Local Infiltration With Bupivacaine to Increase Quality of Post-operative Pain Control in Total Knee Replacement
Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain, Postoperative; Arthropathy of Knee Joint
Intervention: 0.25% Bupivacaine (Drug); 0.9% normal saline (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Mahidol University Official(s) and/or principal investigator(s): Keerati Chareancholvanich, MD, Principal Investigator, Affiliation: Siriraj Hospital
Summary
The purpose of this study is to evaluate the efficacy of periarticular injection with 0. 25%
bupivacaine for controlling pain after total knee replacement to improve the quality of
post-operative care.
Clinical Details
Official title: Periarticular Injection With Bupivacaine For Post-Operative Pain Control In Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Post operative pain
Secondary outcome: Complication of Morphine consumption
Detailed description:
Compare post operative pain control after total knee replacement by periarticular injection
with 0. 25% bupivacaine compare with 0. 9% normal saline.
Eligibility
Minimum age: 50 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- primary osteoarthritis patients undergoing total knee replacement at Siriraj Hospital
- BMI between 20-35
- having a full understanding of the question in this trial
Exclusion Criteria:
- allergy to NSAIDs, Acetaminophen, Bupivacaine
- blood creatinine more than 1. 5 mg/dl or creatinine clearance less than 60 mL/min
- abnormal liver function
- previous surgery on the knee undergoing total knee replacement
- patient could not receive spinal anesthesia
Locations and Contacts
Siriraj Hospital, Bangkoknoi, Bangkok 10700, Thailand
Additional Information
Total knee replacement FDA Resources on Drugs and Devices Bupivacaine information
Related publications: Mehrotra C, Remington PL, Naimi TS, Washington W, Miller R. Trends in total knee replacement surgeries and implications for public health, 1990-2000. Public Health Rep. 2005 May-Jun;120(3):278-82. Akyol O, Karayurt O, Salmond S. Experiences of pain and satisfaction with pain management in patients undergoing total knee replacement. Orthop Nurs. 2009 Mar-Apr;28(2):79-85. doi: 10.1097/NOR.0b013e3181945f62. Singelyn FJ, Deyaert M, Joris D, Pendeville E, Gouverneur JM. Effects of intravenous patient-controlled analgesia with morphine, continuous epidural analgesia, and continuous three-in-one block on postoperative pain and knee rehabilitation after unilateral total knee arthroplasty. Anesth Analg. 1998 Jul;87(1):88-92. Toftdahl K, Nikolajsen L, Haraldsted V, Madsen F, Tønnesen EK, Søballe K. Comparison of peri- and intraarticular analgesia with femoral nerve block after total knee arthroplasty: a randomized clinical trial. Acta Orthop. 2007 Apr;78(2):172-9. Vendittoli PA, Makinen P, Drolet P, Lavigne M, Fallaha M, Guertin MC, Varin F. A multimodal analgesia protocol for total knee arthroplasty. A randomized, controlled study. J Bone Joint Surg Am. 2006 Feb;88(2):282-9. Parvataneni HK, Shah VP, Howard H, Cole N, Ranawat AS, Ranawat CS. Controlling pain after total hip and knee arthroplasty using a multimodal protocol with local periarticular injections: a prospective randomized study. J Arthroplasty. 2007 Sep;22(6 Suppl 2):33-8. Epub 2007 Jul 26. Busch CA, Shore BJ, Bhandari R, Ganapathy S, MacDonald SJ, Bourne RB, Rorabeck CH, McCalden RW. Efficacy of periarticular multimodal drug injection in total knee arthroplasty. A randomized trial. J Bone Joint Surg Am. 2006 May;88(5):959-63.
Starting date: March 2010
Last updated: June 1, 2011
|