Acute Hip Fracture and Spinal Anaesthesia Injection Time

Anesthesia Clinical Trial

Official title:

Hemodynamic Effects During Fast vs Slow Injection Time of Spinal Anaesthesia in Elderly Patients With Acute Hip Fracture .

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05564741
• Other study ID #: Spinal time
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Bengt MD Nellgård, Prof
• Phone: +46076968680
• Email: bengt.nellgard[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The systemic effects of spinal anesthesia is not fully known. Our aim of this study is to assess whether there is a difference in hemodynamic effects if the spinal dose is given fast (15s) or slow (90s) in elderly patients with acute hip fracture (AHF). Ninety (n=90) patients with AHF planned for surgery within 72h at our hospital will be enrolled in the study and randomly devided into two groups. The patients will receive one predetermined dose of spinal anesthesia followed by an advanced minimally-invasive hemodynamic monitoring through an arterial line using FloTrac-system. The hemodynamic parameters will be conducted 10 minutes prior to the spinal anaesthesia and 30 minutes after the spinal block is given. Hypotension was defined as a fall in MAP > 30 % or a MAP <65mmHg.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. >65 years of age

2. patient with hip fracture

3. ASA >/=2

4. scheduled for acute surgery in spinal anesthesia, 5. mentally intact to give informed consent

Exclusion Criteria:

1. anticoagulantion medication

2. planned for general anesthesia

3. surgery delayed > 72h

4. lack of informed consent.

5. severe aortic stenosis

Related Conditions & MeSH terms

• Anesthesia
• Fractures, Bone
• Hip Fractures
• Hypotension

Intervention

Drug:
• Norepinephrine 1 MG/ML
As proxy for hypotension we record amount of Norepinephrine given during the study time of 30 minutes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

References & Publications (4)

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. Review. — View Citation

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. — View Citation

Pitkänen 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean arterial pressure (MAP)	change in MAP after spinal anesthesia	10 minutes before and 45 minutes after the intrathecal dose is given
Secondary	Cardiac Output (CO)	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
Secondary	Systemic vascular resistance 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