Clinical trial NCT01364194: Local Infiltration With Bupivacaine to Increase Quality of Post-operative Pain Control in Total Knee Replacement
Official title: Periarticular Injection With Bupivacaine For Post-Operative Pain Control In Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Arthropathy of Knee Joint
Keywords: Post operative pain
Total knee replacement
Total knee arthroplasty
Bupivacaine
Periarticular injection
Placebo
Morphine consumption
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siriraj Hospital
First posted: 2011-06-02
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Post operative pain
timeFrame: 96 hour post operation
Secondary outcomes:
measure: Complication of Morphine consumption
timeFrame: 96 hour post operation
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Keerati Chareancholvanich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1177/003335490512000310.
citation: 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.
citation: 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. doi: 10.1097/00000539-199807000-00019.
citation: Toftdahl K, Nikolajsen L, Haraldsted V, Madsen F, Tonnesen EK, Soballe 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. doi: 10.1080/17453670710013645.
citation: 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. doi: 10.2106/JBJS.E.00173.
citation: 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. doi: 10.1016/j.arth.2007.03.034. Epub 2007 Jul 26.
citation: 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. doi: 10.2106/JBJS.E.00344.