An interventional study of Bupivacaine 0.5% Injectable Solution and Bupivacaine 0.5% Injectable Solution in Post Operative Pain, sponsored by Benha University. Completed at 1 site in Egypt. Open to participants aged 60 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-31.
Sponsored by Benha University · Not applicable, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 105 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
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The patient's back was prepared for surgery. They were positioned on their side, with the operative side facing upward. A thin spinal needle was inserted into the L3-4 spinal interspace, after numbing the area. Once cerebrospinal fluid was confirmed, a small dose of isobaric bupivacaine was injected into the spinal canal.
Drug: Bupivacaine 0.5% Injectable Solution
A thicker needle was inserted into the L3-4 spinal interspace. After confirming cerebrospinal fluid, a thin catheter was inserted into the spinal canal and secured. An initial dose of isobaric bupivacaine was injected, followed by additional doses as needed to maintain the block height.
Drug: Bupivacaine 0.5% Injectable Solution
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.
Drug: Isoflurane Inhalant Product
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.
The 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.
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.
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post orthopedic surgery.
Value of Continuous Spinal Anesthesia in Pain Reduction Post-operative manifested by Total dose of Post Operative analgesia.
Time frame: 3 months
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Benha University