Regional Anesthesia in Total Hip and Knee Arthroplasty

Phase 4

• Conditions: Knee Osteoarthritis; Hip Osteoarthritis
• Interventions: Drug: Bupivacaine; Drug: Ropivacaine; Drug: Mepivacaine

• Registration Number: NCT04257682
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2020-02-03
• Study First Posted: 2020-02-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-08
• Study Start: 2022-09
• Primary Completion: 2023-02
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine	Bupivacaine	The participant will receive Bupivacaine as anesthesia during his or her planned total hip or knee replacement surgery.
Ropivacaine	Ropivacaine	The participant will receive Ropivacaine as anesthesia during his or her planned total hip or knee replacement surgery.
Mepivacaine	Mepivacaine	The participant will receive Mepivacaine as anesthesia during his or her planned total hip or knee replacement surgery.

Primary Outcome Measures

Name	Time	Method
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	Day of surgery	Effectiveness will be measured by looking at the proportion of patients with a failed spinal anesthetic.
Compare the cost profile of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.	Hospital discharge, approximately 1 day	Total costs associated with the providers involved and the costs associated with the time spent in the hospital following surgery but before discharge will be combined to report the cost profile

Secondary Outcome Measures

Name	Time	Method
Compare changes in post-operative pain associated with Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.	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	Post-operative pain will be measured using a combination of the Visual Analogue Scale Pain Scores (VAS), time to first analgesic request in PACU, and recording post-operative opioid use.
Compare the safety of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.	24 hours after surgery, one week post-operatively	Safety parameters will be compared by recording Adverse Events (AE)
Compare the quality of the block provided by Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.	During surgery, PACU discharge - approximately 3 hours	Quality of the block will compared by combing the the duration of total sensory and motor blocks and the number of patients who do not achieve a block at time of incision.
Compare the length of stay for patients who received Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.	Immediately after surgery, PACU discharge - approximately 3 hours, SDC discharge - approximately 1 day, hospital discharge - approximately 1 day	Length of stay will be compared by recording the time of PACU discharge, SDC discharge, and hospital discharge.