Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-30

Study Completion Date

2025-05-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Discharge Time Ambulatory Surgery Spinal Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

4 mg bupivacaine

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

6 mg bupivacaine

Intervention Type PROCEDURE

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

Interventions

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4 mg bupivacaine

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

Intervention Type PROCEDURE

6 mg bupivacaine

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No