A Phase 4 interventional study of Adductor Canal Block and Adductor Canal Block with Morphine in Total Knee Arthroplasty, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-11-24.
Sponsored by University Health Network, Toronto · Phase 4, Interventional, and Treatment
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
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.
University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group will receive LIA and saline solution (placebo) in the adductor canal block with NO morphine in the spinal anesthesia: * 30 ml normal saline * 3ml 0.5% preservative-free bupivacaine
Drug: Local Infiltration
This group will receive LIA and the standard local anesthetic in the ACB with NO morphine in the spinal anesthetic: * ropivacaine 0.5% with 1:400,000 epinephrine * 3ml 0.5% preservative-free bupivacaine
Drug: Adductor Canal Block
This group will receive LIA with local anesthetic in the ACB and morphine in the spinal anesthetic: * ropivacaine 0.5% with 1:400,000 epinephrine * 3ml 0.5% preservative-free bupivacaine with 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml)
Drug: Adductor Canal Block with Morphine
Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine.
Also known as: ropivacaine with epinephrine
Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine and 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml)
Also known as: ropivacaine with epinephrine and spinal intrathecal morphine
30 ml normal saline in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine, in addition to the local infiltration.
Also known as: saline
Timed Up and Go test
TUG test reflects the time it takes a subject to stand up from a standard height armchair, walk 3 meters, walk back to the chair and sit down. It intends to assess a patient's global mobility as well as balance and risk of falling.
Time frame: 2-3 days post srugery
Pain outcome - NRS
a) Pain scores assessed with an 11 point verbal numeric rating scale (NRS) where 0 is "no pain" and 10 is "the worst pain imaginable", both at rest and during active physiotherapy (measured daily for 3 days post-operatively) .
Time frame: 2-3 days post surgery
Analgesic outcomes - Cumulative systemic opioid consumption
Cumulative systemic opioid consumption measured as oral morphine mg equivalents (daily for 3 days post-operatively).
Time frame: 2-3 days post surgery
Analgesic outcomes - Proportion of patients who required "rescue" intravenous patient controlled analgesia
Proportion of patients who required "rescue" intravenous patient controlled analgesia (iv PCA) anytime in the post-operative period.
Time frame: 2-3 days post surgery
Analgesic outcomes - Incidence of opioid-related side effects
Incidence of opioid-related side effects
Time frame: 2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees
Proportion of patients achieving knee flexion range of motion (ROM) of 90 degrees (measured daily for 3 days post-operatively)
Time frame: 2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Distance walked
Distance walked
Time frame: 2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Hospital length of stay
Hospital length of stay
Time frame: 2-3 days post surgery
Secondary short-term physical and performance-based functional outcome measures - Discharge destination
Discharge destination (home or rehabilitation facility)
Time frame: 2-3 days post surgery
Medium-term self-reported functional outcome measures - WOMAC
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) measured at baseline and at 3 months post-operatively
Time frame: baseline and 2-3 days post surgery
Medium-term self-reported functional outcome measures - LEFS
Lower extremity functional scale (LEFS) measured at baseline and at 3 months post-operatively.
Time frame: baseline and 2-3 days post surgery
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University Health Network, Toronto