Regional Anesthesia in Total Hip and Knee Arthroplasty

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis; Hip Osteoarthritis
• Intervention / Treatment: Drug: Bupivacaine; Drug: Ropivacaine; Drug: Mepivacaine

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 Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Faraj Abdallah; Phone Number: 71887 613-613-737-8899; Email: fabdallah@toh.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Effectiveness will be measured by looking at the proportion of patients with a failed spinal anesthetic.	Day of surgery
Compare the cost profile of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.	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	Hospital discharge, approximately 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare changes in post-operative pain associated with Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.	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.	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
Compare the safety of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.	Safety parameters will be compared by recording Adverse Events (AE)	24 hours after surgery, one week post-operatively
Compare the quality of the block provided by Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.	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.	During surgery, PACU discharge - approximately 3 hours
Compare the length of stay for patients who received Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.	Length of stay will be compared by recording the time of PACU discharge, SDC discharge, and hospital discharge.	Immediately after surgery, PACU discharge - approximately 3 hours, SDC discharge - approximately 1 day, hospital discharge - approximately 1 day

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 8, 2022
• Last Update Submitted That Met QC Criteria: August 5, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine; Mepivacaine
• Other Study ID Numbers: 20190297-01H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No