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

NCT ID: NCT01364194

Last Updated: 2011-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-09-30

Brief Summary

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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

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Compare post operative pain control after total knee replacement by periarticular injection with 0.25% bupivacaine compare with 0.9% normal saline.

Conditions

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Pain, Postoperative Arthropathy of Knee Joint

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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0.25% Bupivacaine

Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.

Group Type ACTIVE_COMPARATOR

0.25% Bupivacaine

Intervention Type DRUG

Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.

0.9% normal saline

Periarticular injection with 20 ml of 0.9% normal saline before wound closure.

Group Type PLACEBO_COMPARATOR

0.9% normal saline

Intervention Type DRUG

Periarticular injection with 20 ml of 0.9% normal saline before wound closure.

Interventions

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0.25% Bupivacaine

Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.

Intervention Type DRUG

0.9% normal saline

Periarticular injection with 20 ml of 0.9% normal saline before wound closure.

Intervention Type DRUG

Other Intervention Names

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Marcaine Isotonic saline

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siriraj Hospital

OTHER

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Siriraj Hospital, Mahidol University

Principal Investigators

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Keerati Chareancholvanich, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 16134568 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19339865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9661552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17464603 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16452738 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17823012 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16651569 (View on PubMed)

Related Links

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Other Identifiers

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516/2552(EC3)

Identifier Type: -

Identifier Source: org_study_id

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