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Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-operative Pain focused on measuring Postoperative acute pain, Total hip arthroplasty, Local infiltration analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hvidovre University Hospital
  • Hørsholm Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Local infiltration with ropivacaine

Local infiltration with saline

Arm Description

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

Local infiltration with saline (150 ML) (placebo)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Additional analgetics measured as cumulated amount i mg
Time spend in hospital measured as nights after surgery
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Postoperative pain scores on the Visual Analog Scale (at rest)

Full Information

First Posted
August 28, 2009
Last Updated
September 28, 2011
Sponsor
Hvidovre University Hospital
Collaborators
Lundbeck Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00968955
Brief Title
Effect of Local Infiltration Analgesia in Total Hip Arthroplasty
Official Title
Effect of Local Infiltration Analgesia With Ropivacaine in Total Hip Arthroplasty: a Prospective, Randomized, Double-blind, Placebo-controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hvidovre University Hospital
Collaborators
Lundbeck Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
Postoperative acute pain, Total hip arthroplasty, Local infiltration analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local infiltration with ropivacaine
Arm Type
Active Comparator
Arm Description
Local infiltration with ropivacaine 0,2% (150 ML)
Arm Title
Local infiltration with saline
Arm Type
Placebo Comparator
Arm Description
Local infiltration with saline (150 ML) (placebo)
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Local infiltration with ropivacaine 0,2% (150 ML)
Primary Outcome Measure Information:
Title
Postoperative pain scores on the Visual Analog Scale (during walking)
Time Frame
up to 8 hours
Secondary Outcome Measure Information:
Title
Additional analgetics measured as cumulated amount i mg
Time Frame
up to 8 hours
Title
Time spend in hospital measured as nights after surgery
Time Frame
At discharge (mean 2-3 nights)
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
up to 8 hours
Title
Postoperative pain scores on the Visual Analog Scale (at rest)
Time Frame
up to 8 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hvidovre University Hospital
City
Copenhagen
State/Province
Hvidover
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Hørsholm Hospital
City
Hørsholm
ZIP/Postal Code
2970
Country
Denmark

12. IPD Sharing Statement

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Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

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