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Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Troels Haxholdt Lunn, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00968955
First received: August 28, 2009
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Post-operative Pain
 Drug: Ropivacaine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effect of Local Infiltration Analgesia With Ropivacaine in Total Hip Arthroplasty: a Prospective, Randomized, Double-blind, Placebo-controlled Trail

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Postoperative pain scores on the Visual Analog Scale (during walking) [ Time Frame: up to 8 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional analgetics measured as cumulated amount i mg [ Time Frame: up to 8 hours ] [ Designated as safety issue: No ]
  • Time spend in hospital measured as nights after surgery [ Time Frame: At discharge (mean 2-3 nights) ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: up to 8 hours ] [ Designated as safety issue: Yes ]
  • Postoperative pain scores on the Visual Analog Scale (at rest) [ Time Frame: up to 8 hour ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Local infiltration with ropivacaine
Local infiltration with ropivacaine 0,2% (150 ML)
 Drug: Ropivacaine
Local infiltration with ropivacaine 0,2% (150 ML)
Placebo Comparator: Local infiltration with saline
Local infiltration with saline (150 ML) (placebo)
 Drug: Ropivacaine
Local infiltration with ropivacaine 0,2% (150 ML)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00968955

Locations
Denmark
Hvidovre University Hospital
Copenhagen, Hvidover, Denmark, 2650
Hørsholm Hospital
Hørsholm, Denmark, 2970
Sponsors and Collaborators
Hvidovre University Hospital
Lundbeck Foundation
  More Information

No publications provided

Responsible Party: Troels Haxholdt Lunn, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT00968955     History of Changes
Other Study ID Numbers: H-2-2009-079, 2009-41-3785
Study First Received: August 28, 2009
Last Updated: September 28, 2011
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Hvidovre University Hospital:
Postoperative acute pain
Total hip arthroplasty
Local infiltration analgesia

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013