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

NCT ID: NCT07288996

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-20

Study Completion Date

2026-06-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Anesthesia in Elderly Patients

Keywords

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Fractionated spinal anesthesia hyperbaric bupivacaine isobaric bupivacaine hip fructure elderly patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Fractionated SA with isobaric and hyperbaric bupivacaine

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

Fractionated SA with hyperbaric bupivacaine

Intervention Type PROCEDURE

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.

Conventional SA group

patients will receive the conventional SA bolus dose of hyperbaric bupivacaine and fentanyl.

Group Type ACTIVE_COMPARATOR

Conventional SA group

Intervention Type PROCEDURE

patients will receive the conventional SA bolus dose of hyperbaric bupivacaine and fentanyl.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Conventional SA group

patients will receive the conventional SA bolus dose of hyperbaric bupivacaine and fentanyl.

Intervention Type PROCEDURE

Other Intervention Names

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Arm 1 Arm 2 Arm 3

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Mai Salah Salem

Lecturer of anesthesia, Surgical intensive care and pain medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mai Salah Salem, MD anesthesia, SIC and pain ma

Role: CONTACT

Phone: +00201061107658

Email: [email protected]

References

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James LA, Levin MA, Lin HM, Deiner SG. Association of Preoperative Frailty With Intraoperative Hemodynamic Instability and Postoperative Mortality. Anesth Analg. 2019 Jun;128(6):1279-1285. doi: 10.1213/ANE.0000000000004085.

Reference Type RESULT
PMID: 31094800 (View on PubMed)

Meyhoff CS, Hesselbjerg L, Koscielniak-Nielsen Z, Rasmussen LS. Biphasic cardiac output changes during onset of spinal anaesthesia in elderly patients. Eur J Anaesthesiol. 2007 Sep;24(9):770-5. doi: 10.1017/S0265021507000427. Epub 2007 Apr 27.

Reference Type RESULT
PMID: 17462120 (View on PubMed)

Messina A, Frassanito L, Colombo D, Vergari A, Draisci G, Della Corte F, Antonelli M. Hemodynamic changes associated with spinal and general anesthesia for hip fracture surgery in severe ASA III elderly population: a pilot trial. Minerva Anestesiol. 2013 Sep;79(9):1021-9. Epub 2013 May 2.

Reference Type RESULT
PMID: 23635998 (View on PubMed)

Alrefaey AK, Bakrey SA. Sequential Intrathecal Injection of Hyperbaric and Isobaric Bupivacaine in Orthogeriatric Lower Limb Surgery, a Prospective Randomized Study. Asian J Anesthesiol. 2022 Jun 1;60(2). doi: 10.6859/aja.202206_60(2).0004. Epub 2022 May 4.

Reference Type RESULT
PMID: 35607733 (View on PubMed)

Niu Z, Xu X, Chu H, Yin J. Anesthetic management of hip fracture in geriatric patient with respiratory and heart failure using pericapsular nerve group block: A case report. Medicine (Baltimore). 2022 Jun 3;101(22):e29478. doi: 10.1097/MD.0000000000029478.

Reference Type RESULT
PMID: 35665737 (View on PubMed)

Carpintero P, Caeiro JR, Carpintero R, Morales A, Silva S, Mesa M. Complications of hip fractures: A review. World J Orthop. 2014 Sep 18;5(4):402-11. doi: 10.5312/wjo.v5.i4.402. eCollection 2014 Sep 18.

Reference Type RESULT
PMID: 25232517 (View on PubMed)

Other Identifiers

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36264PR131034/10/25

Identifier Type: -

Identifier Source: org_study_id