Continuous Versus Single-Shot Spinal Anesthesia for Orthopedic Surgery

NCT06625606 | Completed

• 1 other identifier: RC 5/9/2024
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (3)

Single-shot spinal anesthesia (SSSA)

ACTIVE COMPARATOR

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

Continuous spinal anesthesia (CSA)

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

Bupivacaine 0.5% Injectable Solution 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.

Single-shot spinal anesthesia (SSSA)

Isoflurane Inhalant Product 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.

General anesthesia

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, El Qalyoubia, 13511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Pain & ICU

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 3, 2024
• Study Start: September 10, 2024
• Primary Completion: November 15, 2024
• Study Completion: December 1, 2024
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

EG (1)