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Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06527430
Enrollment
80
Registered
2024-07-30
Start date
2024-07-30
Completion date
2025-05-30
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory Surgery, Discharge Time, Spinal Anesthesia

Keywords

local anesthetic volume, varicose vein surgery, ambulatory surgery, spinal anesthesia

Brief summary

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.

Interventions

PROCEDURE4 mg bupivacaine

Spinal anesthesia was applied to the patients with 4 mg bupivacaine in the lateral decubitus position.

PROCEDURE6 mg bupivacaine

Spinal anesthesia was applied to the patients with 6 mg bupivacaine in the lateral decubitus position.

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Discharge timeOn the operation dayThe time (minutes) from the application of spinal anesthesia to the patients' discharge will be recorded as the discharge period.

Secondary

MeasureTime frameDescription
Motor block appearing timeOn the operation dayTime (minutes) to complete motor block in the lower extremity after spinal anesthesia
Sensorial block appearing timeOn the operation dayTime (minutes) to complete sensorial block in the lower extremity after spinal anesthesia
Motor block disappearing timeOn the operation dayTime (minutes) to disappearance of complete motor block in the lower extremity after spinal anesthesia
Sensorial block disappearing timeOn the operation dayTime (minutes) to disappearance of sensorial block in the lower extremity after spinal anesthesia

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026