The Effect of Nerve Blockades in Addition to General Anesthesia in Surgical Fixation of Ankle Fractures.

Herlev Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Ankle Fracture in Need of Surgical Fixation

Treatments: Drug: Ropivacaine block

Study type: Interventional

Funder types: Other

Identifiers

NCT01923623

Huggi123

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Block

Experimental group

Description:

Popliteal and saphenous Block with Ropivacaine

Treatment:

Drug: Ropivacaine block

NaCl

Placebo Comparator group

Treatment:

Drug: Ropivacaine block