Regional Anesthesia in Total Hip and Knee Arthroplasty

NCT ID: NCT04257682

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-02-28

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.

Conditions

Knee Osteoarthritis; Hip Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: 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.

Ropivacaine

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: 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.

Mepivacaine

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

Group Type: ACTIVE_COMPARATOR

Mepivacaine

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Local Anesthetic; Local Anesthetic; Local Anesthetic

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Faraj Abdallah

Role: CONTACT

fabdallah@toh.ca

613-613-737-8899 ext. 71887

Meaghan Dufresne

Role: CONTACT

meadufresne@ohri.ca

613-737-8899 ext. 73032

Other Identifiers

20190297-01H

Identifier Type: -

Identifier Source: org_study_id