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

Phase 4

Withdrawn

• Conditions: Ankle Fracture in Need of Surgical Fixation
• Interventions: Drug: Ropivacaine block

• Registration Number: NCT01923623
• Lead Sponsor: Herlev Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-01
• Primary Completion: 2013-07-01
• Study Completion: 2013-07-31
• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-14
• Study First Posted: 2013-08-15
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-02
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Block	Ropivacaine block	Popliteal and saphenous Block with Ropivacaine
NaCl	Ropivacaine block	-

Primary Outcome Measures

Name	Time	Method
Use of Morphine	24 hours

Secondary Outcome Measures

Name	Time	Method
Functional rehabilitation outcome	10-14 weeks	American Orthopaedic Foot and Ankle Society (AOFAS) score