Regional Anesthesia in Total Hip and Knee Arthroplasty
Primary Purpose
Knee Osteoarthritis, Hip Osteoarthritis
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bupivacaine
Ropivacaine
Mepivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Bupivacaine
Ropivacaine
Mepivacaine
Arm Description
The participant will receive Bupivacaine as anesthesia during his or her planned total hip or knee replacement surgery.
The participant will receive Ropivacaine as anesthesia during his or her planned total hip or knee replacement surgery.
The participant will receive Mepivacaine as anesthesia during his or her planned total hip or knee replacement surgery.
Outcomes
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
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.
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.
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.
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.
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.
Length of stay will be compared by recording the time of PACU discharge, SDC discharge, and hospital discharge.
Full Information
NCT ID
NCT04257682
First Posted
December 20, 2019
Last Updated
August 5, 2022
Sponsor
Ottawa Hospital Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04257682
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Hip Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
The participant will receive Bupivacaine as anesthesia during his or her planned total hip or knee replacement surgery.
Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Description
The participant will receive Ropivacaine as anesthesia during his or her planned total hip or knee replacement surgery.
Arm Title
Mepivacaine
Arm Type
Active Comparator
Arm Description
The participant will receive Mepivacaine as anesthesia during his or her planned total hip or knee replacement surgery.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Local Anesthetic
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Local Anesthetic
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Mepivacaine
Other Intervention Name(s)
Local Anesthetic
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
Effectiveness will be measured by looking at the proportion of patients with a failed spinal anesthetic.
Time Frame
Day of surgery
Title
Compare the cost profile of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
Description
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
Time Frame
Hospital discharge, approximately 1 day
Secondary Outcome Measure Information:
Title
Compare changes in post-operative pain associated with Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
Description
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.
Time Frame
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
Title
Compare the safety of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
Description
Safety parameters will be compared by recording Adverse Events (AE)
Time Frame
24 hours after surgery, one week post-operatively
Title
Compare the quality of the block provided by Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
Description
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.
Time Frame
During surgery, PACU discharge - approximately 3 hours
Title
Compare the length of stay for patients who received Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine.
Description
Length of stay will be compared by recording the time of PACU discharge, SDC discharge, and hospital discharge.
Time Frame
Immediately after surgery, PACU discharge - approximately 3 hours, SDC discharge - approximately 1 day, hospital discharge - approximately 1 day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faraj Abdallah
Phone
613-613-737-8899
Ext
71887
Email
fabdallah@toh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Meaghan Dufresne
Phone
613-737-8899
Ext
73032
Email
meadufresne@ohri.ca
12. IPD Sharing Statement
Learn more about this trial
Regional Anesthesia in Total Hip and Knee Arthroplasty
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