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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01923623

Enrollment

Registered

2013-08-15

Start date

2013-07-01

Completion date

2013-07-31

Last updated

2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Fracture in Need of Surgical Fixation

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.

Interventions

DRUGRopivacaine block

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Use of Morphine	24 hours

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026