The Efficacy of Periarticular Single Drug Compared With M... | NCT01898052

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

NCT01898052

Sponsor

Thammasat University

Status

Completed

Last Update Posted

Apr 2, 2014Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Postoperative Pain

Interventions

single anaesthetic drug
multimodal drug injection

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
orthoTU03	Other Identifier	Tha

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Feb 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Jul 9, 2013

First Submission Date that Met QC Criteria

Jul 11, 2013

First Posted Date

Jul 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2014

Last Update Posted Date

Apr 2, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
multimodal drug injection	Experimental	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	Drug: multimodal drug injection
Single anaesthetic drug	Active Comparator	Single anaesthetic drug levobupivacaine 150 mg and epinephrine (1:1000) 0.6 ml (0.6 mg)	Drug: single anaesthetic drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
single anaesthetic drug	Drug	inject periarticular tissue of the knee after implantation	Single anaesthetic drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain score	pain score at rest and activity between 2 groups every 4 hours until 48 hours after surgery	48 hour after surgery

Secondary Outcomes

Measure	Description	Time Frame
time to request analgesic drug	time when patient request morphine from patient controlled analgesia after intra-operative drug injection	48 hours

Other Outcomes

Measure	Description	Time Frame
drug consumption	morphine consumption that record from patient controlled analgesia	48 hours
knee score	Knee injury and osteoarthritis outcome score (KOOS) at pre-operation and post-operation 3 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Supakit Kanitnate, M.D.	orthopaedics department	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
department of orthopaedic surgery, Faculty of medicine, Thammasat university		Khlong Luang	Changwat Pathum Thani	12120	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D000377	Agnosia

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077554	Levobupivacaine

Ancestor Terms

ID	Term
D002045	Bupivacaine
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided