NCT05067985

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
251

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 5, 2021

Completed
Last Updated

October 25, 2021

Status Verified

May 1, 2021

Enrollment Period

11 months

First QC Date

July 7, 2021

Last Update Submit

October 18, 2021

Conditions

Keywords

regional anesthesia failureregional anesthesia for SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • reasons of failure of spinal block

    between implementation of spinal anesthesia to the end of the surgery

  • management of failed spinal anesthesia

    between implementation of spinal anesthesia to the end of the surgery

Study Arms (1)

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

Procedure: covid 19 spinal anesthesia

Interventions

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.

SARS-CoV-2 pregnant women

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsall the cesarean section patients included for study
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aygun Guler

Ankara, Type A Choice Below ..., 06810, Turkey (Türkiye)

Location

Related Publications (22)

  • 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.

    PMID: 31478916BACKGROUND
  • Neuman 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.

    PMID: 22713634BACKGROUND
  • Rodgers 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.

    PMID: 11118174BACKGROUND
  • Zambrano 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.

    PMID: 33151921BACKGROUND
  • Tran 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.

    PMID: 22563403BACKGROUND
  • 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.

    PMID: 30601216BACKGROUND
  • 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.

    PMID: 19450971BACKGROUND
  • Shrestha AB, Shrestha CK, Sharma KR, Neupane B. Failure of subarachnoid block in caesarean section. Nepal Med Coll J. 2009 Mar;11(1):50-1.

    PMID: 19769239BACKGROUND
  • Levy 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.

    PMID: 4014732BACKGROUND
  • Fuzier 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.

    PMID: 21701265BACKGROUND
  • van 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.

    PMID: 19477442BACKGROUND
  • Lucas 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.

    PMID: 10928020BACKGROUND
  • Kinsella 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.

    PMID: 18547291BACKGROUND
  • Rukewe 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.

    PMID: 26218861BACKGROUND
  • Garry 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.

    PMID: 15321571BACKGROUND
  • 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. No abstract available.

    PMID: 32659378BACKGROUND
  • Agarwal A, Agarwal S, Motiani P. Difficulties Encountered While Using PPE Kits and How to Overcome Them: An Indian Perspective. Cureus. 2020 Nov 23;12(11):e11652. doi: 10.7759/cureus.11652.

    PMID: 33251079BACKGROUND
  • Adesope OA, Einhorn LM, Olufolabi AJ, Cooter M, Habib AS. The impact of gestational age and fetal weight on the risk of failure of spinal anesthesia for cesarean delivery. Int J Obstet Anesth. 2016 May;26:8-14. doi: 10.1016/j.ijoa.2016.01.007. Epub 2016 Feb 2.

    PMID: 27020240BACKGROUND
  • Sharma SK, Gambling DR, Joshi GP, Sidawi JE, Herrera ER. Comparison of 26-gauge Atraucan and 25-gauge Whitacre needles: insertion characteristics and complications. Can J Anaesth. 1995 Aug;42(8):706-10. doi: 10.1007/BF03012669.

    PMID: 7586110BACKGROUND
  • Arevalo-Rodriguez I, Munoz L, Godoy-Casasbuenas N, Ciapponi A, Arevalo JJ, Boogaard S, Roque I Figuls M. Needle gauge and tip designs for preventing post-dural puncture headache (PDPH). Cochrane Database Syst Rev. 2017 Apr 7;4(4):CD010807. doi: 10.1002/14651858.CD010807.pub2.

    PMID: 28388808BACKGROUND
  • Drasner K, Rigler ML. Repeat injection after a "failed spinal": at times, a potentially unsafe practice. Anesthesiology. 1991 Oct;75(4):713-4. No abstract available.

    PMID: 1817478BACKGROUND
  • 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.

    PMID: 19329469BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Aygün Güler, md

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2021

First Posted

October 5, 2021

Study Start

April 1, 2020

Primary Completion

February 28, 2021

Study Completion

March 12, 2021

Last Updated

October 25, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations