Completed

Local Anesthetic Volumes for Spinal Anesthesia in Varicose Vein Surgery

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

4 mg bupivacaine

+ 6 mg bupivacaine

Procedure
Who is being recruted

From 18 to 80 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2024
See protocol details

Summary

Principal SponsorAnkara Etlik City Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 30, 2024

Actual date on which the first participant was enrolled.

Varicose veins are enlarged veins that appear as twisted, swollen veins under the skin, typically in the legs and feet. This study focuses on improving anesthesia methods used during surgeries for these veins. It aims to explore how different amounts of spinal anesthetic can affect the surgery experience, especially looking at the level of numbness achieved and how quickly patients can go home after surgery. Since varicose vein surgeries can involve different types of anesthesia, finding the optimal dose for spinal anesthesia may lead to better patient outcomes and quicker recovery times. In this study, participants undergoing surgery for varicose veins will receive spinal anesthesia through an injection into the lower back. Researchers will use different doses of the anesthetic to see how it affects sensation and recovery. The study will monitor the effects during the surgery and the recovery period, assessing the level of numbness and how soon patients can leave the hospital. By comparing these outcomes, the study hopes to identify the best anesthetic dose that ensures patient comfort and efficient recovery.

Official TitleDifferent Local Anesthetic Volumes for Unilateral Spinal Anesthesia in Varicose Vein Surgery
NCT06527430
Principal SponsorAnkara Etlik City Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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

5 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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.

Group II

Active Comparator
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Ankara Etlik City Hospital

Yenimahalle, Turkey (Türkiye)Open Ankara Etlik City Hospital in Google Maps
CompletedOne Study Center