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NCT00529425 Clinical Trial

Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture

Femoral Neck Fracture Clinical Trial

Official title:
Postoperative Analgesia With Local Infiltration After Femoral Neck Fracture vs. Traditional Treatment of Pain With Opioids

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00529425
Other study ID # S-VF-20060072 - femoral neck
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2007
Last updated May 5, 2010
Start date January 2008
Est. completion date December 2008

Study information
Verified date April 2010
Source Odense University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

Reducing pain is an essential factor for early mobilization after osteosynthesis of femoral neck fractures. Systemic opioids have side effects that might obstruct mobilization and induce delirium and nausea. The investigators hypothesized that wound infiltration results in reduction in systemic opioid usage and pain relief without side effects.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Femoral neck fracture

- Fracture due to low energy trauma

- Ability to understand danish and give informed consent

- Ability to walk before trauma

- Indication for osteosynthesis

- = 8 in OMC (Orientation-Memory-Concentration) test with a possible maximum of 28 points

- Informed consent

Exclusion Criteria:

- Drug or medical abuse

- Drug intolerance

- Pathological fractures

- Inflammatory arthritis

- Patient included in the study with the contralateral hip

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Ropivacaine

Locations
Country Name City State
Denmark Odense University Hospital Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Consumption of opioids
Secondary Pain
See also
  Status Clinical Trial Phase
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Withdrawn NCT02202122 - Interest of the OSA (Obstructive Sleep Apnea) Predictive Scores in the Prognosis of Postoperative Mortality of Femoral Neck Fractures N/A
Terminated NCT01219062 - Postoperative Pain Control After Hip Hemiarthroplasty: Intrathecal Morphine vs Periarticular Infiltration of Bupivacaine Phase 4
Active, not recruiting NCT02362971 - External Validity of a Randomized Trial in Patients With a Femoral Neck Fracture N/A
Completed NCT02591342 - Comparison of a Cemented, Polished Tapered Stem and an Anatomic Stem for Femoral Neck Fracture N/A
Recruiting NCT05171140 - Influence of the Spatial Distribution of Hollow Screws on the Blood Supply and Prognosis of Femoral Neck Fractures N/A
Completed NCT02433548 - Fascia Iliaca Block in the Emergency Department for Analgesia After Femoral Neck Fracture Phase 4
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Recruiting NCT03550079 - Fixation for the Treatment of Femoral Neck Fractures N/A
Completed NCT04879472 - Early Functional Outcome of Operative Treatment of Displaced Femoral Neck Fractures in Two Kenyan Orthopaedic Centres
Completed NCT00913679 - A Comparison of Two Different Surgical Techniques in Hip Resurfacing Arthroplasty N/A
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Recruiting NCT01112436 - The Effect of Periarticular Multi-Drug Regimen on Pain After Partial Hip Replacement Phase 4
Completed NCT01052974 - Perioperative Analgesia by Femoral Perineural Catheter for Femoral Neck Fracture - Study KTcol Phase 4
Terminated NCT02030431 - Dynaloc for Treatment of Femoral Neck Fractures N/A
Completed NCT01114646 - Functional Status, Morbidity and Mortality in Cemented Versus Press-Fit Hemiarthroplasty N/A
Completed NCT02512094 - Validity and Reliability of Thai Version of Barthel Index for Hip Fracture Patients N/A
Recruiting NCT02148848 - Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty Phase 4
Completed NCT01644227 - Dual Mobility Cup in Total Hip Arthroplasty Preventing Dislocation in Patients at Risk N/A
Active, not recruiting NCT02901938 - Feasibility of Implantation of Cemented Femoral Stem for Osteoporotic Femoral Neck Fracture in Elderly Patients N/A