Regional AnesthesiaNCT05067985
SARS-CoV-2 PANDEMIC AND FAILED SPINAL ANESTHESIA
An observational study of Regional Anesthesia and SARS-CoV2 Infection, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The investigators used a retrospective review of 251 SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) positive patients' cesarean section anesthesia to determine the rate of failed spinal anesthesia, management techniques for failed block, and risk factors that contribute to failure in this study. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Regional Anesthesia, SARS-CoV2 Infection
- What is being tested?
- covid 19 spinal anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 251 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2020to 12 Mar 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 43 years
- Women only
- No healthy volunteers
- Adult
Study population: we included records of spinal anesthesia performed on confirmed COVID 19 patients in the Ankara City Hospital between April 2020 and February 2021
Who may be able to join
- we included records of spinal anesthesia performed on confirmed COVID 19 patients in the Ankara City Hospital between April 2020 and February 2021
Who cannot join
- Patients who did not have their data gathered, or whose operation took more than 3 hours due to any reason, were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aygun Guler
Ankara, Type A Choice Below ..., 06810
About this study
Official title: SARS-CoV-2 PANDEMIC AND FAILED SPINAL ANESTHESIA: A NIGHTMARE
The investigators used a retrospective review of 251 SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) positive patients' cesarean section anesthesia to determine the rate of failed spinal anesthesia, management techniques for failed block, and risk factors that contribute to failure in this study.
Read the detailed description
All anesthesiologists face a challenge when it comes to the anesthesia of patients with coronavirus disease who are going to have a cesarian section. Patients' and healthcare personnel' safety should be prioritized. Non-emergent procedures in patients with respiratory infections, such as COVID-19 (Coronavirus disease 2019), should be postponed and rescheduled once the infection has been treated. However, some emergency treatments, such as cesarian section, cannot be postponed. So, for COVID 19 patients, which method should be used? According to past studies, the risk of maternal death is 16,7 times higher with general anesthesia than with regional anesthesia (1). Furthermore, general anesthesia, which requires aerosol-generating procedures such as ventilating and intubating patients, has a higher risk of respiratory problems during or after surgery than regional anesthesia. Earlier data on pregnant patients during the COVID 19 pandemic showed no difference in COVID 19-related mortality between pregnant and non-pregnant patients, but a recent study found that pregnancy is associated with a 70% greater risk of death. Another important point is that, when compared to those who are not exposed to tracheal intubation, the transfer of acute respiratory infection to a health care professional during tracheal intubation is 6.6 times higher.
For such reasons, the European and American Societies of Regional Anesthesia jointly issued COVID 19 recommendations stating that regional anesthesia should be preferred over general anesthesia whenever possible, and practice recommendations for regional anesthesia during the pandemic have already been published.
In addition, the American Society of Anesthesiologists and the Society for Obstetric Anesthesiology and Perinatology advise doctors to "consider using neuraxial methods rather than general anesthesia for most cesarian deliveries." In many facilities, single-shot spinal anesthesia is the preferred method for cesarian section. It delivers great anesthesia because of its ease of use, rapid onset of sensory and motor blockage, reliability, ease of mastering, and capacity to provide optimal surgical circumstances; it also minimizes the hazards of general anesthetic while enhancing partition satisfaction. In addition, when compared to general anesthesia, the risk of complications such intraoperative bleeding, surgical site infection, and postoperative pain is lower with spinal anesthesia.
In 1899, August Bier proclaimed spinal anesthesia to be a failure, stating, "Experienced professional, correct technique, single puncture, adequate CSF backflow, effective anesthetic agent!" So, why did it fail? -Capriciousness!!" Single shot spinal anesthesia failure may occur when the subarachnoid space is not reached, or analgesia is not sufficient for surgery after injection. The issue is that if anesthesia fails during COVID 19 procedures, we'll need to develop a new approach for supplementing anesthesia and analgesia cautiously, quickly, and meticulously.
Failed spinal anesthesia can be partial or complete. If anesthesia and analgesia are not achieved within ten minutes after successful intrathecal injection, the bupivacaine spinal anesthetic is regarded to have failed. Partial failure was defined as insufficient extent, quality, or duration of pharmacological action for that procedure, while complete failure was described as no sensory or motor blockage.
