Continuous Versus Single-Shot Spinal Anesthesia for Orthopedic Surgery

Benha University

Status: Completed

Conditions: Post Operative Pain

Treatments: Drug: Isoflurane Inhalant Product; Drug: Bupivacaine 0.5% Injectable Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06625606

RC 5/9/2024

Details and patient eligibility

About

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.

Enrollment: 105 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups

Single-shot spinal anesthesia (SSSA)

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine 0.5% Injectable Solution

Drug: Bupivacaine 0.5% Injectable Solution

Continuous spinal anesthesia (CSA)

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine 0.5% Injectable Solution

Drug: Bupivacaine 0.5% Injectable Solution

General anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: Isoflurane Inhalant Product