Clinical trial NCT02411149: Adductor Canal Block and Recovery After Total Knee Replacement Surgery
Official title: Adductor Canal Block and Functional Recovery After Total Knee Arthroplasty. A Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Keywords: Adductor Canal Block
Total Knee Arthroplasty
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the functional recovery of patients undergoing Total Knee Arthroplasty based on the administration of an adductor canal block during their anesthesia treatment

Detailed description: The period after total knee replacement (TKR) surgery is known to be painful for the first 24 hours, lasting up to 3 days in many cases. Successful management of pain after TKR is regarded as necessary to early recovery, rehabilitation and timely discharge. Severe pain following major joint arthroplasty can hinder early rehabilitation, may result in prolonged hospitalization and is a strong predictor of persistent pain beyond 3 months. Adequate analgesia following TKR is paramount to early recovery, rehabilitation and timely discharge. Therefore early postoperative analgesic and rehabilitation goals are intricately related.

Until now, different methods of pain treatment have been used, including intravenous narcotic pain medication, continuous femoral nerve block (numbing medication to a nerve in the thigh) and epidural analgesia (identical to the numbing method for childbirth). These are all effective methods but each is limited by side effects. In recent years, research has focused on administering local anesthetic further down in the leg, trying to minimize quadriceps muscle weakness while giving adequate pain relief after surgery. Local Infiltration Analgesia (LIA) and Adductor Canal Block (ACB) are examples of new farther sites of administration.

The purpose of this study is to determine which combination of analgesic interventions is the most effective treatment for pain and improvement in functional outcome for TKR.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Physical Status I-III
* 18 - 80 years of age
* BMI 18 - 40
* Scheduled for elective total knee replacement under spinal anesthesia
* Able to ambulate independently with a standard wheeled walker as maximum mobility aid

Exclusion Criteria:

* Revision knee arthroplasty
* Bilateral knee arthroplasty
* Lack of mental ability to provide informed consent
* Neuropathic pain or sensory disorders of the surgical limb
* Contraindication to regional anesthesia (intolerance to the study drugs, bleeding diathesis, coagulopathy, malignancy or infection at the site of block)
* Chronic opioid use defined as \> 30 mg of daily oral morphine equivalents

Primary outcomes:
measure: Timed Up and Go test
timeFrame: 2-3 days post srugery
Secondary outcomes:
measure: Pain outcome - NRS
timeFrame: 2-3 days post surgery
measure: Analgesic outcomes - Cumulative systemic opioid consumption
timeFrame: 2-3 days post surgery
measure: Analgesic outcomes - Proportion of patients who required "rescue" intravenous patient controlled analgesia
timeFrame: 2-3 days post surgery
measure: Analgesic outcomes - Incidence of opioid-related side effects
timeFrame: 2-3 days post surgery
measure: Secondary short-term physical and performance-based functional outcome measures - Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees
timeFrame: 2-3 days post surgery
measure: Secondary short-term physical and performance-based functional outcome measures - Distance walked
timeFrame: 2-3 days post surgery
measure: Secondary short-term physical and performance-based functional outcome measures - Hospital length of stay
timeFrame: 2-3 days post surgery
measure: Secondary short-term physical and performance-based functional outcome measures - Discharge destination
timeFrame: 2-3 days post surgery
measure: Medium-term self-reported functional outcome measures - WOMAC
timeFrame: baseline and 2-3 days post surgery
measure: Medium-term self-reported functional outcome measures - LEFS
timeFrame: baseline and 2-3 days post surgery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University of Toronto. University Health Network. Toronto Western Hospital.
name: Anahi Perlas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Puolakka PA, Rorarius MG, Roviola M, Puolakka TJ, Nordhausen K, Lindgren L. Persistent pain following knee arthroplasty. Eur J Anaesthesiol. 2010 May;27(5):455-60. doi: 10.1097/EJA.0b013e328335b31c.
citation: Capdevila X, Barthelet Y, Biboulet P, Ryckwaert Y, Rubenovitch J, d'Athis F. Effects of perioperative analgesic technique on the surgical outcome and duration of rehabilitation after major knee surgery. Anesthesiology. 1999 Jul;91(1):8-15. doi: 10.1097/00000542-199907000-00006.
citation: Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63. doi: 10.2106/JBJS.E.00344.
citation: Biswas A, Perlas A, Ghosh M, Chin K, Niazi A, Pandher B, Chan V. Relative Contributions of Adductor Canal Block and Intrathecal Morphine to Analgesia and Functional Recovery After Total Knee Arthroplasty: A Randomized Controlled Trial. Reg Anesth Pain Med. 2018 Feb;43(2):154-160. doi: 10.1097/AAP.0000000000000724.