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Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type

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ClinicalTrials.gov Identifier: NCT01119209
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : March 16, 2011
Sponsor:
Information provided by:
Odense University Hospital

Brief Summary:
Reducing pain is an essential factor for early mobilization after osteosynthesis of intertrochanteric 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.

Condition or disease Intervention/treatment Phase
Hip Fracture of Intertrochanteric Type Drug: Ropivacaine Drug: Saline Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type
Study Start Date : February 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ropivacaine Drug: Ropivacaine
Approved by the Danish Medicines Agency

Drug: Saline
Approved by the Danish Medicines Agency

Placebo Comparator: Saline Drug: Saline
Approved by the Danish Medicines Agency




Primary Outcome Measures :
  1. Consumption of opioids [ Time Frame: 5 days postoperatively ]

Secondary Outcome Measures :
  1. Pain [ Time Frame: 5 days postoperatively ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intertrochanteric hip 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119209


Locations
Denmark
Odense University Hospital
Odense, DK, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Investigators
Study Chair: Soren Overgaard, MD, DmSc Odense University Hospital, DK-5000 Odense C, Denmark
Principal Investigator: Rune Dueholm Bech, MD Odense University Hospital, DK-5000 Odense C, Denmark

Responsible Party: Rune Dueholm Bech, MD, Odense University Hospital, DK-5000 Odense C, Denmark
ClinicalTrials.gov Identifier: NCT01119209     History of Changes
Other Study ID Numbers: S-VF-20060072 - trochanteric
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011

Keywords provided by Odense University Hospital:
Hip fracture
intertrochanteric

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents