The Efficacy of Periarticular Single Drug Compared With Multimodal Drug Injection in Controlling Pain After TKA

Thammasat University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: single anaesthetic drug; Drug: multimodal drug injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01898052

orthoTU03 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the periarticular multimodal drug injection has more efficacy for controlling pain after TKA than single anaesthetic drug injection.

Full description

Many studies have to determine the efficacy of periarticular multimodal drug injection or single local anaesthetic drug comparing with placebo for pain controlled in TKA. But in this study would like to determine which one of both drugs are more efficacy.

In multimodal drug injection consist of levobupivacaine, morphine, ketorolac and epinephrine while single anaesthetic drug has levobupivacaine and epinephrine.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primary osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
• age 50-85 years old

Exclusion criteria

• unable to perform spinal anaesthesia
• history of drug allergies; local anaesthesia, Non-steroidal anti-inflammatory drugs, morphine, epinephrine
• cognitive function impairment
• renal impairment (creatinine clearance < 30 mL/min)
• liver impairment, gastrointestinal bleeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups

multimodal drug injection

Experimental group

Description:

Multimodal drug injection Levobupivacaine 150 mg, epinephrine(1:1000) 0.6 mL(0.6 mg), morphine sulfate 5 mL(5 mg), ketorolac 1 mL (30 mg) and mixed with normal saline up to 100 mL

Treatment:

Drug: multimodal drug injection

Single anaesthetic drug

Active Comparator group

Description:

Single anaesthetic drug levobupivacaine 150 mg and epinephrine (1:1000) 0.6 ml (0.6 mg)

Treatment:

Drug: single anaesthetic drug