Study of monitoring blood concentration of local anaesthetic after a nerve block in elderly patients with hip fracture

Not Applicable

Completed

• Conditions: Specialty: Anaesthesia, perioperative medicine and pain management, Primary sub-specialty: Anaesthesia, Perioperative Medicine and Pain Management; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the hip and thigh; Surgery; Fascia Iliaca Compartment Block (FICB)

• Registration Number: ISRCTN27364035
• Lead Sponsor: Surrey and Sussex Healthcare NHS Trust

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30924096 [added 03/05/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-21
• Study Completion: 2017-11-01
• Last Update Posted: 29 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

1. Informed consent: signed written informed consent before inclusion in the study
2. Radiologically-confirmed fractured neck of femur
3. Age 80 years and over
4. Scheduled to receive fascia iliaca compartment block (to be done by anaesthetic team, as per standard local care protocol)

Exclusion Criteria

1. Patient refusal or incapacity
2. Patient on anticoagulation medication
3. INR > 3.0
4. Platelets < 50
5. Allergy or contraindication to local anaesthetics
6. Local infection to site of FICB injection or blood sampling
7. Creatinine >300 or receiving renal replacement therapy or dialysis
8. Patients requiring Level 2 or 3 care
9. Estimated weight < 40kg or > 120kg

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profile of levobupivacaine is measured through blood testing on samples taken at baseline and 10, 20, 30, 45, 60, 75, 90, 105, 120, 240 minutes after the FICB.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Relationship between time and pain after fascia iliaca compartment block is measured through blood testing and visual analogue scale (VAS) on samples taken at baseline and 10, 20, 30, 45, 60, 75, 90, 105, 120, 240 minutes after the FICB<br> 2. Range of alpha-1 glycoprotein plasma concentration in elderly patients with hip fracture is measured through blood testing on samples taken at baseline and 10, 20, 30, 45, 60, 75, 90, 105, 120, 240 minutes after the FICB<br> 3. Patient demographics, renal function, intravenous fluid administration, supplemental analgesia requirements are measured using medical record review at baseline<br>