Discharge TimeNCT06527430
Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia
A study testing 4 mg bupivacaine and 6 mg bupivacaine in people with Discharge Time and Ambulatory Surgery, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Discharge Time, Ambulatory Surgery, Spinal Anesthesia
- What is being tested?
- 4 mg bupivacaine and 6 mg bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
About this study
Official title: Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia in Varicose Vein Surgery
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
- Being tested
- 4 mg bupivacaine, 6 mg bupivacaine
- Keywords
- local anesthetic volume, varicose vein surgery, ambulatory surgery, spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 mg bupivacaineProcedure or surgery
Spinal anesthesia was applied to the patients with 4 mg bupivacaine in the lateral decubitus position.
6 mg bupivacaineProcedure or surgery
Spinal anesthesia was applied to the patients with 6 mg bupivacaine in the lateral decubitus position.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: 6 mg bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge time
The time (minutes) from the application of spinal anesthesia to the patients' discharge will be recorded as the discharge period.
Measured: On the operation day
Secondary outcomes (4)
Motor block appearing time
Time (minutes) to complete motor block in the lower extremity after spinal anesthesia
Measured: On the operation day
Sensorial block appearing time
Time (minutes) to complete sensorial block in the lower extremity after spinal anesthesia
Measured: On the operation day
Motor block disappearing time
Time (minutes) to disappearance of complete motor block in the lower extremity after spinal anesthesia
Measured: On the operation day
Sensorial block disappearing time
Time (minutes) to disappearance of sensorial block in the lower extremity after spinal anesthesia
Measured: On the operation day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start30 Jul 2024
- Primary completion10 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Discharge TimeStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Atakan Sezgi, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527430
- Sponsor's protocol ID
- AEŞH-EK1-2024-0074
- Status last verified
- Jun 2025
- First submitted
- 25 Jul 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sezgi A, Zengin M, Hekimoglu S, Taskir Turan M, Topcu I, Arik E, Cakmak EK, Ozdemir Sezgi ES, Kina SF, Ergil J. Different local anesthetic volumes for unilateral spinal anesthesia in varicose vein surgery prospective randomized clinical trial. BMC Anesthesiol. 2026 Jan 10;26(1):95. doi: 10.1186/s12871-026-03619-z.
PubMed 41519711
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Local Anesthetic Volumes for Unilateral Spinal Anesthesia in Varicose Vein Surgery
- ClinicalTrials.gov ID
- NCT06527430
- Acronym / sponsor ID
- AEŞH-EK1-2024-0074
- Conditions
- Discharge Time, Ambulatory Surgery, Spinal Anesthesia
- Keywords
- local anesthetic volume, varicose vein surgery, ambulatory surgery, spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia with 4 mg bupivacaine | Active comparator | Procedure: 4 mg bupivacaineAfter 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. |
| Spinal anesthesia with 6 mg bupivacaine | Active comparator | Procedure: 6 mg bupivacaineAfter 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4 mg bupivacaineSpinal anesthesia was applied to the patients with 4 mg bupivacaine in the lateral decubitus position. | Procedure or surgery | Spinal anesthesia with 4 mg bupivacaine |
| 6 mg bupivacaineSpinal anesthesia was applied to the patients with 6 mg bupivacaine in the lateral decubitus position. | Procedure or surgery | Spinal anesthesia with 6 mg bupivacaine |
Primary outcome
Discharge time
Time frame: On the operation day
The time (minutes) from the application of spinal anesthesia to the patients' discharge will be recorded as the discharge period.
4 secondary outcomes
Motor block appearing time
Time frame: On the operation day
Sensorial block appearing time
Time frame: On the operation day
Motor block disappearing time
Time frame: On the operation day
Sensorial block disappearing time
Time frame: On the operation day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Derived from this study: PubMed 41519711Sezgi A, Zengin M, Hekimoglu S, Taskir Turan M, Topcu I, Arik E, Cakmak EK, Ozdemir Sezgi ES, Kina SF, Ergil J. Different local anesthetic volumes for unilateral spinal anesthesia in varicose vein surgery prospective randomized clinical trial. BMC Anesthesiol. 2026 Jan 10;26(1):95. doi: 10.1186/s12871-026-03619-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 mg bupivacaine and 6 mg bupivacaine in people with Discharge Time and Ambulatory Surgery, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge time (time frame: On the operation day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06527430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.