Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia

Ankara Etlik City Hospital

Status: Completed

Conditions: Ambulatory Surgery; Spinal Anesthesia; Discharge Time

Treatments: Procedure: 4 mg bupivacaine; Procedure: 6 mg bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06527430

AEŞH-EK1-2024-0074

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Spinal anesthesia with 4 mg bupivacaine

Active Comparator group

Description:

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.

Treatment:

Procedure: 4 mg bupivacaine

Spinal anesthesia with 6 mg bupivacaine

Active Comparator group

Description:

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.

Treatment:

Procedure: 6 mg bupivacaine