Failure of spinal anesthesia necessitates extreme caution, judgment, and technique. If surgery has not yet begun, a partial or total failure can be managed by increasing the Trendelenburg position or administering a second spinal anesthetic. However, if the surgery has already begun, it can be managed by changing positions, injecting local anaesthetic in the operation area by the surgeon, administering sedation with oxygen, opioids, benzodiazepines, or ketamine, and then converting the anesthesia to general anesthesia.
The failure rate of spinal anesthesia is widely distributed, according to researches, ranging from 1 to 17 percent. During spinal anesthesia, the Royal College of Anesthetics proposes a failure rate of 3% in emergencies and 1% for elective procedures. The goal of this study was to determine failure rate and solutions for spinal anesthesia in the context of a COVID 19 pandemic.
- Conditions
- Regional Anesthesia, SARS-CoV2 Infection
- Being tested
- covid 19 spinal anesthesia
- Keywords
- regional anesthesia failure, regional anesthesia for SARS-CoV-2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
covid 19 spinal anesthesiaProcedure or surgery
this group description covers that all the covid 19 pregnant women which we gave spinal anesthesia for cesarean section procedures. The investigators analyzed them retrospectively.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 pregnant women | After receiving approval from the local ethics committee and permission to use the hospital archives, we included records of spinal anesthesia performed on confirmed SARS- CoV-2 patients in the Ankara City Hospital between April 2020 and February 2021, as well as related data, in our study. Patients who did not have their data gathered, or whose operation took more than 3 hours due to any reason, were excluded from the study Receives: Procedure: covid 19 spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of failed spinal block
the percentage of failed spinal anesthesia among SARS-CoV-2 positive pregnants who underwent cesarean section under spinal anesthesia
Measured: Between implementation of spinal anesthesia to the end of the surgery
Secondary outcomes (2)
reasons of failure of spinal block
possible reasons of inadequate spinal block among SARS-CoV-2 positive parturients who underwent cesarean section under spinal anesthesia
Measured: between implementation of spinal anesthesia to the end of the surgery
management of failed spinal anesthesia
anesthesia, sedation methods to manage failed spinal block for SARS-CoV-2 positive parturients who underwent cesarean section under spinal anesthesia
Measured: between implementation of spinal anesthesia to the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Apr 2020
- Primary completion28 Feb 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Regional AnesthesiaStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aygün Güler, md, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067985
- Sponsor's protocol ID
- 72300690-799
- Status last verified
- May 2021
- First submitted
- 7 Jul 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- Individual data sharing
- No
Publications
Warren J, Sundaram K, Anis H, Kamath AF, Mont MA, Higuera CA, Piuzzi NS. Spinal Anesthesia Is Associated With Decreased Complications After Total Knee and Hip Arthroplasty. J Am Acad Orthop Surg. 2020 Mar 1;28(5):e213-e221. doi: 10.5435/JAAOS-D-19-00156.
PubMed 31478916Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c.
PubMed 22713634Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
PubMed 11118174Zambrano LD, Ellington S, Strid P, Galang RR, Oduyebo T, Tong VT, Woodworth KR, Nahabedian JF 3rd, Azziz-Baumgartner E, Gilboa SM, Meaney-Delman D; CDC COVID-19 Response Pregnancy and Infant Linked Outcomes Team. Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status - United States, January 22-October 3, 2020. MMWR Morb Mortal Wkly Rep. 2020 Nov 6;69(44):1641-1647. doi: 10.15585/mmwr.mm6944e3.
PubMed 33151921Tran K, Cimon K, Severn M, Pessoa-Silva CL, Conly J. Aerosol generating procedures and risk of transmission of acute respiratory infections to healthcare workers: a systematic review. PLoS One. 2012;7(4):e35797. doi: 10.1371/journal.pone.0035797. Epub 2012 Apr 26.
PubMed 22563403Cobb BT, Lane-Fall MB, Month RC, Onuoha OC, Srinivas SK, Neuman MD. Anesthesiologist Specialization and Use of General Anesthesia for Cesarean Delivery. Anesthesiology. 2019 Feb;130(2):237-246. doi: 10.1097/ALN.0000000000002534.
