PainNCT04706247
Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery
An observational study of Pain and Breast Diseases, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate the efficacy of the thoracic combined spinal epidural anesthesia in breast surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 months, women only
- Conditions the study is for
- Pain, Breast Diseases
- What is being tested?
- thoracic combined spinal epidural anesthesia
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Jan 2021to 17 May 2021
- Phase
- Observational
- 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 70 months
- Women only
- Child
Study population: Adults between 18-75 years of age and who will be to undergo elective breast surgery
Who may be able to join
- Patients who will be to undergo elective surgery for breast surgery
- American Society of Anesthesiologists (ASA) physical status classification groups I or II
Who cannot join
- body mass index>35 kg/m2,
- presence of any condition complicating and contraindicating spinal epidural anesthesia.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital
Antalya
About this study
Official title: Segmental High Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery
The aim of the study is to investigate the efficacy of the thoracic combined spinal epidural anesthesia in breast surgery.
Read the detailed description
Previous studies of the regional anesthetic techniques such as erector spinae plane block and pectoralis nerve blocks (PECs blocks) additional to general anesthesia have described their use for postoperative analgesia in breast surgery. It has been also reported that these blocks can be used to provide surgical anesthesia in breast surgery . Segmental thoracic epidural anesthesia can be used as an alternative anesthetic technique in patients with severe chronic obstructive pulmonary disease and asthma undergoing breast surgery. It has been also reported that thoracic spinal anesthesia was effective and successful in patients undergoing laparoscopic surgery. In this study, efficacy of high thoracic spinal epidural anesthesia in patients undergoing breast surgery will be evaluated.
- Conditions
- Pain, Breast Diseases
- Being tested
- thoracic combined spinal epidural anesthesia
- Medical subject headings
- Pain, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic combined spinal epidural anesthesiaOther
A combined spinal-epidural anesthesia set will be used for the block. Using the loss of resistance to saline technique, an 18 G Tuohy needle will be advanced to the T2-3 vertebral interspace with the mid-line approach. After confirming the epidural space, a 26 G pencil point spinal needle will be inserted slowly through the Tuohy needle to puncture the dura. After free flow of cerebrospinal fluid will be observed, local anesthetic wil be injected into the subarachnoid space over 15 secs. Then, an epidural catheter will be inserted into the epidural space.
What is being measured
The primary outcome is the main question the study is designed to answer.
Block success
the number of patients whose surgery was completed without general anesthesia
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start4 Jan 2021
- Primary completion13 Apr 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lutfi Ozyurek, M.D., Study director, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04706247
- Sponsor's protocol ID
- lutfi1
- Status last verified
- Jan 2021
- First submitted
- 10 Jan 2021
- Last updated
- 18 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmental High Thoracic Combined Spinal Epidural Anesthesia for Breast Surgery
- ClinicalTrials.gov ID
- NCT04706247
- Acronym / sponsor ID
- lutfi1
- Conditions
- Pain, Breast Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 13 Apr 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 12 Jan 2021 (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.
The aim of the study is to investigate the efficacy of the thoracic combined spinal epidural anesthesia in breast surgery.
Detailed description
Previous studies of the regional anesthetic techniques such as erector spinae plane block and pectoralis nerve blocks (PECs blocks) additional to general anesthesia have described their use for postoperative analgesia in breast surgery. It has been also reported that these blocks can be used to provide surgical anesthesia in breast surgery . Segmental thoracic epidural anesthesia can be used as an alternative anesthetic technique in patients with severe chronic obstructive pulmonary disease and asthma undergoing breast surgery. It has been also reported that thoracic spinal anesthesia was effective and successful in patients undergoing laparoscopic surgery. In this study, efficacy of high thoracic spinal epidural anesthesia in patients undergoing breast surgery will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 months
- Sex
- Female only
- Age groups
- Child
- Study population
- Adults between 18-75 years of age and who will be to undergo elective breast surgery
Key inclusion criteria (2 listed)
- Patients who will be to undergo elective surgery for breast surgery
- American Society of Anesthesiologists (ASA) physical status classification groups I or II
Key exclusion criteria (2 listed)
- body mass index>35 kg/m2,
- presence of any condition complicating and contraindicating spinal epidural anesthesia.
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 |
|---|---|---|
| thoracic combined spinal epidural anesthesiaA combined spinal-epidural anesthesia set will be used for the block. Using the loss of resistance to saline technique, an 18 G Tuohy needle will be advanced to the T2-3 vertebral interspace with the mid-line approach. After confirming the epidural space, a 26 G pencil point spinal needle will be inserted slowly through the Tuohy needle to puncture the dura. After free flow of cerebrospinal fluid will be observed, local anesthetic wil be injected into the subarachnoid space over 15 secs. Then, an epidural catheter will be inserted into the epidural space. | Other | – |
Primary outcome
Block success
Time frame: through study completion, an average of 3 months
the number of patients whose surgery was completed without general anesthesia
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 18 May 2021.
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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.
Lutfi Ozyurek, M.D. study director
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Breast Diseases, run by Antalya Training and Research 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 2 inclusion and 2 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 18 May 2021. 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?
Block success (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2021.