Clinical Trials Directory

Trials / Completed

CompletedNCT06625606

Continuous Versus Single-Shot Spinal Anesthesia for Orthopedic Surgery

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
105 (actual)
Sponsor
Benha University · Academic / Other
Sex
All
Age
60 Years – 75 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGBupivacaine 0.5% Injectable SolutionThe 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.
DRUGBupivacaine 0.5% Injectable SolutionThe L3-4 spinal interspace was identified, numbed, and a thicker needle (Tuohy needle) was inserted. After confirming Cerebrospinal Fluid (CSF), a thin catheter was inserted into the spinal canal and secured. An initial dose of 1 ml isobaric bupivacaine 0.5% was injected, followed by additional doses as needed to maintain the block height.
DRUGIsoflurane Inhalant ProductGeneral 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.

Timeline

Start date
2024-09-10
Primary completion
2024-11-15
Completion
2024-12-01
First posted
2024-10-03
Last updated
2026-03-31

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT06625606. Inclusion in this directory is not an endorsement.