Local Infiltration With Bupivacaine to Increase Quality of Post-operative Pain Control in Total Knee Replacement - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pain, Postoperative Arthropathy of Knee Joint	Drug: 0.25% Bupivacaine Drug: 0.9% normal saline	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Periarticular Injection With Bupivacaine For Post-Operative Pain Control In Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Joint Disorders Knee Replacement

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:

Post operative pain [ Time Frame: 96 hour post operation ] [ Designated as safety issue: No ]
Measure by Visual analog scale scores and morphine consumption

Secondary Outcome Measures:

Complication of Morphine consumption [ Time Frame: 96 hour post operation ] [ Designated as safety issue: No ]
nausea, pruritis, urinary retention and constipation

Enrollment:	60
Study Start Date:	March 2010
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 0.25% Bupivacaine Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.	Drug: 0.25% Bupivacaine Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure. Other Name: Marcaine
Placebo Comparator: 0.9% normal saline Periarticular injection with 20 ml of 0.9% normal saline before wound closure.	Drug: 0.9% normal saline Periarticular injection with 20 ml of 0.9% normal saline before wound closure. Other Name: Isotonic saline

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

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364194

Locations

Thailand
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700

Sponsors and Collaborators

Mahidol University

Siriraj Hospital

Investigators

Principal Investigator:

Keerati Chareancholvanich, MD

Siriraj Hospital

More Information

Additional Information:

Total knee replacement This link exits the ClinicalTrials.gov site

FDA Resources on Drugs and Devices This link exits the ClinicalTrials.gov site

Bupivacaine information This link exits the ClinicalTrials.gov site

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.

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.

Responsible Party:	Keerati Chareancholvanich, MD, Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier:	NCT01364194 History of Changes
Other Study ID Numbers:	516/2552(EC3)
Study First Received:	May 31, 2011
Last Updated:	June 1, 2011
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

Post operative pain
Total knee replacement
Total knee arthroplasty
Bupivacaine

Periarticular injection
Placebo
Morphine consumption

Additional relevant MeSH terms:

Joint Diseases
Pain, Postoperative
Musculoskeletal Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local

Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013