Ankle Fracture in Need of Surgical FixationPhase 4NCT01923623
The Effect of Nerve Blockades in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures.
A Phase 4 study testing Ropivacaine block in people with Ankle Fracture in Need of Surgical Fixation, run by Herlev Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fracture in Need of Surgical Fixation
- What is being tested?
- Ropivacaine block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2013to 31 Jul 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Infection near the application site
- Patients in need of dialysis
- Patients with neuropathy in lower extremities
About this study
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
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.
- Being tested
- Ropivacaine block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine blockDrug
| Study group | Role | What they receive |
|---|---|---|
| Block | Experimental | Popliteal and saphenous Block with Ropivacaine Receives: Drug: Ropivacaine block |
| NaCl | Placebo comparator | Not described Receives: Drug: Ropivacaine block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Morphine
Measured: 24 hours
Secondary outcomes (1)
Functional rehabilitation outcome
American Orthopaedic Foot and Ankle Society (AOFAS) score
Measured: 10-14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study start1 Jul 2013
- Primary completion1 Jul 2013
- Study completion31 Jul 2013
Why it stopped: Study was redesigned and taken over by a ph.D-student
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Fracture in Need of Surgical FixationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Kruse, Herlev Hospital
- Investigators
- Rune Sort, M.D., Principal investigator, Herlev HospitalAnn M. Møller, Dr.med., Study director, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923623
- Sponsor's protocol ID
- Huggi123
- Status last verified
- Apr 2017
- First submitted
- 13 Aug 2013
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01923623
- Acronym / sponsor ID
- Huggi123
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was redesigned and taken over by a ph.D-student
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 1 Jul 2013 (actual)
- Study completion
- 31 Jul 2013 (actual)
- First posted
- 15 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block | Experimental | Drug: Ropivacaine blockPopliteal and saphenous Block with Ropivacaine |
| NaCl | Placebo comparator | Drug: Ropivacaine block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Weight < 50kg
- Allergy towards drugs used in the study
- Patients for re-operation
- Other fracture at the same time
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine block | Drug | Block, NaCl |
Primary outcome
Use of Morphine
Time frame: 24 hours
1 secondary outcome
Functional rehabilitation outcome
Time frame: 10-14 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rune Sort, M.D. principal investigator
Herlev Hospital
Ann M. Møller, Dr.med. study director
Herlev Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine block in people with Ankle Fracture in Need of Surgical Fixation, run by Herlev Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Morphine (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.