NCT00921908

Brief Summary

Postoperative administration of local anesthetics is effective for postoperative pain management across surgical specialties but the optimal type of catheter (single, few or multiholed catheters) has not been determined. This study investigates wound spread of a radioactive isotope (technetium) administered in different types of catheters after total hip arthroplasty.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
Last Updated

June 17, 2009

Status Verified

June 1, 2009

Enrollment Period

8 months

First QC Date

June 16, 2009

Last Update Submit

June 16, 2009

Conditions

Postoperative PainHip Arthroplasty

Keywords

total hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • wound spread area of radioactive isotope

Study Arms (2)

epidural catheter

subfascial placement of a triple-orifice epidural catheter

Other: 2 mBq radioactive technetium diluted in 20 mL saline

multiholed catheter

subfascial placement of a multi-orifice 15 cm catheter

Other: 2 mBq radioactive technetium diluted in 20 mL saline

Interventions

2 mBq radioactive technetium diluted in 20 mL salineOTHER
epidural cathetermultiholed catheter

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients undergoing total hip arthoplasty

You may qualify if:

  • operation with total hip arthroplasty

You may not qualify if:

  • allergies to drugs administered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 17, 2009

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 17, 2009

Record last verified: 2009-06

Locations

DK(1)