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

Primary Purpose

Pain, Postoperative, Arthropathy of Knee Joint

Status

Completed

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

0.25% Bupivacaine

0.9% normal saline

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Post operative pain, Total knee replacement, Total knee arthroplasty, Bupivacaine, Periarticular injection, Placebo, Morphine consumption

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Siriraj Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

0.25% Bupivacaine

0.9% normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Post operative pain

Measure by Visual analog scale scores and morphine consumption

Secondary Outcome Measures

Complication of Morphine consumption

nausea, pruritis, urinary retention and constipation

Full Information

NCT ID

NCT01364194

First Posted

May 31, 2011

Last Updated

June 1, 2011

Sponsor

Mahidol University

Collaborators

Siriraj Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01364194

Brief Title

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

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mahidol University

Collaborators

Siriraj Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Arthropathy of Knee Joint

Keywords

Post operative pain, Total knee replacement, Total knee arthroplasty, Bupivacaine, Periarticular injection, Placebo, Morphine consumption

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.25% Bupivacaine

Arm Type

Active Comparator

Arm Description

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

Arm Title

0.9% normal saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

0.25% Bupivacaine

Other Intervention Name(s)

Marcaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

0.9% normal saline

Other Intervention Name(s)

Isotonic saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Post operative pain

Description

Measure by Visual analog scale scores and morphine consumption

Time Frame

96 hour post operation

Secondary Outcome Measure Information:

Title

Complication of Morphine consumption

Description

nausea, pruritis, urinary retention and constipation

Time Frame

96 hour post operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Keerati Chareancholvanich, MD

Organizational Affiliation

Siriraj Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

16134568

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.

Results Reference

background

PubMed Identifier

19339865

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.

Results Reference

background

PubMed Identifier

9661552

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.

Results Reference

background

PubMed Identifier

17464603

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.

Results Reference

background

PubMed Identifier

16452738

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.

Results Reference

background

PubMed Identifier

17823012

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.

Results Reference

background

PubMed Identifier

16651569

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.

Results Reference

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Links:

URL

http://www.nlm.nih.gov/medlineplus/kneereplacement.html

Description

Total knee replacement

URL

http://www.rxlist.com/marcaine-drug.htm

Description

Bupivacaine information

Learn more about this trial

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

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