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

NCT07288996 | Active Not Recruiting DMC

• 1 other identifier: 36264PR131034/10/25
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Anesthesia in Elderly Patients

Keywords

Fractionated spinal anesthesia; hyperbaric bupivacaine; isobaric bupivacaine; hip fructure; elderly patients

Outcome Measures

Primary Outcomes (1)

• Incidence of intraoperative hypotension

  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 Outcomes (4)

• Incidence of bradycardia.

  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.

  intraoperatively after spinal anesthesia till the end of surgical intervention

• Postoperative pain score

  immediately post operatively then every 30 minutes up to 2 hour

• Time to first rescue analgesia

  post operative .. time interval from the end of surgery until need of rescue analgesia

Study Arms (3)

Fractionated SA with isobaric and hyperbaric bupivacaine

EXPERIMENTAL

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

Fractionated SA with hyperbaric bupivacaine group

ACTIVE COMPARATOR

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

Conventional SA group

ACTIVE COMPARATOR

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

Procedure: Conventional SA group

Interventions

Fractionated SA with isobaric and hyperbaric bupivacaine 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.

Also known as: Arm 1

Fractionated SA with isobaric and hyperbaric bupivacaine

Fractionated SA with hyperbaric bupivacaine 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.

Also known as: Arm 2

Fractionated SA with hyperbaric bupivacaine group

Conventional SA group PROCEDURE

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

Also known as: Arm 3

Conventional SA group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university hospital

Tanta, Egypt

Location

Related Publications (6)

• 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.

  PMID: 31094800 RESULT

• 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.

  PMID: 17462120 RESULT

• 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.

  PMID: 23635998 RESULT

• 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.

  PMID: 35607733 RESULT

• 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.

  PMID: 35665737 RESULT

• 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.

  PMID: 25232517 RESULT

MeSH Terms

Interventions

DMAC2L protein, human

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, Surgical intensive care and pain medicine

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 17, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)