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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 6 February 2017
Main ID:  ISRCTN27364035
Date of registration: 21/12/2016
Prospective Registration: Yes
Primary sponsor: Surrey and Sussex Healthcare NHS Trust
Public title: Study of monitoring blood concentration of local anaesthetic after a nerve block in elderly patients with hip fracture
Scientific title: Pilot study of a plasma local anaesthetic monitoring regime after fascia iliaca block in elderly patients
Date of first enrolment: 14/11/2016
Target sample size: 8
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN27364035
Study type:  Interventional
Study design:  Non-randomised; Interventional; Design type: Process of Care, Management of Care (Treatment)  
Phase: 
Countries of recruitment
United Kingdom
Contacts
Name:  
Address: 
Telephone:
Email:
Affiliation: 
Name: Peter  Odor
Address:  East Surrey Hospital Canada Avenue RH1 5RH Redhill United Kingdom
Telephone: +44 7746 399221
Email: peter.odor@nhs.net
Affiliation: 
Key inclusion & exclusion criteria
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


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
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)
Intervention(s)
All patients recruited into the study are admitted to hospital with a fractured neck of femur and will receive an analgesic nerve block, called a fascia iliaca compartment block (FICB) prior to surgery. The intervention in the study is to place an intravenous catheter for sampling blood following injection of local anaesthetic during the nerve block. Blood sampling involves removal of less than 5ml of blood on each occasion and occurs at the following time intervals following FICB: 10, 20, 30, 45, 60, 75, 90, 105, 120, 240 minutes. Pain scores at rest and on 15 degree passive straight leg raise will be recorded using the Numerical Rating Scale (NRS-11) system.

Blood samples will be tested using a validated GC-MS and ELISA assays to produce data on plasma levobupivacaine and alpha-1 glycoprotein concentration.

Investigators will review patient records to obtain relevant data on patient age, weight, height, gender, renal function, albumin and concurrent medication, intravenous fluid administration and supplemental analgesia provided.
Primary Outcome(s)
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(s)
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
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
3. Patient demographics, renal function, intravenous fluid administration, supplemental analgesia requirements are measured using medical record review at baseline
Secondary ID(s)
32449
Source(s) of Monetary Support
Regional Anaesthesia - UK (RA-UK)
Secondary Sponsor(s)
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