Clinical trial NCT04257682: Regional Anesthesia in Total Hip and Knee Arthroplasty
Official title: Comparing Efficacy and Safety of Three Regional Anesthesia Regimens in Total Hip and Knee Arthroplasty: A Double Blind Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Osteoarthritis
Hip Osteoarthritis
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 135
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether the use of Ropivacaine and Mepivacaine are better in terms of effectiveness, cost, and safety than Bupivacaine as regional anesthetics in elective hip or knee replacement surgery.

Detailed description: Advances in pain management, regional anesthesia, and focused rehabilitation have increased the popularity of outpatient total hip and knee arthroplasty in a select group of eligible patients. However, one of the main impediments to same-day discharge is the prolonged motor block post-spinal anesthesia, as patients are routinely kept in the post-anesthesia care unit (PACU) until they demonstrate that the spinal anesthesia has worn off.

At The Ottawa Hospital, the standard treatment for people receiving anesthesia during a total arthroplasty is the use of the anaesthetic, Bupivacaine. Mepivacaine and Ropivacaine are alternative anaesthetics that are also in use at The Ottawa Hospital. They are growing in popularity as anaesthetics because they and allow quicker recovery time when compared to Bupivacaine. Bupivacaine results in a long-lasting sensory-motor block, meaning that in the area that the local anesthesia was used, there is no sensation and limited movement for long periods of time. During hip or knee replacement surgery, you may want to have no sensation and the inability to move your lower limbs. However, it is not ideal for after surgery where weakness in the legs puts a person at increased risk for falls. Therefore, hospitalization after surgery typically lasts for a longer duration. Mepivacaine and Ropivacaine have a shorter motor block duration, allowing for a potentially earlier hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing total hip or knee replacement

Exclusion Criteria:

* Study refusal
* Inability to provide consent
* Contra-indications to spinal anesthesia (refusal, infection, anti-coagulation, bleeding diathesis)
* Bilateral surgery
* Revision surgery
* Pre-exiting chronic pain or opioid consumption ≥ 30mg oxycodone or equivalent
* Pregnancy
* Not receiving preoperative adductor canal block for any reason
* Contra-indication to multimodal analgesia (acetaminophen or NSAIDs)
* Obstructive sleep apnea requiring extended PACU stay
* History of severe postoperative nausea and vomiting

Primary outcomes:
measure: Compare the effectiveness of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine: proportion of patients with a failed spinal anesthetic
timeFrame: Day of surgery
measure: Compare the cost profile of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
timeFrame: Hospital discharge, approximately 1 day
Secondary outcomes:
measure: Compare changes in post-operative pain associated with Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
timeFrame: Immediately after completion of surgery, every hour during PACU stay - approximately 3 hours, every 6 hours during hospital stay - approximately 1 day, 24 hours after surgery, one week post-operatively
measure: Compare the safety of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
timeFrame: 24 hours after surgery, one week post-operatively
measure: Compare the quality of the block provided by Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
timeFrame: During surgery, PACU discharge - approximately 3 hours
measure: Compare the length of stay for patients who received Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
timeFrame: Immediately after surgery, PACU discharge - approximately 3 hours, SDC discharge - approximately 1 day, hospital discharge - approximately 1 day
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