PubMed 30601216Sng BL, Lim Y, Sia AT. An observational prospective cohort study of incidence and characteristics of failed spinal anaesthesia for caesarean section. Int J Obstet Anesth. 2009 Jul;18(3):237-41. doi: 10.1016/j.ijoa.2009.01.010. Epub 2009 May 17.
PubMed 19450971Shrestha AB, Shrestha CK, Sharma KR, Neupane B. Failure of subarachnoid block in caesarean section. Nepal Med Coll J. 2009 Mar;11(1):50-1.
PubMed 19769239Levy JH, Islas JA, Ghia JN, Turnbull C. A retrospective study of the incidence and causes of failed spinal anesthetics in a university hospital. Anesth Analg. 1985 Jul;64(7):705-10.
PubMed 4014732Fuzier R, Bataille B, Fuzier V, Richez AS, Magues JP, Choquet O, Montastruc JL, Lapeyre-Mestre M. Spinal anesthesia failure after local anesthetic injection into cerebrospinal fluid: a multicenter prospective analysis of its incidence and related risk factors in 1214 patients. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):322-6. doi: 10.1097/AAP.0b013e318217a68e.
PubMed 21701265van Dillen J, Diesch M, Schutte J, Zwart J, Wolterbeek R, van Roosmalen J. Comparing grades of urgency for classification of cesarean delivery. Int J Gynaecol Obstet. 2009 Oct;107(1):16-8. doi: 10.1016/j.ijgo.2009.05.001. Epub 2009 May 27.
PubMed 19477442Lucas DN, Yentis SM, Kinsella SM, Holdcroft A, May AE, Wee M, Robinson PN. Urgency of caesarean section: a new classification. J R Soc Med. 2000 Jul;93(7):346-50. doi: 10.1177/014107680009300703.
PubMed 10928020Kinsella SM. A prospective audit of regional anaesthesia failure in 5080 Caesarean sections. Anaesthesia. 2008 Aug;63(8):822-32. doi: 10.1111/j.1365-2044.2008.05499.x. Epub 2008 Jun 28.
PubMed 18547291Rukewe A, Adebayo OK, Fatiregun AA. Failed Obstetric Spinal Anesthesia in a Nigerian Teaching Hospital: Incidence and Risk Factors. Anesth Analg. 2015 Nov;121(5):1301-5. doi: 10.1213/ANE.0000000000000868.
PubMed 26218861Garry M, Davies S. Failure of regional blockade for caesarean section. Int J Obstet Anesth. 2002 Jan;11(1):9-12. doi: 10.1054/ijoa.2001.0903.
PubMed 15321571
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARS-CoV-2 PANDEMIC AND FAILED SPINAL ANESTHESIA: A NIGHTMARE
- ClinicalTrials.gov ID
- NCT05067985
- Acronym / sponsor ID
- 72300690-799
- Conditions
- Regional Anesthesia, SARS-CoV2 Infection
- Keywords
- regional anesthesia failure, regional anesthesia for SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 5 Oct 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 investigators used a retrospective review of 251 SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) positive patients' cesarean section anesthesia to determine the rate of failed spinal anesthesia, management techniques for failed block, and risk factors that contribute to failure in this study.
Detailed description
All anesthesiologists face a challenge when it comes to the anesthesia of patients with coronavirus disease who are going to have a cesarian section. Patients' and healthcare personnel' safety should be prioritized. Non-emergent procedures in patients with respiratory infections, such as COVID-19 (Coronavirus disease 2019), should be postponed and rescheduled once the infection has been treated. However, some emergency treatments, such as cesarian section, cannot be postponed. So, for COVID 19 patients, which method should be used? According to past studies, the risk of maternal death is 16,7 times higher with general anesthesia than with regional anesthesia (1). Furthermore, general anesthesia, which requires aerosol-generating procedures such as ventilating and intubating patients, has a higher risk of respiratory problems during or after surgery than regional anesthesia. Earlier data on pregnant patients during the COVID 19 pandemic showed no difference in COVID 19-related mortality between pregnant and non-pregnant patients, but a recent study found that pregnancy is associated with a 70% greater risk of death. Another important point is that, when compared to those who are not exposed to tracheal intubation, the transfer of acute respiratory infection to a health care professional during tracheal intubation is 6.6 times higher.
