Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia

Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia in Varicose Vein Surgery

Varicose veins are irreversible and abnormal enlargement of the veins. These veins appear and there are curled swellings under the skin in the feet and legs. Complaints increase when standing and sitting for long periods. For varicose veins in the initial stages, medical treatment methods such as compression socks (elastic socks) and elevating the feet as much as possible can be tried. For widespread varicose veins in more advanced stages, invasive procedures such as sclerotherapy and endovascular ablation are performed. These procedures can be performed under local, spinal or general anesthesia.

Spinal anesthesia; It is a type of neuraxial type of regional anesthesia characterized by injecting local anesthetic drugs into the subarachnoid space alone or together with other drugs, resulting in temporary sensory block, motor block, and sympathetic block. The local anesthetic volume administered during spinal anesthesia may affect the anesthesia levels and discharge times of the patients. For varicose vein surgeries, low-dose local anesthetic is sufficient for spinal anesthesia and can also provide early discharge.

This study will compare the peri-operative effects of different doses of spinal anesthesia in patients undergoing varicose vein surgery.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Ambulatory Surgery; Discharge Time
• Intervention / Treatment: Procedure: 4 mg bupivacaine; Procedure: 6 mg bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara
    • Yenimahalle, Ankara, Turkey, 06170
      • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18-80 years
• American Society of Anesthesiologists (ASA) score I-II
• Body Mass Index (BMI) between 18-30 kg/m2
• Patients who underwent spinal anesthesia (bupivacaine 4 mg or 6 mg) for varicose vein surgery in the operating theatre

Exclusion Criteria:

• Patients under 18 and over 80 years of age
• ASA score III and above
• Patients with a history of bleeding diathesis
• Patients with infection in the area to be treated
• BMI below 18 or above 30 kg/m2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Spinal anesthesia with 4 mg bupivacaine; After the patients are monitored, they will be placed in the lateral decubitus position. After appropriate field sterilization, patients will undergo unilateral spinal anesthesia with 4 mg bupivacaine. At the fifth minute after spinal anesthesia, patients will be placed in the supine position.	Procedure: 4 mg bupivacaine; Spinal anesthesia was applied to the patients with 4 mg bupivacaine in the lateral decubitus position.
Active Comparator: Spinal anesthesia with 6 mg bupivacaine; After the patients are monitored, they will be placed in the lateral decubitus position. After appropriate field sterilization, patients will undergo unilateral spinal anesthesia with 6 mg bupivacaine. At the fifth minute after spinal anesthesia, patients will be placed in the supine position.	Procedure: 6 mg bupivacaine; Spinal anesthesia was applied to the patients with 6 mg bupivacaine in the lateral decubitus position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discharge time	The time (minutes) from the application of spinal anesthesia to the patients' discharge will be recorded as the discharge period.	On the operation day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor block appearing time	Time (minutes) to complete motor block in the lower extremity after spinal anesthesia	On the operation day
Sensorial block appearing time	Time (minutes) to complete sensorial block in the lower extremity after spinal anesthesia	On the operation day
Motor block disappearing time	Time (minutes) to disappearance of complete motor block in the lower extremity after spinal anesthesia	On the operation day
Sensorial block disappearing time	Time (minutes) to disappearance of sensorial block in the lower extremity after spinal anesthesia	On the operation day

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2024
• Primary Completion (Actual): May 10, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: July 25, 2024
• First Submitted That Met QC Criteria: July 25, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: spinal anesthesia; ambulatory surgery; local anesthetic volume; varicose vein surgery
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Varicose Veins; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: AEŞH-EK1-2024-0074

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No