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

NCT01364194 | Completed Phase 4 DMC

• 1 other identifier: 516/2552(EC3)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Arthropathy of Knee Joint

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Post operative pain

  Measure by Visual analog scale scores and morphine consumption

  96 hour post operation

Secondary Outcomes (1)

• Complication of Morphine consumption

  96 hour post operation

Study Arms (2)

0.25% Bupivacaine

ACTIVE COMPARATOR

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

Drug: 0.25% Bupivacaine

0.9% normal saline

PLACEBO COMPARATOR

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

Drug: 0.9% normal saline

Interventions

0.25% Bupivacaine DRUG

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

Also known as: Marcaine

0.25% Bupivacaine

0.9% normal saline DRUG

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

Also known as: Isotonic saline

0.9% normal saline

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary osteoarthritis patients undergoing total knee replacement at Siriraj Hospital
• BMI between 20-35
• having a full understanding of the question in this trial

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• Siriraj Hospital: collaborator

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (7)

• 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.

  PMID: 16134568 BACKGROUND

• 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.

  PMID: 19339865 BACKGROUND

• 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.

  PMID: 9661552 BACKGROUND

• 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.

  PMID: 17464603 BACKGROUND

• 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.

  PMID: 16452738 BACKGROUND

• 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.

  PMID: 17823012 BACKGROUND

• 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.

  PMID: 16651569 BACKGROUND

Related Links

• Total knee replacement
• Bupivacaine information

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Keerati Chareancholvanich, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 31, 2011
• First Posted: June 2, 2011
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 2, 2011

Record last verified: 2011-05

Locations

TH (1)