Acute Hip Fracture and Spinal Anaesthesia Injection Time

NCT05564741 | Completed Phase 4 FDA Drug

• 1 other identifier: Spinal time
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypotension; Hip Fractures; Anesthesia

Keywords

hip fracture; spinal anesthesia; hypotension; injection time

Outcome Measures

Primary Outcomes (1)

• Mean arterial pressure (MAP)

  change in MAP after spinal anesthesia

  10 minutes before and 45 minutes after the intrathecal dose is given

Secondary Outcomes (2)

• Cardiac Output (CO)

  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

  10 minutes before and 45 minutes after the intrathecal dose is given

Study Arms (2)

15 s injection time

ACTIVE COMPARATOR

Patients in group A will be given the spinal anesthesia with an injection time of 15 s

Drug: Norepinephrine 1 MG/ML

90 s injection time

ACTIVE COMPARATOR

Patients in group B will be given the spinal anesthesia with an injection time of 90 s

Drug: Norepinephrine 1 MG/ML

Interventions

Norepinephrine 1 MG/ML DRUG

As proxy for hypotension we record amount of Norepinephrine given during the study time of 30 minutes

15 s injection time; 90 s injection time

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \>65 years of age
• patient with hip fracture
• ASA \>/=2
• scheduled for acute surgery in spinal anesthesia, 5. mentally intact to give informed consent

You may not qualify if:

• anticoagulantion medication
• planned for general anesthesia
• surgery delayed \> 72h
• lack of informed consent.
• severe aortic stenosis

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Gothenburg University

Mölndal, V. Götaland, 43130, Sweden

Location

Related 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.

  PMID: 33289066 BACKGROUND

• 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.

  PMID: 22537572 BACKGROUND

• 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.

  PMID: 21278153 BACKGROUND

• 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.

  PMID: 1514336 BACKGROUND

MeSH Terms

Conditions

Hypotension; Hip Fractures

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Bengt MD Nellgård, Prof

  Sahlgrenska University Hospital /Mölndal, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of department

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: October 20, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)