Fractional Spinal Anesthesia and Systemic Hemodynamics in Frail Elderly Hip Fracture Patients.

Aging and frailty make the elderly patients susceptible to hypotension following spinal anaesthesia. The systemic haemodynamic effects of spinal anaesthesia are not well known. In this study, we examine the systemic haemodynamic effects of fractional spinal anaesthesia following intermittent microdosing of a local anesthetic and an opioid.

We included 15 patients aged over 65 with considerable comorbidities, planned for emergency hip fracture repair. Patients received a spinal catheter and cardiac output monitoring using the LiDCOplus system. Invasive mean arterial pressure (MAP), cardiac index, systemic vascular resistance index, heart rate and stroke volume index were registered. Two doses of bupivacaine 2,25 mg and fentanyl 15µg were administered with 25 minutes in between. Hypotension was defined as a fall in MAP by >30% or a MAP <65 mmHg

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Anesthesia; Cardiac Output, Low; Hypotension Drug-Induced
• Intervention / Treatment: Drug: Bupivacain

Detailed Description

We daily screened patients planned for hip fracture surgery and these were identified through the theatre planning software (Orbit, TietoEVRY, Espoo, Finland). Nottingham Hip Fracture Score was calculated. This scoring system includes objective factors like age, sex, dementia, previous cancer, living facility and comorbidity. NHFS varies from 1-10 with higher numbers correlated to higher 30-day mortality. ASA grade was also recorded after study inclusion.

After arriving to the preoperative area, patients were given 5 liters of oxygen on a face mask and ECG and pulse-oximetry monitoring were started. Oral premedication with standardized doses of paracetamol and oxycodone was given orally, followed by the placement of a venous 18G cannula in an antecubital vein and a radial arterial catheter (20G). The patient was also given a fascia iliaca compartment (FIC) block, or an ultrasound guided femoral nerve block with ropivacaine 3.5mg/ml 20-40ml, to decrease discomfort when given the neuraxial block. In addition, the LiDCOplus (LiDCO Group Plc, London, England) system was set up according to manufacturer's instructions. The system was calibrated with 0.3-0.45 mmol lithium chloride depending on body weight. After calibration and baseline parameter registration, the LiDCOplus system provided cardiac output variables and based on these and the invasive blood pressure, haemodynamic variables could be derived.

Following aseptic skin preparation of the lumbar area, a subarachnoid puncture by a 18G Tuohy needle was performed either between the L2 - L3 or the L3 - L4 interspaces, preferably using a mid-line approach. An intrathecal catheter 20G was then inserted 4-5 cm into the intrathecal space. This technique of a continues spinal anaesthesia (CSA) was performed on all patients by one physician (FO). A solution (10 ml) containing 1.5 mg/ml bupivacaine and 10 µg/ml fentanyl was prepared. Intrathecal anaesthesia was induced by giving 1,5 ml (2.25 mg of bupivacaine and 15 µg of fentanyl) of the solution, followed by a second 1.5 ml injection after 25 min (i.e., a total intrathecal dos of 4.5 mg of bupivacaine and 30 µg of fentanyl). Sensory level was monitored by "cold spray". Hemodynamic recordings were performed every 5 minutes up until 45 minutes after initial intrathecal dose when research monitoring was terminated. The patient was then operated in the pre-planned time slot and was further managed at the discretion of the attending anesthetist.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Västra Götaland
    • Gothenburg, Västra Götaland, Sweden
      • Sahlgrenska University Hospital /Mölndal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. patient with hip fracture,
2. >65 years of age,
3. ASA ≥2, 4) scheduled for neuraxial anaesthesia and 5) mentally intact to give informed consent. This could also be given by next-of-kin, if the patient was cognitively impaired.

Exclusion Criteria:

1. lithium or anticoagulation medication,
2. planned for general anaesthesia,
3. ongoing atrial fibrillation,
4. if surgery was delayed >72 hours,
5. lack of informed consent and
6. patient agitation requiring intermittent sedation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fractional spinal anaesthesia; After FIC block or femoral nerve block with ropivacaine 3.5mg/ml 20-40ml. The LiDCOplus was calibrated with 0.3-0.45 mmol lithium based on body weight. After calibration and baseline parameter registration, the LiDCOplus system provided cardiac output variables A dural puncture by a 18G Tuohy needle was performed either between the L2 - L3 or the L3 - L4 interspaces, preferably using a mid-line approach. A catheter 20G was then inserted 4-5 cm into the intrathecal space. A solution (10 ml) of 1.5 mg/ml bupivacaine and 10 µg/ml fentanyl was prepared. Intrathecal anaesthesia was induced by giving 1,5 ml (2.25 mg of bupivacaine and 15 µg of fentanyl) of the solution, followed by a second 1.5 ml injection after 25 min. MAP was maintained with a norepinephrine to target a MAP >65mmHg or to avoid a > 30% decline in MAP from baseline. Invasive haemodynamic parameters were recorded every 5 min for 45 min after initial intrathecal dose was given.

Drug: Bupivacain; Interventional anaesthesia provided through an indwelling spinal catheter was administered according to protocol; Other Names: Fractional spinal anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial pressure	Mean arterial pressure change over time and in relation to intrathecal dosing	45 minutes
Cardiac Output	Cardiac Output change over time and in relation to intrathecal dosing	45 minutes
Systemic Vascular Resistance Index	Systemic vascular resistance indexchange over time and in relation to intrathecal dosing	45 minutes
Elastance	Arterial Elastance change over time and in relation to intrathecal dosing	45 minutes

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Investigators: Study Director: Bengt Nellgård, MD PhD, Head of det

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.
• Jakobsson J, Kalman SH, Lindeberg-Lindvet M, Bartha E. Is postspinal hypotension a sign of impaired cardiac performance in the elderly? An observational mechanistic study. Br J Anaesth. 2017 Dec 1;119(6):1178-1185. doi: 10.1093/bja/aex274.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): February 15, 2021
• Study Completion (Actual): February 16, 2021

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: hip fracture; hypotension; Spinal anaesthesia; fractional; cardiac output; elderly patients
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Hypotension; Cardiac Output, Low; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: Fractional Spinal LidCO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The number of participants is low and anonymity would be difficult to guarantee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No