Comparing Exparel & Ropivacaine for Pain Relief in Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

A Randomized, Blinded Study to Compare Exparel and Ropivacaine for Pain Relief Following Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02607579
• Other study ID #: 14-045
• Status: Active, not recruiting
• Phase: N/A
• First received: July 27, 2015
• Last updated: April 26, 2017
• Start date: January 2015
• Est. completion date: July 2017

Study information

• Verified date: April 2017
• Source: Monmouth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Exparel

• Ropivacaine

Locations

Country	Name	City	State
United States	Monmouth Medical Center	Long Branch	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Monmouth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain relief	The investigators will monitor patient pain scores every 6 hours during the hospital stay based on the Defense and Veterans Pain Rating Scale (DVPRS).	Hospital course (approximately 2-3 days)
Secondary	Length of stay	The investigators will compare the length of stay between the two groups.	Hospital course (approximately 2-3 days)
Secondary	Post-Operative Range of Motion	The investigators will compare the range of motion between the two groups during the participants' hospital course as measured by the physical therapists on a daily basis.	Hospital course (approximately 2-3 days)
Secondary	Post-Operative Distance Walked	The investigators will compare the distance walked between the two groups during the participants' hospital course as measured by the physical therapists on a daily basis.	Hospital course (approximately 2-3 days)
Secondary	Amount of Narcotics required	The investigators will monitor the amount of medication taken by participants during the hospital stay.	Hospital course (approximately 2-3 days)