor Canal Block. To blind the investigator to the type of treatment for the postoperative assessment , every solution bag will be prepared by the Pharmacy of the Hospital, covered with a plastic envelope and labeled as "Study Solution".	Procedure or surgery	Pulsed and Continuous Radiofrequency
Continuous Adductor Canal BlockAlso: CACBThe patients in the Adductor canal group, will have a catheter for peripheral nerve block inserted under strict asepsis in the adductor canal under ultrasound guidance, and will receive for postoperative analgesia a 48-h continuous infusion of Ropivacaine 0.2% at 8 ml/hour The patients will receive, intraoperatively 10 mg of Dexamethasone i.v. To blind the investigator who will do the postoperative assessment to the type of treatment, every solution bag will be prepared by the Pharmacy of the Hospital, covered with a plastic envelope and labeled as "Study Solution". It will be always possible to crack the code and find out to which group the patient belongs	Drug	Continuous adductor canal block

Primary outcome

Postoperative morphine consumption
Time frame: first postoperative day (first 24 hours)

9 secondary outcomes

Timed-Up and Go Test
Time frame: 2nd postoperative day
Six minutes walk test
Time frame: 6 weeks after surgery
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6 weeks after surgery
Visual Analogue Scale (VAS) for pain at rest
Time frame: 6 weeks after surgery
Visual Analogue Scale (VAS) for pain at movement
Time frame: 6 weeks after surgery
Pain medication consumption
Time frame: 6 weeks after surgery
Visual Analogue Scale (VAS) for pain at rest
Time frame: first 24 hours after surgery
Visual Analogue Scale (VAS) for pain at movement
Time frame: First 24 hours after surgery
CHAMPS (Community Healthy Activities Model Program for Seniors) questionnaire
Time frame: 6 weeks after 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 1 Oct 2021.
Results publication: PubMed 25468584Patterson ME, Bland KS, Thomas LC, Elliott CE, Soberon JR Jr, Nossaman BD, Osteen K. The adductor canal block provides effective analgesia similar to a femoral nerve block in patients undergoing total knee arthroplasty--a retrospective study. J Clin Anesth. 2015 Feb;27(1):39-44. doi: 10.1016/j.jclinane.2014.08.005. Epub 2014 Nov 22.
Results publication: PubMed 26079800Machi AT, Sztain JF, Kormylo NJ, Madison SJ, Abramson WB, Monahan AM, Khatibi B, Ball ST, Gonzales FB, Sessler DI, Mascha EJ, You J, Nakanote KA, Ilfeld BM. Discharge Readiness after Tricompartment Knee Arthroplasty: Adductor Canal versus Femoral Continuous Nerve Blocks-A Dual-center, Randomized Trial. Anesthesiology. 2015 Aug;123(2):444-56. doi: 10.1097/ALN.0000000000000741.
Results publication: PubMed 20551021Carli F, Clemente A, Asenjo JF, Kim DJ, Mistraletti G, Gomarasca M, Morabito A, Tanzer M. Analgesia and functional outcome after total knee arthroplasty: periarticular infiltration vs continuous femoral nerve block. Br J Anaesth. 2010 Aug;105(2):185-95. doi: 10.1093/bja/aeq112. Epub 2010 Jun 14.
Results publication: PubMed 25041873Shah NA, Jain NP. Is continuous adductor canal block better than continuous femoral nerve block after total knee arthroplasty? Effect on ambulation ability, early functional recovery and pain control: a randomized controlled trial. J Arthroplasty. 2014 Nov;29(11):2224-9. doi: 10.1016/j.arth.2014.06.010. Epub 2014 Jun 19.
Results publication: PubMed 24121608Jaeger P, Zaric D, Fomsgaard JS, Hilsted KL, Bjerregaard J, Gyrn J, Mathiesen O, Larsen TK, Dahl JB. Adductor canal block versus femoral nerve block for analgesia after total knee arthroplasty: a randomized, double-blind study. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):526-32. doi: 10.1097/AAP.0000000000000015.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis, Knee

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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.

Francesco Carli, Professor study director

Mc Gill Univeristy Health Center

Juan Francisco Asenjo, Professor principal investigator

Mc Gill Univeristy Health Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 inclusion and 7 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 1 Oct 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 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.

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?

Postoperative morphine consumption (time frame: first postoperative day (first 24 hours)). 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 NCT02680392, 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 1 Oct 2021.