Regional Anesthesia in Total Hip and Knee Arthroplasty

NCT04257682 | Unknown Phase 4 DMC

• 1 other identifier: 20190297-01H
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis; Hip Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (3)

Bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Ropivacaine

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Mepivacaine

ACTIVE COMPARATOR

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

Drug: Mepivacaine

Interventions

Bupivacaine DRUG

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.

Also known as: Local Anesthetic

Bupivacaine

Ropivacaine DRUG

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.

Also known as: Local Anesthetic

Ropivacaine

Mepivacaine DRUG

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.

Also known as: Local Anesthetic

Mepivacaine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing total hip or knee replacement

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

Bupivacaine; Anesthetics, Local; Ropivacaine; Mepivacaine

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Faraj Abdallah

CONTACT

613-613-737-8899; fabdallah@toh.ca

Meaghan Dufresne

CONTACT

613-737-8899; meadufresne@ohri.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: February 6, 2020
• Study Start: September 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: August 8, 2022

Record last verified: 2022-08