Regional Anesthesia in Total Hip and Knee Arthroplasty

Ottawa Hospital Research Institute

Status and phase: Not yet enrolling; Phase 4

Conditions: Hip Osteoarthritis; Knee Osteoarthritis

Treatments: Drug: Mepivacaine; Drug: Ropivacaine; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04257682

20190297-01H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 3 patient groups

Bupivacaine

Active Comparator group

Description:

The participant will receive Bupivacaine as anesthesia during his or her planned total hip or knee replacement surgery.

Treatment:

Drug: Bupivacaine

Ropivacaine

Active Comparator group

Description:

The participant will receive Ropivacaine as anesthesia during his or her planned total hip or knee replacement surgery.

Treatment:

Drug: Ropivacaine

Mepivacaine

Active Comparator group

Description:

The participant will receive Mepivacaine as anesthesia during his or her planned total hip or knee replacement surgery.

Treatment:

Drug: Mepivacaine