Regional Anesthesia in Total Hip and Knee Arthroplasty

Sponsor

Ottawa Hospital Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04257682

Collaborator

(none)

135

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis Hip Osteoarthritis	Drug: Bupivacaine Drug: Ropivacaine Drug: Mepivacaine	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

135 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparing Efficacy and Safety of Three Regional Anesthesia Regimens in Total Hip and Knee Arthroplasty: A Double Blind Randomized Control Trial

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bupivacaine The participant will receive Bupivacaine as anesthesia during his or her planned total hip or knee replacement surgery.	Drug: Bupivacaine Bupivacaine is a long-lasting dense sensory-motor block that can last up to four hours. It will be administered once, as part of the spinal anesthetic. The dosage varies based on age and joint, from 6.75 mg to 8.25 mg for the knee, and 7.5 mg to 9 mg for the hip. Other Names: Local Anesthetic
Active Comparator: Ropivacaine The participant will receive Ropivacaine as anesthesia during his or her planned total hip or knee replacement surgery.	Drug: Ropivacaine Ropivacaine is a long-acting local anesthetic that is known for its differential sensory-motor block. It will be administered once, as part of the spinal anesthetic. The dosage varies based on age and joint, from 9 mg to 11 mg for the knee, and 10 mg to 12 mg for the hip. Other Names: Local Anesthetic
Active Comparator: Mepivacaine The participant will receive Mepivacaine as anesthesia during his or her planned total hip or knee replacement surgery.	Drug: Mepivacaine Mepivacaine is an intermediate-acting local anesthetic producing shorting and motor-sparing blocks. It will be administered once, as part of the spinal anesthetic. The dosage varies based on age and joint, from 40 mg to 50 mg for the knee, and 45 mg to 55 mg for the hip. Other Names: Local Anesthetic

Arm

Intervention/Treatment

Active Comparator: Bupivacaine

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

Drug: Bupivacaine

Bupivacaine is a long-lasting dense sensory-motor block that can last up to four hours. It will be administered once, as part of the spinal anesthetic. The dosage varies based on age and joint, from 6.75 mg to 8.25 mg for the knee, and 7.5 mg to 9 mg for the hip.

Other Names:

Local Anesthetic

Active Comparator: Ropivacaine

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

Drug: Ropivacaine

Ropivacaine is a long-acting local anesthetic that is known for its differential sensory-motor block. It will be administered once, as part of the spinal anesthetic. The dosage varies based on age and joint, from 9 mg to 11 mg for the knee, and 10 mg to 12 mg for the hip.

Other Names:

Local Anesthetic

Active Comparator: Mepivacaine

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

Drug: Mepivacaine

Mepivacaine is an intermediate-acting local anesthetic producing shorting and motor-sparing blocks. It will be administered once, as part of the spinal anesthetic. The dosage varies based on age and joint, from 40 mg to 50 mg for the knee, and 45 mg to 55 mg for the hip.

Other Names:

Local Anesthetic

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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