NCT00864409

Brief Summary

High-volume infiltration analgesia may be effective in postoperative pain management following total hip arthroplasty. In this randomized, double-blind trial patients undergoing bilateral hip arthoplasty are randomized to receive high-volume local anesthetic infiltration in one hip and similar infiltration with saline (placebo) in the other hip.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
Last Updated

March 18, 2009

Status Verified

March 1, 2009

First QC Date

March 17, 2009

Last Update Submit

March 17, 2009

Conditions

Postoperative PainHip Arthroplasty

Keywords

postoperative paintotal hip arthroplasty

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    0-48 hours postoperative

Study Arms (2)

Hip 1

ACTIVE COMPARATOR

high volume local anesthetic infiltration

Drug: ropivacaine 0,2%

Hip 2

PLACEBO COMPARATOR
Drug: saline.9%

Interventions

ropivacaine 0,2%DRUG

Local wound infiltrtation with 170 mL ropivacaine 2 mg/mL

Hip 1
saline.9%DRUG

Wound infiltration with 170 mL sterile saline

Hip 2

Eligibility Criteria

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

You may qualify if:

  • scheduled for bilateral total hip arthroplasty
  • able to speak and understand Danish

You may not qualify if:

  • treatment with opioids or steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hviovre University Hospital

Hvidovre, DK-2650, Denmark

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Lasse Andersen, MD

CONTACT

+45 36323632lasse.oestergaard.andersen@hvh.regionh.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Last Updated

March 18, 2009

Record last verified: 2009-03

Locations

DK(1)