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

NCT02680392 | Completed

• 1 other identifier: 15-209-MUHC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

Pulsed and Continuous Radiofrequency Treatment; Continuous adductor canal block; Postoperative pain; Functional recovery; Total Knee Joint Replacement

Outcome Measures

Primary Outcomes (1)

• Postoperative morphine consumption

  first postoperative day (first 24 hours)

Secondary Outcomes (9)

• Timed-Up and Go Test

  2nd postoperative day

• Six minutes walk test

  6 weeks after surgery

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  6 weeks after surgery

• Visual Analogue Scale (VAS) for pain at rest

  6 weeks after surgery

• Visual Analogue Scale (VAS) for pain at movement

  6 weeks after surgery

Study Arms (2)

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)

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)

Drug: Continuous Adductor Canal Block

Interventions

Pulsed and Continuous Radiofrequency PROCEDURE

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".

Also known as: PRF

Pulsed and Continuous Radiofrequency

Continuous Adductor Canal Block DRUG

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

Also known as: CACB

Continuous adductor canal block

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre, Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Location

Related Publications (5)

• 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.

  PMID: 25468584 RESULT

• 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.

  PMID: 26079800 RESULT

• 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.

  PMID: 20551021 RESULT

• 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.

  PMID: 25041873 RESULT

• 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.

  PMID: 24121608 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative

Interventions

Heart Rate

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Francesco Carli, Professor

  Mc Gill Univeristy Health Center

  STUDY DIRECTOR

• Juan Francisco Asenjo, Professor

  Mc Gill Univeristy Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: February 11, 2016
• Study Start: September 14, 2015
• Primary Completion: June 2, 2017
• Study Completion: July 7, 2017
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)