NCT01012232

Brief Summary

In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high concentration (10 mL, 10 mg/mL) 6 and 24 hours postoperatively, and pain will be assessed at rest and with mobilization for 2 hours after injections.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at below P25 for phase_4 postoperative-pain

Timeline
Completed

Started Jun 2009

Shorter than P25 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

June 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
Last Updated

November 11, 2009

Status Verified

November 1, 2009

Enrollment Period

4 months

First QC Date

November 10, 2009

Last Update Submit

November 10, 2009

Conditions

Postoperative PainAnalgesic Efficacy

Keywords

total knee arthroplastypostoperative pain

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    32 hours postoperative

Study Arms (2)

low volume local anesthetic

ACTIVE COMPARATOR

bolus injection of local anesthetic in low volume/high concentration (10 mL, 10 mg/mL)

Drug: 10 mL ropivacaine 10 mg/mL

high volume local anesthetic

EXPERIMENTAL

bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL)

Drug: 20 mL ropivacaine 5 mg/mL

Interventions

20 mL ropivacaine 5 mg/mLDRUG
high volume local anesthetic
10 mL ropivacaine 10 mg/mLDRUG
low volume local anesthetic

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for total knee arthroplasty
  • Able to give informed oral and written consent to participate

You may not qualify if:

  • Treatment with opioids or steroids, rheumatoid arthritis or other immunological diseases
  • History of stroke or any neurological or psychiatric disease potentially influencing pain perception (e.g. depression, diabetic neuropathy etc.)
  • Allergies to any of the drugs administered.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lundbeck Centre for fast-track hip and knee arthroplasty

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

June 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 11, 2009

Record last verified: 2009-11

Locations

DK(1)