Continuous Versus Single-Shot Spinal Anesthesia for Orthopedic Surgery

NCT ID: NCT06625606

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2024-12-01

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Single-shot spinal anesthesia (SSSA)

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine 0.5% Injectable Solution

Intervention Type: 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.

Continuous spinal anesthesia (CSA)

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.

Group Type: ACTIVE_COMPARATOR

Bupivacaine 0.5% Injectable Solution

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Isoflurane Inhalant Product

Intervention Type: 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.

Interventions

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. 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.

Intervention Type: DRUG

Bupivacaine 0.5% Injectable Solution

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Eman M Elafifi

Lecturer of Anesthesia, Pain & ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha University

Banhā, El Qalyoubia, Egypt

Countries

Egypt

Other Identifiers

RC 5/9/2024

Identifier Type: -

Identifier Source: org_study_id