The Effect of Nerve Blockades in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures.
Primary Purpose
Ankle Fracture in Need of Surgical Fixation
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ropivacaine block
Sponsored by
About this trial
This is an interventional supportive care trial for Ankle Fracture in Need of Surgical Fixation
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- Patients in need of anaesthesia for operative fixation of ankle fractures.
- American Society of Anesthesiologists (ASA) score 1-3.
- BMI > 18 og < 35.
- Oral and written consent
Exclusion Criteria:
- Weight < 50kg
- Allergy towards drugs used in the study
- Patients for re-operation
- Other fracture at the same time
- Pregnancy
- Daily use of opioids within two weeks before operation
- Infection near the application site
- Patients in need of dialysis
- Patients with neuropathy in lower extremities
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Block
NaCl
Arm Description
Popliteal and saphenous Block with Ropivacaine
Outcomes
Primary Outcome Measures
Use of Morphine
Secondary Outcome Measures
Functional rehabilitation outcome
American Orthopaedic Foot and Ankle Society (AOFAS) score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01923623
Brief Title
The Effect of Nerve Blockades in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures.
Official Title
The Effect of Combined Popliteal and Saphenous Block in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures: a Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Study was redesigned and taken over by a ph.D-student
Study Start Date
July 1, 2013 (Actual)
Primary Completion Date
July 1, 2013 (Actual)
Study Completion Date
July 31, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical, randomized, and controlled study will provide valuable scientific evidence regarding the effect of adding peripheral nerve blockades to general anaesthesia during ankle surgery. In particular, the investigators want to determine if the need for postoperative opioids will be reduced and whether this will lead to shorter admission to recovery room and fewer instances of side effects such as postoperative nausea and vomiting. In addition, the investigators will determine whether the functional outcome is improved i.e. faster and more successful rehabilitation. This would have profound benefits not only to the individual patient but also to society by reducing expenses during admission, the cost of sick leave etc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture in Need of Surgical Fixation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Block
Arm Type
Experimental
Arm Description
Popliteal and saphenous Block with Ropivacaine
Arm Title
NaCl
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ropivacaine block
Primary Outcome Measure Information:
Title
Use of Morphine
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Functional rehabilitation outcome
Description
American Orthopaedic Foot and Ankle Society (AOFAS) score
Time Frame
10-14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years
Patients in need of anaesthesia for operative fixation of ankle fractures.
American Society of Anesthesiologists (ASA) score 1-3.
BMI > 18 og < 35.
Oral and written consent
Exclusion Criteria:
Weight < 50kg
Allergy towards drugs used in the study
Patients for re-operation
Other fracture at the same time
Pregnancy
Daily use of opioids within two weeks before operation
Infection near the application site
Patients in need of dialysis
Patients with neuropathy in lower extremities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rune Sort, M.D.
Organizational Affiliation
Herlev Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann M. Møller, Dr.med.
Organizational Affiliation
Herlev Hospital
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
The Effect of Nerve Blockades in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures.
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