NCT01898052

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Oct 2012

Typical duration for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 2, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

July 9, 2013

Last Update Submit

March 31, 2014

Conditions

Postoperative Pain

Keywords

pain controlperiarticular injectionTotal knee arthroplastylevobupivacainemultimodal drug injection

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • time to request analgesic drug

    48 hours

Other Outcomes (2)

  • drug consumption

    48 hours

  • knee score

    3 months

Study Arms (2)

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

single anaesthetic drugDRUG

inject periarticular tissue of the knee after implantation

Also known as: levobupivacaine, chirocaine
Single anaesthetic drug
multimodal drug injectionDRUG

inject periarticular tissue of the knee

Also known as: anaesthetic cocktail
multimodal drug injection

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

department of orthopaedic surgery, Faculty of medicine, Thammasat university

Khlong Luang, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Supakit Kanitnate, M.D.

    orthopaedics department

    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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of orthopeadic surgery

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 12, 2013

Study Start

October 1, 2012

Primary Completion

February 1, 2014

Study Completion

March 1, 2014

Last Updated

April 2, 2014

Record last verified: 2014-03

Locations

TH(1)