For such reasons, the European and American Societies of Regional Anesthesia jointly issued COVID 19 recommendations stating that regional anesthesia should be preferred over general anesthesia whenever possible, and practice recommendations for regional anesthesia during the pandemic have already been published.
In addition, the American Society of Anesthesiologists and the Society for Obstetric Anesthesiology and Perinatology advise doctors to "consider using neuraxial methods rather than general anesthesia for most cesarian deliveries." In many facilities, single-shot spinal anesthesia is the preferred method for cesarian section. It delivers great anesthesia because of its ease of use, rapid onset of sensory and motor blockage, reliability, ease of mastering, and capacity to provide optimal surgical circumstances; it also minimizes the hazards of general anesthetic while enhancing partition satisfaction. In addition, when compared to general anesthesia, the risk of complications such intraoperative bleeding, surgical site infection, and postoperative pain is lower with spinal anesthesia.
In 1899, August Bier proclaimed spinal anesthesia to be a failure, stating, "Experienced professional, correct technique, single puncture, adequate CSF backflow, effective anesthetic agent!" So, why did it fail? -Capriciousness!!" Single shot spinal anesthesia failure may occur when the subarachnoid space is not reached, or analgesia is not sufficient for surgery after injection. The issue is that if anesthesia fails during COVID 19 procedures, we'll need to develop a new approach for supplementing anesthesia and analgesia cautiously, quickly, and meticulously.
Failed spinal anesthesia can be partial or complete. If anesthesia and analgesia are not achieved within ten minutes after successful intrathecal injection, the bupivacaine spinal anesthetic is regarded to have failed. Partial failure was defined as insufficient extent, quality, or duration of pharmacological action for that procedure, while complete failure was described as no sensory or motor blockage.
Failure of spinal anesthesia necessitates extreme caution, judgment, and technique. If surgery has not yet begun, a partial or total failure can be managed by increasing the Trendelenburg position or administering a second spinal anesthetic. However, if the surgery has already begun, it can be managed by changing positions, injecting local anaesthetic in the operation area by the surgeon, administering sedation with oxygen, opioids, benzodiazepines, or ketamine, and then converting the anesthesia to general anesthesia.
The failure rate of spinal anesthesia is widely distributed, according to researches, ranging from 1 to 17 percent. During spinal anesthesia, the Royal College of Anesthetics proposes a failure rate of 3% in emergencies and 1% for elective procedures. The goal of this study was to determine failure rate and solutions for spinal anesthesia in the context of a COVID 19 pandemic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 pregnant women | – | Procedure: covid 19 spinal anesthesiaAfter receiving approval from the local ethics committee and permission to use the hospital archives, we included records of spinal anesthesia performed on confirmed SARS- CoV-2 patients in the Ankara City Hospital between April 2020 and February 2021, as well as related data, in our study. Patients who did not have their data gathered, or whose operation took more than 3 hours due to any reason, were excluded from the study |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- we included records of spinal anesthesia performed on confirmed COVID 19 patients in the Ankara City Hospital between April 2020 and February 2021
Key inclusion criteria (1 listed)
- we included records of spinal anesthesia performed on confirmed COVID 19 patients in the Ankara City Hospital between April 2020 and February 2021
Key exclusion criteria (1 listed)
- Patients who did not have their data gathered, or whose operation took more than 3 hours due to any reason, were excluded from the study.
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 |
|---|---|---|
| covid 19 spinal anesthesiathis group description covers that all the covid 19 pregnant women which we gave spinal anesthesia for cesarean section procedures. The investigators analyzed them retrospectively. | Procedure or surgery | SARS-CoV-2 pregnant women |
Primary outcome
The percentage of failed spinal block
Time frame: Between implementation of spinal anesthesia to the end of the surgery
the percentage of failed spinal anesthesia among SARS-CoV-2 positive pregnants who underwent cesarean section under spinal anesthesia
2 secondary outcomes
reasons of failure of spinal block
Time frame: between implementation of spinal anesthesia to the end of the surgery
management of failed spinal anesthesia
Time frame: between implementation of spinal anesthesia to the end of the surgery
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 25 Oct 2021.
- Background: PubMed 31478916Warren J, Sundaram K, Anis H, Kamath AF, Mont MA, Higuera CA, Piuzzi NS. Spinal Anesthesia Is Associated With Decreased Complications After Total Knee and Hip Arthroplasty. J Am Acad Orthop Surg. 2020 Mar 1;28(5):e213-e221. doi: 10.5435/JAAOS-D-19-00156.
