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

Pain, Postoperative Clinical Trial

Official title:

Periarticular Injection With Bupivacaine For Post-Operative Pain Control In Total Knee Replacement: A Prospective Randomized Double-Blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364194
• Other study ID #: 516/2552(EC3)
• Status: Completed
• Phase: Phase 4
• First received: May 31, 2011
• Last updated: June 1, 2011
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: May 2011
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthropathy of Knee Joint
• Pain, Postoperative

Intervention

Drug:
• 0.25% Bupivacaine
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.

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	Siriraj Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

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. — View 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. — View 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. — View 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. Epub 2007 Jul 26. — View 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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain	Measure by Visual analog scale scores and morphine consumption	96 hour post operation	No
Secondary	Complication of Morphine consumption	nausea, pruritis, urinary retention and constipation	96 hour post operation	No

External Links

•   Bupivacaine information
•   FDA Resources on Drugs and Devices
•   Total knee replacement