Continuous Versus Single-Shot Spinal Anesthesia for Orthopedic Surgery

Not Applicable

Recruiting

• Conditions: Post Operative Pain
• Interventions: Drug: Bupivacaine 0.5% Injectable Solution; Drug: Isoflurane Inhalant Product

• Registration Number: NCT06625606
• Lead Sponsor: Benha University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Study First Submitted: 2024-09-29
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-28
• Primary Completion: 2024-11-15
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-shot spinal anesthesia (SSSA)	Bupivacaine 0.5% Injectable Solution	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.
Continuous spinal anesthesia (CSA)	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.
General anesthesia	Isoflurane Inhalant Product	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 Outcome Measures

Name	Time	Method
Proportion of patients reporting at least a 50% reduction in pain (measured by Numerical Rating Scale) post orthopedic surgery.	3 months	Value of Continuous Spinal Anesthesia in Pain Reduction Post-operative manifested by Total dose of Post Operative analgesia.

Trial Locations

Locations (1)

Benha University; 🇪🇬 Banhā, El Qalyoubia, Egypt