NCT00968955

Brief Summary

The purpose of the study is to compare the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity after total hip arthroplasty. The hypothesis is that local infiltration analgesia reduces the acute postoperative pain intensity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

9 months

First QC Date

August 28, 2009

Last Update Submit

September 28, 2011

Conditions

Post-operative Pain

Keywords

Postoperative acute painTotal hip arthroplastyLocal infiltration analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain scores on the Visual Analog Scale (during walking)

    up to 8 hours

Secondary Outcomes (4)

  • Additional analgetics measured as cumulated amount i mg

    up to 8 hours

  • Time spend in hospital measured as nights after surgery

    At discharge (mean 2-3 nights)

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    up to 8 hours

  • Postoperative pain scores on the Visual Analog Scale (at rest)

    up to 8 hour

Study Arms (2)

Local infiltration with ropivacaine

ACTIVE COMPARATOR

Local infiltration with ropivacaine 0,2% (150 ML)

Drug: Ropivacaine

Local infiltration with saline

PLACEBO COMPARATOR

Local infiltration with saline (150 ML) (placebo)

Drug: Ropivacaine

Interventions

RopivacaineDRUG

Local infiltration with ropivacaine 0,2% (150 ML)

Local infiltration with ropivacaineLocal infiltration with saline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective total hip arthroplasty
  • Able to speak and understand danish
  • Able to give informed consent

You may not qualify if:

  • Alcohol or medical abuse
  • Allergies to local anesthetics
  • Age \< 18 years
  • Daily use of opioids or glucocorticoids
  • Pregnancy or breastfeeding
  • Opioid intolerance
  • Obesity defined as BMI\>40 kg/m2
  • Diabetic neuropathy and rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hvidovre University Hospital

Copenhagen, Hvidover, 2650, Denmark

Location

Hørsholm Hospital

Hørsholm, Hørsholm, 2970, 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
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

DK(2)