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Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type

Primary Purpose

Hip Fracture of Intertrochanteric Type

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
Saline
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Fracture of Intertrochanteric Type focused on measuring Hip fracture, intertrochanteric

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Ropivacaine

Saline

Arm Description

Outcomes

Primary Outcome Measures

Consumption of opioids

Secondary Outcome Measures

Pain

Full Information

First Posted
May 4, 2010
Last Updated
March 15, 2011
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01119209
Brief Title
Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type
Official Title
Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Odense University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fracture of Intertrochanteric Type
Keywords
Hip fracture, intertrochanteric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ropivacaine
Arm Type
Active Comparator
Arm Title
Saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Approved by the Danish Medicines Agency
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Approved by the Danish Medicines Agency
Primary Outcome Measure Information:
Title
Consumption of opioids
Time Frame
5 days postoperatively
Secondary Outcome Measure Information:
Title
Pain
Time Frame
5 days postoperatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soren Overgaard, MD, DmSc
Organizational Affiliation
Odense University Hospital, DK-5000 Odense C, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rune Dueholm Bech, MD
Organizational Affiliation
Odense University Hospital, DK-5000 Odense C, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
DK
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
30538796
Citation
Bech RD, Ovesen O, Lauritsen J, Emmeluth C, Lindholm P, Overgaard S. Local Anesthetic Wound Infiltration after Osteosynthesis of Extracapsular Hip Fracture Does Not Reduce Pain or Opioid Requirements: A Randomized, Placebo-Controlled, Double-Blind Clinical Trial in 49 Patients. Pain Res Manag. 2018 Nov 13;2018:6398424. doi: 10.1155/2018/6398424. eCollection 2018.
Results Reference
derived

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Postoperative Analgesia With Local Infiltration After Hip Fracture Of Intertrochanteric Type

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