Local Injection of Local Anesthetic 24 Hours After Knee Replacement Surgery May Decrease Pain for Several More Hours
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
The purpose of this study is to determine if an additional injection of local anesthetic immediately prior to removal of the local anesthetic infiltration catheter on postoperative day one is effective in increasing pain reduction, patient satisfaction or outcome measures following total knee replacement (TKR). It is hypothesized that an additional injection of 30ml of .5% bupivacaine solution immediately before infiltration catheter removal will provide pain reduction, patient satisfaction and outcome measures equal or superior to catheter removal with no additional injection. Patients who are undergoing unilateral total knee replacement (TKR) and choose to participate will be randomly assigned to a treatment group.Patients in group one (treatment group) will receive a 30ml dose of .5% bupivacaine solution injected into the local anesthetic infiltration catheter immediately prior to its removal on postoperative day one. Patients in group two (control group) will receive no additional medication during local anesthetic infiltration catheter removal.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2015
CompletedFirst Posted
Study publicly available on registry
April 20, 2015
CompletedStudy Start
First participant enrolled
October 5, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2016
CompletedResults Posted
Study results publicly available
March 31, 2017
CompletedJanuary 12, 2018
December 1, 2017
6 months
January 28, 2015
January 30, 2017
December 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Assessed Using the VAS 0-10 Pain Scale
Pain will be assessed using the VAS 0-10 pain scale. 0 is no pain and 10 in worst imaginable pain.
7 days
Secondary Outcomes (5)
Pain Med Consumption Assessed Using Questionnaire/Hospital Records
2 days
Pain Med Consumption Assessed Using Questionnaire/Hospital Records
7 days
Swelling Measured Using a Perometer
7 days
Proprioception Measured Using a SD Balancer
7 days
Quadriceps Strength Measured Using a Biodex Handheld Dynamometer"
7 days
Study Arms (2)
Injection
EXPERIMENTALWill receive injection of 30ml of .5% bupivacaine solution prior to catheter removal
No Injection
ACTIVE COMPARATORWill not receive injection of bupivacaine prior to catheter removal
Interventions
Injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
No injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
Eligibility Criteria
You may qualify if:
- At least 18 years of age
- Undergoing unilateral knee replacement
- If female, not pregnant
- Agree to participate in the follow-up appointment
- Understand and sign the informed consent form
You may not qualify if:
- Bilateral TKA planned
- Use of narcotic medication before surgery
- Any other surgery within the three months prior to TKR
- Inflammatory arthritis
- Any chronic pain conditions or problems, including but not limited to chronic back pain, fibromyalgia or multiple sclerosis
- Osteoarthritis of the non-operative knee
- Osteoarthritis of one or both hips
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
Chaumeron A, Audy D, Drolet P, Lavigne M, Vendittoli PA. Periarticular injection in knee arthroplasty improves quadriceps function. Clin Orthop Relat Res. 2013 Jul;471(7):2284-95. doi: 10.1007/s11999-013-2928-4. Epub 2013 Mar 21.
PMID: 23516031BACKGROUNDBarrington JW, Halaszynski TM, Sinatra RS, Expert Working Group On Anesthesia And Orthopaedics Critical Issues In Hip And Knee Replacement Arthroplasty FT. Perioperative pain management in hip and knee replacement surgery. Am J Orthop (Belle Mead NJ). 2014 Apr;43(4 Suppl):S1-S16.
PMID: 24911869BACKGROUNDTeng Y, Jiang J, Chen S, Zhao L, Cui Z, Khan MS, Du W, Gao X, Wang J, Xia Y. Periarticular multimodal drug injection in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2014 Aug;22(8):1949-57. doi: 10.1007/s00167-013-2566-0. Epub 2013 Jun 20.
PMID: 23783531BACKGROUNDJiang J, Teng Y, Fan Z, Khan MS, Cui Z, Xia Y. The efficacy of periarticular multimodal drug injection for postoperative pain management in total knee or hip arthroplasty. J Arthroplasty. 2013 Dec;28(10):1882-7. doi: 10.1016/j.arth.2013.06.031. Epub 2013 Aug 1.
PMID: 23910819BACKGROUNDNational Center for Health Statistics. National Hospital Discharge Survey, 2010. Hyattsville, Maryland: Public Health Service. 2010.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Wolfgang Fitz
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Wolfgang Fitz, MD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Orthopedic Surgeon
Study Record Dates
First Submitted
January 28, 2015
First Posted
April 20, 2015
Study Start
October 5, 2015
Primary Completion
March 22, 2016
Study Completion
December 9, 2016
Last Updated
January 12, 2018
Results First Posted
March 31, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share