Fractionated Spinal Anesthesia With Combined Isobaric and Hyperbaric Bupivacaine for Elderly Hip Fracture Patients

May 5, 2026 updated by: Mai Salah Salem, Tanta University

Fractionated Spinal Anesthesia With Combined Isobaric and Hyperbaric Bupivacaine Toward Safer Anesthesia for Elderly Hip Fracture Patients: Randomized Controlled Study

This prospective randomized controlled study will be conducted to compare the effect of fractionated SA using isobaric and hyperbaric bupivacaine with fractionated SA using hyperbaric bupivacaine and the conventional SA on hemodynamic instability in orthogeriatric patients undergoing hip fracture surgeries.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Hip fractures are one of the most common reasons for elderly patients to present to the emergency department and require urgent surgery. Despite the debate regarding the preferred type of anesthesia in the elderly population, spinal anesthesia has shown the advantage of the simplicity of the technique, the better analgesic profile, the lower incidence of thromboembolic events and lower hospital stay. Hemodynamic stability should be considered as a primary intraoperative target. In pursuit of optimizing spinal anesthesia, this study proposed that fractionated SA by sequential administration of low doses of isobaric and hyperbaric bupivacaine can minimize hemodynamic instability while leveraging the advantages of both solutions when compared with fractionated SA using hyperbaric bupivacaine or the conventional SA technique.

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Tanta university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Elderly patients of both gender aged 65 years or more with American Society of Anesthesiologists (ASA) Physical Status I-III, who were scheduled for hip fracture surgeries under Spinal anesthesia

Exclusion criteria:

  • Patients declined to participate in the trial.
  • Patients on anticoagulation therapy.
  • Patients planned for general anesthesia.
  • Patients with atrial fibrillation.
  • Allergies or hypersensitivity to local anesthetic drugs.
  • Spinal cord deformities.
  • Infection that contraindicate SA.
  • Preoperative motor and sensory deficits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fractionated SA with isobaric and hyperbaric bupivacaine
patients will receive fractionated SA in two doses first dose of hyperbaric bupivacaine with fentanyl followed after 90 seconds by the second dose of isobaric bupivacaine.
Procedure: Fractionated SA with isobaric and hyperbaric bupivacaine
patients will receive fractionated SA in two doses first dose of hyperbaric bupivacaine with fentanyl followed after 90 seconds by the second dose of isobaric bupivacaine.
Other Names:
  • Arm 1
Active Comparator: Fractionated SA with hyperbaric bupivacaine group
patients will receive fractionated SA in two doses of hyperbaric bupivacaine and fentanyl, two thirds of the dose will be given firstly followed by the last third after 90 seconds.
Procedure: Fractionated SA with hyperbaric bupivacaine
patients will receive fractionated SA in two doses of hyperbaric bupivacaine and fentanyl, two thirds of the dose will be given firstly followed by the last third after 90 seconds.
Other Names:
  • Arm 2
Active Comparator: Conventional SA group
patients will receive the conventional SA bolus dose of hyperbaric bupivacaine and fentanyl.
Procedure: Conventional SA group
patients will receive the conventional SA bolus dose of hyperbaric bupivacaine and fentanyl.
Other Names:
  • Arm 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of intraoperative hypotension
Time Frame: MAP will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery.
Intraoperative hypotension is defined as the drop of systolic blood pressure (SBP) by 25% of the basal reading or the drop of MAP below 65 mmHg.
MAP will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of bradycardia.
Time Frame: HR will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery.
Bradycardia is defined as sustained HR less than 60 beat/ minute
HR will be measured intraoperatively before spinal anesthesia (SA), immediately after administering SA and subsequently at regular intervals 5, 10, 20, 30, 60, 75, 90 minutes, and then every 30 minutes till the end of surgery.
Vasopressor requirements.
Time Frame: intraoperatively after spinal anesthesia till the end of surgical intervention
total dose of vasopressors required intraoperatively
intraoperatively after spinal anesthesia till the end of surgical intervention
Postoperative pain score
Time Frame: immediately post operatively then every 30 minutes up to 2 hour

Visual analogue scale (VAS) is typically a 10-cm horizontal line labeled:

  • 0 = No pain
  • 10 = Worst imaginable pain

A patient marks a point along the line to indicate their level of pain. The score is then measured in centimeters or millimeters to quantify pain intensity.
immediately post operatively then every 30 minutes up to 2 hour
Time to first rescue analgesia
Time Frame: post operative .. time interval from the end of surgery until need of rescue analgesia
time interval from the end of surgery until need of rescue analgesia
post operative .. time interval from the end of surgery until need of rescue analgesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 20, 2026

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR131034/10/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author

IPD Sharing Time Frame

The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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