Conventional Spinal Anaesthesia Versus Fractional Spinal Anaesthesia on Hemodynamics

Comparative Study Between Conventional Spinal Anaesthesia and Fractional Spinal Anaesthesia on Systemic Haemodynamics in Frail Elderly Hip Fracture Patients

compare the systemic haemodynamic response to fractional spinal anaesthesia versus conventional spinal anaesthesia , in a group of elderly and comorbid patients with hip fracture.

Study Overview

• Status: Recruiting
• Conditions: Hip Fractures
• Intervention / Treatment: Procedure: Fractional Spinal Anaesthesia.; Procedure: Conventional Spinal Anaesthesia

Detailed Description

Spinal anaesthesia affects sympathetic chain activity, leading to a reduction in vasomotor tone.It was found that the incidence of hypotension following single-shot spinal anaesthesia, has previously been described as being 28-69%. As a matter of fact, autonomic nervous system function plays a key role in the development of haemodynamic instability and intraoperative hypotension . Haemodynamic stability should be considered as a primary intraoperative target, since several findings suggest avoiding systemic pressure drops . It was found that hypotension is primarily related to the overall dose injected ; however, several other variables, including the volume, the type of the anaesthetics injected, different adjuvant agents, and pre- and intraoperative factors, may impact the haemodynamic effect of the SA.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ahmed yousri, master; Phone Number: 01141556766; Email: ahmed.yousri@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with hip fractures.
• Patients age >60 years old.
• ASA ≤ 3.

Exclusion Criteria:

• Patients on anticoagulant medication.
• Planned for general anaesthesia .
• Patients had atrial fibrillation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fractional Spinal Anaesthesia. Group A.; An intrathecal catheter 20 G will be then inserted 4-5 cm into the intrathecal space.This technique of SA will be performed on all patients , the needle should be inserted between L3 and L4 space or L4 and L5 space in order to avoid injury to the spinal cord. An intrathecal mixture (5mL) containing 3 mg/ml hyperbaric bupivacaine and 1 μg/ml dexmedetomidine will be prepared. Intrathecal anaesthesia will be induced by giving 2 mL (6 mg of hyperbaric bupivacaine and 2 μg of dexmedetomidine ) of the mixture, followed by a second 2 mL injection after 25 min.	Procedure: Fractional Spinal Anaesthesia.; An intrathecal catheter 20 G will be then inserted 4-5 cm into the intrathecal space.This technique of SA will be performed on all patients , the needle should be inserted between L3 and L4 space or L4 and L5 space in order to avoid injury to the spinal cord. An intrathecal mixture (5mL) containing 3 mg/ml hyperbaric bupivacaine and 1 μg/ml dexmedetomidine will be prepared. Intrathecal anaesthesia will be induced by giving 2 mL (6 mg of hyperbaric bupivacaine and 2 μg of dexmedetomidine ) of the mixture, followed by a second 2 mL injection after 25 min. (i.e., a total intrathecal dose (4mL) of 12 mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ).; Procedure: Conventional Spinal Anaesthesia; Intrathecal anaesthesia will be induced by giving 12.5 mg Hyperbaric bupivacaine (2.5mL) and 4 μg of dexmedetomidine (1mL) (i.e., a total intrathecal dose (3.5 mL) of 12.5mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ). (Mohamed T et al., 2017). Sensory level will be monitored by "cold spray". Haemodynamic recordings will be documented every five minutes up until 45 minutes.
Active Comparator: Conventional Spinal Anaesthesia. Group B.; Intrathecal anaesthesia will be induced by giving 12.5 mg Hyperbaric bupivacaine (2.5mL) and 4 μg of dexmedetomidine (1mL) (i.e., a total intrathecal dose (3.5 mL) of 12.5mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ). Sensory level will be monitored by "cold spray". Haemodynamic recordings will be documented every five minutes up until 45 minutes.	Procedure: Fractional Spinal Anaesthesia.; An intrathecal catheter 20 G will be then inserted 4-5 cm into the intrathecal space.This technique of SA will be performed on all patients , the needle should be inserted between L3 and L4 space or L4 and L5 space in order to avoid injury to the spinal cord. An intrathecal mixture (5mL) containing 3 mg/ml hyperbaric bupivacaine and 1 μg/ml dexmedetomidine will be prepared. Intrathecal anaesthesia will be induced by giving 2 mL (6 mg of hyperbaric bupivacaine and 2 μg of dexmedetomidine ) of the mixture, followed by a second 2 mL injection after 25 min. (i.e., a total intrathecal dose (4mL) of 12 mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ).; Procedure: Conventional Spinal Anaesthesia; Intrathecal anaesthesia will be induced by giving 12.5 mg Hyperbaric bupivacaine (2.5mL) and 4 μg of dexmedetomidine (1mL) (i.e., a total intrathecal dose (3.5 mL) of 12.5mg of hyperbaric bupivacaine and 4 μg of dexmedetomidine ). (Mohamed T et al., 2017). Sensory level will be monitored by "cold spray". Haemodynamic recordings will be documented every five minutes up until 45 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Is to measure blood pressure change intra-operative operative operative (2 hours)	blood pressure monitoring	2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain score for 24 hours	pain score using the Visual Analogue Scale	within 24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: ahmed saudi, professor, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: June 23, 2024
• First Submitted That Met QC Criteria: September 1, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: fractional spinal
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures; Hip Injuries; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: FMASU MD76/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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