Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia

NCT06527430 | Completed

• 1 other identifier: AEŞH-EK1-2024-0074
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Discharge Time; Ambulatory Surgery; Spinal Anesthesia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Motor block appearing time

  On the operation day

• Sensorial block appearing time

  On the operation day

• Motor block disappearing time

  On the operation day

• Sensorial block disappearing time

  On the operation day

Study Arms (2)

Spinal anesthesia with 4 mg bupivacaine

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.

Procedure: 4 mg bupivacaine

Spinal anesthesia with 6 mg bupivacaine

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.

Procedure: 6 mg bupivacaine

Interventions

4 mg bupivacaine PROCEDURE

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

Spinal anesthesia with 4 mg bupivacaine

6 mg bupivacaine PROCEDURE

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

Spinal anesthesia with 6 mg bupivacaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 30, 2024
• Study Start: July 30, 2024
• Primary Completion: May 10, 2025
• Study Completion: May 30, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Locations

TU (1)