Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

Post-operative Pain Clinical Trial

Official title:

Effect of Local Infiltration Analgesia With Ropivacaine in Total Hip Arthroplasty: a Prospective, Randomized, Double-blind, Placebo-controlled Trail

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

• Pain, Postoperative
• Post-operative Pain

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