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

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.

Study Overview

• Status: Withdrawn
• Conditions: Ankle Fracture in Need of Surgical Fixation
• Intervention / Treatment: Drug: Ropivacaine block

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: NaCl	Drug: Ropivacaine block
Experimental: Block; Popliteal and saphenous Block with Ropivacaine	Drug: Ropivacaine block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Use of Morphine	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional rehabilitation outcome	American Orthopaedic Foot and Ankle Society (AOFAS) score	10-14 weeks

Collaborators and Investigators

• Sponsor: Herlev Hospital
• Investigators: Principal Investigator: Rune Sort, M.D., Herlev Hospital; Study Director: Ann M. Møller, Dr.med., Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 31, 2013

Study Registration Dates

• First Submitted: August 13, 2013
• First Submitted That Met QC Criteria: August 14, 2013
• First Posted (Estimate): August 15, 2013

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: April 2, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Ankle Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: Huggi123