Comparing Exparel & Ropivacaine for Pain Relief in Total Knee Arthroplasty

Sponsor
Monmouth Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02607579
Collaborator
(none)
200
1
2
30
6.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Blinded Study to Compare Exparel and Ropivacaine for Pain Relief Following Total Knee Arthroplasty
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Jul 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ropivacaine

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

Drug: Ropivacaine

Experimental: 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.

Drug: Exparel

Outcome Measures

Primary Outcome Measures

  1. Pain relief [Hospital course (approximately 2-3 days)]

    The investigators will monitor patient pain scores every 6 hours during the hospital stay based on the Defense and Veterans Pain Rating Scale (DVPRS).

Secondary Outcome Measures

  1. Length of stay [Hospital course (approximately 2-3 days)]

    The investigators will compare the length of stay between the two groups.

  2. Post-Operative Range of Motion [Hospital course (approximately 2-3 days)]

    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.

  3. Post-Operative Distance Walked [Hospital course (approximately 2-3 days)]

    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.

  4. Amount of Narcotics required [Hospital course (approximately 2-3 days)]

    The investigators will monitor the amount of medication taken by participants during the hospital stay.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Monmouth Medical Center Long Branch New Jersey United States 07740

Sponsors and Collaborators

  • Monmouth Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ryan Plyler, Orthopaedic Surgeon/ Researcher, Monmouth Medical Center
ClinicalTrials.gov Identifier:
NCT02607579
Other Study ID Numbers:
  • 14-045
First Posted:
Nov 18, 2015
Last Update Posted:
Apr 27, 2017
Last Verified:
Apr 1, 2017
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2017