SARS-CoV-2 PANDEMIC AND FAILED SPINAL ANESTHESIA

SARS-CoV2 Infection Clinical Trial

Official title:

SARS-CoV-2 PANDEMIC AND FAILED SPINAL ANESTHESIA: A NIGHTMARE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05067985
• Other study ID #: 72300690-799
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: March 12, 2021

Study information

• Verified date: May 2021
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: March 12, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• we included records of spinal anesthesia performed on confirmed COVID 19 patients in the Ankara City Hospital between April 2020 and February 2021

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19
• Regional Anesthesia
• SARS-CoV2 Infection

Intervention

Procedure:
• covid 19 spinal anesthesia
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.

Locations

Country	Name	City	State
Turkey	Aygun Guler	Ankara	Type A Choice Below ...

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (22)

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Cobb 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. — View Citation

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Sng 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. — View Citation

Steiner LA, Hauenstein L, Ruppen W, Hampl KF, Seeberger MD. Bupivacaine concentrations in lumbar cerebrospinal fluid in patients with failed spinal anaesthesia. Br J Anaesth. 2009 Jun;102(6):839-44. doi: 10.1093/bja/aep050. Epub 2009 Mar 26. — View Citation

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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. — View Citation

Wu J, Chen X, Yao S, Liu R. Anxiety persists after recovery from acquired COVID-19 in anaesthesiologists. J Clin Anesth. 2020 Dec;67:109984. doi: 10.1016/j.jclinane.2020.109984. Epub 2020 Jul 7. — View Citation

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Between implementation of spinal anesthesia to the end of the surgery
Secondary	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	between implementation of spinal anesthesia to the end of the surgery
Secondary	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	between implementation of spinal anesthesia to the end of the surgery