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

Postoperative Pain Clinical Trial

— TKA  

Official title:

A Comparative Study on the Efficacy of Periarticular Single Anesthetic Drug Compared With Multimodal Drug Injection in Controlling Pain After Total Knee Arthroplasty: A Double Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898052
• Other study ID #: orthoTU03
• Secondary ID: orthoTU03
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2013
• Last updated: March 31, 2014
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Thammasat 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 determine the periarticular multimodal drug injection has more efficacy for controlling pain after TKA than single anaesthetic drug injection.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

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

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• single anaesthetic drug
inject periarticular tissue of the knee after implantation
• multimodal drug injection
inject periarticular tissue of the knee

Locations

Country	Name	City	State
Thailand	department of orthopaedic surgery, Faculty of medicine, Thammasat university	Khlong Luang	Pathumthani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	drug consumption	morphine consumption that record from patient controlled analgesia	48 hours	Yes
Other	knee score	Knee injury and osteoarthritis outcome score (KOOS) at pre-operation and post-operation 3 months	3 months	No
Primary	pain score	pain score at rest and activity between 2 groups every 4 hours until 48 hours after surgery	48 hour after surgery	No
Secondary	time to request analgesic drug	time when patient request morphine from patient controlled analgesia after intra-operative drug injection	48 hours	No