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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00968955
Other study ID # H-2-2009-079
Secondary ID 2009-41-3785
Status Completed
Phase Phase 4
First received August 28, 2009
Last updated September 28, 2011
Start date September 2009
Est. completion date June 2010

Study information

Verified date September 2011
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial 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.


Description:

In spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. We therefore decided to evaluate the effects of per-operative local infiltration analgesia with ropivacaine 0,2 % (150 ML) versus placebo on acute postoperative pain intensity in a well defined, multimodal, fast-track setup after hip arthroplasty. The technique is widely used as standard treatment in many European centers despite its limited evidence.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Elective total hip arthroplasty

- Able to speak and understand danish

- Able to give informed consent

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Hvidovre University Hospital Copenhagen Hvidover
Denmark Hørsholm Hospital Hørsholm

Sponsors (2)

Lead Sponsor Collaborator
Hvidovre University Hospital Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain scores on the Visual Analog Scale (during walking) up to 8 hours No
Secondary Additional analgetics measured as cumulated amount i mg up to 8 hours No
Secondary Time spend in hospital measured as nights after surgery At discharge (mean 2-3 nights) No
Secondary Number of Participants with Adverse Events as a Measure of Safety and Tolerability up to 8 hours Yes
Secondary Postoperative pain scores on the Visual Analog Scale (at rest) up to 8 hour No
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