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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Arthropathy of Knee Joint; Pain, Postoperative

Treatments: Drug: 0.9% normal saline; Drug: 0.25% Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01364194

516/2552(EC3)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

0.25% Bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: 0.25% Bupivacaine

0.9% normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.9% normal saline