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Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type

This study has been completed.
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01119209
First received: May 4, 2010
Last updated: March 15, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention Phase
Hip Fracture of Intertrochanteric Type
 Drug: Ropivacaine
Drug: Saline
 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: Treatment
Official Title: Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Consumption of opioids [ Time Frame: 5 days postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: 5 days postoperatively ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: February 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: May 4, 2010
Last Updated: March 15, 2011
Health Authority: Denmark: Danish Medicines Agency

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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013