- Background: PubMed 22713634Neuman MD, Silber JH, Elkassabany NM, Ludwig JM, Fleisher LA. Comparative effectiveness of regional versus general anesthesia for hip fracture surgery in adults. Anesthesiology. 2012 Jul;117(1):72-92. doi: 10.1097/ALN.0b013e3182545e7c.
- Background: PubMed 11118174Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.
- Background: PubMed 33151921Zambrano LD, Ellington S, Strid P, Galang RR, Oduyebo T, Tong VT, Woodworth KR, Nahabedian JF 3rd, Azziz-Baumgartner E, Gilboa SM, Meaney-Delman D; CDC COVID-19 Response Pregnancy and Infant Linked Outcomes Team. Update: Characteristics of Symptomatic Women of Reproductive Age with Laboratory-Confirmed SARS-CoV-2 Infection by Pregnancy Status - United States, January 22-October 3, 2020. MMWR Morb Mortal Wkly Rep. 2020 Nov 6;69(44):1641-1647. doi: 10.15585/mmwr.mm6944e3.
- Background: PubMed 22563403Tran K, Cimon K, Severn M, Pessoa-Silva CL, Conly J. Aerosol generating procedures and risk of transmission of acute respiratory infections to healthcare workers: a systematic review. PLoS One. 2012;7(4):e35797. doi: 10.1371/journal.pone.0035797. Epub 2012 Apr 26.
- Background: PubMed 30601216Cobb BT, Lane-Fall MB, Month RC, Onuoha OC, Srinivas SK, Neuman MD. Anesthesiologist Specialization and Use of General Anesthesia for Cesarean Delivery. Anesthesiology. 2019 Feb;130(2):237-246. doi: 10.1097/ALN.0000000000002534.
- Background: PubMed 19450971Sng BL, Lim Y, Sia AT. An observational prospective cohort study of incidence and characteristics of failed spinal anaesthesia for caesarean section. Int J Obstet Anesth. 2009 Jul;18(3):237-41. doi: 10.1016/j.ijoa.2009.01.010. Epub 2009 May 17.
- Background: PubMed 19769239Shrestha AB, Shrestha CK, Sharma KR, Neupane B. Failure of subarachnoid block in caesarean section. Nepal Med Coll J. 2009 Mar;11(1):50-1.
- Background: PubMed 4014732Levy JH, Islas JA, Ghia JN, Turnbull C. A retrospective study of the incidence and causes of failed spinal anesthetics in a university hospital. Anesth Analg. 1985 Jul;64(7):705-10.
- Background: PubMed 21701265Fuzier R, Bataille B, Fuzier V, Richez AS, Magues JP, Choquet O, Montastruc JL, Lapeyre-Mestre M. Spinal anesthesia failure after local anesthetic injection into cerebrospinal fluid: a multicenter prospective analysis of its incidence and related risk factors in 1214 patients. Reg Anesth Pain Med. 2011 Jul-Aug;36(4):322-6. doi: 10.1097/AAP.0b013e318217a68e.
- Background: PubMed 19477442van Dillen J, Diesch M, Schutte J, Zwart J, Wolterbeek R, van Roosmalen J. Comparing grades of urgency for classification of cesarean delivery. Int J Gynaecol Obstet. 2009 Oct;107(1):16-8. doi: 10.1016/j.ijgo.2009.05.001. Epub 2009 May 27.
- Background: PubMed 10928020Lucas DN, Yentis SM, Kinsella SM, Holdcroft A, May AE, Wee M, Robinson PN. Urgency of caesarean section: a new classification. J R Soc Med. 2000 Jul;93(7):346-50. doi: 10.1177/014107680009300703.
- Individual participant dataSharing planned: No
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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.
Aygün Güler, md principal investigator
Ankara City Hospital Bilkent
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 Regional Anesthesia and SARS-CoV2 Infection, run by Ankara City Hospital Bilkent 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 1 inclusion and 1 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 25 Oct 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?
The percentage of failed spinal block (time frame: Between implementation of spinal anesthesia to the end of the surgery). 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 NCT05067985, which also lists 22 linked publications.
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 25 Oct 2021.