Acute Hip Fracture and Spinal Anaesthesia Injection Time
Hemodynamic Effects During Fast vs Slow Injection Time of Spinal Anaesthesia in Elderly Patients With Acute Hip Fracture .
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Both general and spinal anesthesia is known for inducing hypotension, which may be a problem for the elderly patients, often with many co-morbidities, causing a risk of organ hypoperfusion. At our clinic the investigators have a great experience with the neuraxial technique when operating these patients. Based on clinical experience the investigators hypothesise that a slow injection rate of the spinal dos would reduce the incidence and degree of hypotension. The investigators also aim to study the changes in the hemodynamic response between the groups in more detail as mentioned below.
Patients planned for acute hip fracture surgery in spinal anaesthesia at our hospital and fulfills the inclusion criteria will be included in our study. The investigators plan to include 90 patients, randomized in two groups where Group A will be given a spinal anaesthesia in 15s and Group B in 90s.
After arriving to the preoperative area, the patients will be given 5 L oxygen on a face mask and a standard monitoring with ECG, pulse- oximetry will be started, followed by the placement of a venous cannula and a radial arterial line. The patients will also be given a fascia iliaca compartment block (FIC) with ropivacaine 3,75 mg/ml 35-40 ml for comfort. In addition, the FloTrac system will be set up, using the existing arterial line, for advanced hemodynamic monitoring including invasive mean arterial pressure (MAP), Cardiac Index (CI), Heart Rate (HR), Stroke Volume (SV) and System Vascular Resistance (SVR)/ (SVRI).
A lumbal spinal anesthesia will be performed using a 25G pencil point needle. The intrathecal dose of anesthesia consists of isobar bupivacaine 5mg/ml 2,4 ml and fentanyl 50ug/ml 0,4ml. Sensory level will be monitored by "cold spray" Hypotension will be defined as a fall in MAP by >30% or MAP < 65 mmHg. As an surrogate factor for the aggregated time of hypotension the total amount of given vasopressor will be calculated.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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V. Götaland
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Mölndal, V. Götaland, Sweden, 43130
- Gothenburg University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- >65 years of age
- patient with hip fracture
- ASA >/=2
- scheduled for acute surgery in spinal anesthesia, 5. mentally intact to give informed consent
Exclusion Criteria:
- anticoagulantion medication
- planned for general anesthesia
- surgery delayed > 72h
- lack of informed consent.
- severe aortic stenosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 15 s injection time
Patients in group A will be given the spinal anesthesia with an injection time of 15 s
|
As proxy for hypotension we record amount of Norepinephrine given during the study time of 30 minutes
|
|
Active Comparator: 90 s injection time
Patients in group B will be given the spinal anesthesia with an injection time of 90 s
|
As proxy for hypotension we record amount of Norepinephrine given during the study time of 30 minutes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean arterial pressure (MAP)
Time Frame: 10 minutes before and 45 minutes after the intrathecal dose is given
|
change in MAP after spinal anesthesia
|
10 minutes before and 45 minutes after the intrathecal dose is given
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac Output (CO)
Time Frame: 10 minutes before and 45 minutes after the intrathecal dose is given
|
CO change over time and relation to the speed of injection of the spinal anesthesia
|
10 minutes before and 45 minutes after the intrathecal dose is given
|
|
Systemic vascular resistance over time and relation to the speed of injection of the spinal anesthesia
Time Frame: 10 minutes before and 45 minutes after the intrathecal dose is given
|
10 minutes before and 45 minutes after the intrathecal dose is given
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bengt MD Nellgård, Prof, Sahlgrenska University Hospital /Mölndal, Sweden
Publications and helpful links
General Publications
- Griffiths R, Babu S, Dixon P, Freeman N, Hurford D, Kelleher E, Moppett I, Ray D, Sahota O, Shields M, White S. Guideline for the management of hip fractures 2020: Guideline by the Association of Anaesthetists. Anaesthesia. 2021 Feb;76(2):225-237. doi: 10.1111/anae.15291. Epub 2020 Dec 2.
- Nakasuji M, Suh SH, Nomura M, Nakamura M, Imanaka N, Tanaka M, Nakasuji K. Hypotension from spinal anesthesia in patients aged greater than 80 years is due to a decrease in systemic vascular resistance. J Clin Anesth. 2012 May;24(3):201-6. doi: 10.1016/j.jclinane.2011.07.014.
- Wiles MD, Moran CG, Sahota O, Moppett IK. Nottingham Hip Fracture Score as a predictor of one year mortality in patients undergoing surgical repair of fractured neck of femur. Br J Anaesth. 2011 Apr;106(4):501-4. doi: 10.1093/bja/aeq405. Epub 2011 Jan 28.
- Pitkanen M, Rosenberg P, Silvanto M, Tuominen M. Haemodynamic changes during spinal anaesthesia with slow continuous infusion or single dose of plain bupivacaine. Acta Anaesthesiol Scand. 1992 Aug;36(6):526-9. doi: 10.1111/j.1399-6576.1992.tb03512.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Wounds and Injuries
- Leg Injuries
- Fractures, Bone
- Femoral Fractures
- Hip Injuries
- Hypotension
- Hip Fractures
- Organic Chemicals
- Hydrocarbons
- Hydrocarbons, Cyclic
- Hydrocarbons, Aromatic
- Amines
- Catechols
- Phenols
- Benzene Derivatives
- Alcohols
- Amino Alcohols
- Ethanolamines
- Biogenic Monoamines
- Biogenic Amines
- Catecholamines
- Norepinephrine
Other Study ID Numbers
- Spinal time
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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