Clinical trial NCT02680392: Functional Outcome and Analgesia in TKA: Radiofrequency vs Continuous Adductor Canal Block
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: Pulsed and Continuous Radiofrequency Treatment
Continuous adductor canal block
Postoperative pain
Functional recovery
Total Knee Joint Replacement
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2016-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* Diagnosis of knee Osteoarthritis requiring Total Knee Arthroplasty (TKA)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postoperative morphine consumption
timeFrame: first postoperative day (first 24 hours)
Secondary outcomes:
measure: Timed-Up and Go Test
timeFrame: 2nd postoperative day
measure: Six minutes walk test
timeFrame: 6 weeks after surgery
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 6 weeks after surgery
measure: Visual Analogue Scale (VAS) for pain at rest
timeFrame: 6 weeks after surgery
measure: Visual Analogue Scale (VAS) for pain at movement
timeFrame: 6 weeks after surgery
measure: Pain medication consumption
timeFrame: 6 weeks after surgery
measure: Visual Analogue Scale (VAS) for pain at rest
timeFrame: first 24 hours after surgery
measure: Visual Analogue Scale (VAS) for pain at movement
timeFrame: First 24 hours after surgery
measure: CHAMPS (Community Healthy Activities Model Program for Seniors) questionnaire
timeFrame: 6 weeks after surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre, Montreal General Hospital
state: Quebec
Study officials:
affiliation: Mc Gill Univeristy Health Center
name: Francesco Carli, Professor
role: STUDY_DIRECTOR
affiliation: Mc Gill Univeristy Health Center
name: Juan Francisco Asenjo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.