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Regional Anesthesia in Total Hip and Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04257682
Recruitment Status : Not yet recruiting
First Posted : February 6, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
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.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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 Name: 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 Name: 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 Name: Local Anesthetic




Primary Outcome Measures :
  1. 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 [ Time Frame: Day of surgery ]
    Effectiveness will be measured by looking at the proportion of patients with a failed spinal anesthetic.

  2. Compare the cost profile of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine. [ Time Frame: 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 :
  1. Compare changes in post-operative pain associated with Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine. [ 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 ]
    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.

  2. Compare the safety of Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine. [ Time Frame: 24 hours after surgery, one week post-operatively ]
    Safety parameters will be compared by recording Adverse Events (AE)

  3. Compare the quality of the block provided by Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine. [ Time Frame: 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.

  4. Compare the length of stay for patients who received Ropivacaine and Mepivacaine spinal anesthetics to the current standard of care using Bupivacaine. [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04257682


Contacts
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Contact: Faraj Abdallah 613-613-737-8899 ext 71887 fabdallah@toh.ca
Contact: Meaghan Dufresne 613-737-8899 ext 73032 meadufresne@ohri.ca

Sponsors and Collaborators
Ottawa Hospital Research Institute
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04257682    
Other Study ID Numbers: 20190297-01H
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020

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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
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
Ropivacaine
Anesthetics, Local
Mepivacaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents