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Comparison of fascia iliac compartment block with conventional sedation to facilitate the positioning of patients with fractured neck of femur for spinal anaesthesia and the effect of nerve blockade on postoperative pain and mobility. - FICB for patients with fractured NOF

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-001568-35-GB
Enrollment
100
Registered
2008-08-07
Start date
2008-06-24
Completion date
Unknown
Last updated
2012-07-24

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

Conditions

Investigation of the use a Fascia Iliaca nerve blockade for both positioning for spinal anaesthesia and postoperative analgesia in patients undergoing operative repair of fractured neck of femur.

Interventions

Trade Name: CHIROCAINE (0.25%) Pharmaceutical Form: Solution for injection Trade Name: LIDOCAINE 1% Pharmaceutical Form: Solution for injection Trade Name: HYPNOVEL Product Name: MIDAZOLAM Pharmaceu

Sponsors

BELFAST HEALTH & SOCIAL CARE TRUST
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: i) ASA class I-IV ii) Patient able to give written informed consent iii) Patients requiring operative repair of fractured neck of femur Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: i) History of dementia or difficulty in obtaining consent ii) History of allergy to any of the medications used in the study

Design outcomes

Primary

MeasureTime frame
Main Objective: The main objectives of the trial are firstly to evaluate the reduction in visual analogue scores (VAS) during positioning for spinal anaesthesia following the administration of either a fascia iliaca compartment block or a combination of iv midazolam and ketamine in patients undergoing operative repair of fractured neck of femur and secondly to evaluate the reduction in visual analogue scores (VAS) for pain at rest and with hip flexion after administration of either a single shot or bolus top-up compartment block in the postoperative period. ;Secondary Objective: 1. To assess the length of time to first request of additional analgesia 2. To evaluate the level of assistance required for transfer from the sitting to the standing position 3. To document the incidence and severity of motor blockade 4. To document the time taken to mobilisation with walking aid 5. Measurement of oxygen saturations without supplemental oxygen in both groups 6. To evaluate the incidence of all complications associated with the analgesic techniques in both groups. 7. To assess the incidence of nausea and/or vomiting within the first 48 hours after surgery in both groups 8. To assess the use of blood products in all groups 9. To determine the level of patient satisfaction with both techniques ;Primary end point(s): The reduction in VAS pain scores for both positioning for spinal anaesthesia and in the postoperative period for patients with fractured neck of femur

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026