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

NCT ID: NCT01923623

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-01
• Study Completion Date: 2013-07-31

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.

Conditions

Ankle Fracture in Need of Surgical Fixation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Block

Popliteal and saphenous Block with Ropivacaine

Group Type: EXPERIMENTAL

Ropivacaine block

Intervention Type: DRUG

NaCl

Group Type: PLACEBO_COMPARATOR

Ropivacaine block

Intervention Type: DRUG

Interventions

Ropivacaine block

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: lead

Responsible Party

Heidi Kruse

Pregraduat research assistent

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rune Sort, M.D.

Role: PRINCIPAL_INVESTIGATOR

Herlev Hospital

Ann M. Møller, Dr.med.

Role: STUDY_DIRECTOR

Herlev Hospital

Other Identifiers

Huggi123

Identifier Type: -

Identifier Source: org_study_id