Effect of Local Infiltration Analgesia in Total Hip Arthroplasty

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00968955

Enrollment

120

Registered

2009-08-31

Start date

2009-09-30

Completion date

2010-06-30

Last updated

2011-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Pain

Keywords

Postoperative acute pain, Total hip arthroplasty, Local infiltration analgesia

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.

Interventions

DRUGRopivacaine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Postoperative pain scores on the Visual Analog Scale (during walking)	up to 8 hours

Secondary

Measure	Time frame
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026