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Completed

NCT Number: NCT06625606

Continuous Versus Single-Shot Spinal Anesthesia for Orthopedic Surgery

A study was conducted to compare the effectiveness of continuous spinal anesthesia (CSA), single-shot spinal anesthesia (SSSA), and general anesthesia (GA) in patients over 60 years of age undergoing elective surgical repair of a fractured neck of femur. One hundred and five patients were randomly assigned to one of the three groups. The SSSA group received a single intrathecal injection of isobaric bupivacaine 0.5%, while the CSA group received multiple injections of the same anesthetic through a catheter placed in the subarachnoid space. The GA group received isoflurane anesthesia. Intraoperatively, blood pressure was monitored to assess the frequency of hypotension and the required dose of ephedrine. Additionally, the total dose of bupivacaine administered and the frequency of intraoperative fentanyl were recorded. Postoperatively, the duration of postoperative analgesia, pain scores, and need for additional pain medication were evaluated.

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Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banhā, El Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of American Society of Anesthesiologists (ASA) grade ≤III;
  • Patients were assigned for elective surgical intervention for Fixation of Neck Femur;
  • Patients were free of exclusion criteria.

Exclusion criteria

  • Patients of American Society of Anesthesiologists (ASA) grade >III;
  • Patients who had uncontrolled hypertension and/or diabetes mellitus;
  • Patients who had uncompensated cardiac, renal, or hepatic diseases;
  • Patients with coagulopathy, spinal deformity, allergy, or contraindication for the used drugs;
  • Patients who refused to sign the informed consent were excluded from the study.

Treatment and study plan

Bupivacaine 0.5% Injectable Solution

Drug

The patient's back was prepared for surgery. They were positioned on their side, with the operative side facing upward. The L3-4 spinal interspace was identified, and numbed, and a thin spinal needle was inserted. After confirming Cerebrospinal Fluid (CSF), 12.5 mg of isobaric bupivacaine 0.5% was injected into the spinal canal.

Isoflurane Inhalant Product

Drug

General anesthesia was initiated with propofol and rocuronium. Anesthesia was maintained with isoflurane, with additional rocuronium and fentanyl as needed. Breathing was controlled by the ventilator, and muscle relaxation was reversed at the end of surgery.

Primary outcomes

  1. Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post orthopedic surgery.

    Time frame: 3 months

    Value of Continuous Spinal Anesthesia in Pain Reduction Post-operative manifested by Total dose of Post Operative analgesia.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Continuous Spinal Anesthesia for Patients Planned For Major Orthopedic Surgeries: Versus Single-Shot Spinal Anesthesia: A Case-Control Comparative Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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