Ankle Fracture in Need of Surgical Fixation Clinical Trial
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
| Verified date | April 2017 |
| Source | Herlev Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | July 31, 2013 |
| Est. primary completion date | July 1, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Herlev Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Use of Morphine | 24 hours | ||
| Secondary | Functional rehabilitation outcome | American Orthopaedic Foot and Ankle Society (AOFAS) score | 10-14 weeks |