Comparing Exparel & Ropivacaine for Pain Relief in Total Knee Arthroplasty

NCT ID: NCT02607579

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-07-31

Brief Summary

The purpose of this prospective study is to examine the effect of two local anesthetics used in adductor canal blocks, with relation to pain, analgesic consumption, mobility, and pain related interference with activities and hospital length of stay. The two agents are bupivacaine and ropivacaine. The purpose of this trial is to examine the effect of these drugs being used in adductor canal blocks for pain relief, analgesic consumption, mobility, and pain related interference with activities and hospital length of stay.

Detailed Description

Total knee arthroplasty (TKA) is associated with intense early postoperative pain. Effective pain management following total knee arthroplasty is imperative to facilitate early ambulation, mobilization and rehabilitation. The postoperative pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. To manage postoperative pain effectively, multimodal analgesia including acetaminophen, Toradol, Solu-Medrol, opioids and local anesthetics are used. Periarticular infiltration performed intra-operatively combined with ultrasound guided adductor-canal peripheral nerve blocks are effective in reducing pain following a TKA without causing quadriceps motor block which can impede mobilization. There are no published trials that the investigators could find to date, comparing adductor canal block with a single dose Exparel and adductor canal block with standard ropivacaine.

A liposome is a manufactured spherical lipid vesicle that can be used to slowly release a drug thereby extending its duration of action. Exparel is such a compound that slowly releases bupivacaine. Local anesthetics block the conduction of all excitable tissue in a dose related fashion. The first tissues that are affected are nerves, which make these drugs of choice in neural block. Their local adverse effects include neurovascular manifestations are prolonged numbness, tingling, feeling of "pins and needles" or strange sensations. These effects are reversed with time. There are no additional potential risks or adverse effects due to the procedures or drugs being administered. The procedure is well established and the local anesthetics have a history of long term use in humans.

Conditions

Knee Osteoarthritis

Study Design

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

Study Groups

Ropivacaine

This group is given an adductor canal block with Ropivacaine which is the previous gold standard medication.

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

Exparel

This group is given an adductor canal block with Exparel which is believed to last longer and provide a better pain relief post-operatively.

Group Type: EXPERIMENTAL

Exparel

Intervention Type: DRUG

Interventions

Exparel

Intervention Type: DRUG

Ropivacaine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18 and up undergoing a total knee replacement with single surgeon. American Society of Anesthesiologists Physical Status Classification Scale (ASA) 1-3.

Exclusion Criteria

• Allergy to local anesthestic, pre-existing peripheral neuropathy, revision surgery

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Monmouth Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ryan Plyler

Orthopaedic Surgeon/ Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Monmouth Medical Center

Long Branch, New Jersey, United States

Countries

United States

Other Identifiers

14-045

Identifier Type: -

Identifier Source: org_study_id