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Recruiting NCT07083167

Anesthesia Clinical Practice During Labour Neuraxial Analgesia

— Observational Labor Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Interventions..
Who it may be relevant to
Registry conditions: Labor Analgesia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Anesthesia Clinical Practice During Labour Neuraxial Analgesia: A Prospective Observational Study

Overview

The goal of this observational study is to evaluate the communication between the anesthesiologist and the patient prior the initiation and during the administration of the labor neuraxial analgesia. The investigators hypothesize that there will be differences among anesthesiologists during the informed consent process and communication during the procedure, specifically, how the anesthesiologists describe the technical aspects of the procedure, alternatives, risks, complications, and expected effects of labour neuraxial analgesia. The anesthesiologists will be observed during a routine labor neuraxial analgesia procedure for healthy uncomplicated patients.

Interventions

  • Other No Interventions.
    No interventions.

Primary outcome measures

  • Informed consent [Time frame: From the first contact with the patient before labour neuraxial analgesia until the procedure is finished.]
Secondary outcome measures (5)
  • Procedure description [Time frame: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial anesthesia.]
  • Additional labour analgesia options [Time frame: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.]
  • Risks and complications [Time frame: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.]
  • Anticipated effects [Time frame: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.]
  • Patient information sheets [Time frame: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.]

Eligibility criteria

Inclusion criteria

  • all obstetric anesthesiologists working in maternity unit

Exclusion criteria

  • any comorbidity of the patient that would necessitate deviation from a routine practice for the initiation of labor neuraxial analgesia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Canada · 1 center
  • Department of Anesthesia at BC Women's Hospital, University of British Columbia. — Vancouver

Publications

  • Yentis SM, Hartle AJ, Barker IR, Barker P, Bogod DG, Clutton-Brock TH, Ruck Keene A, Leifer S, Naughton A, Plunkett E. AAGBI: Consent for anaesthesia 2017: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2017 Jan;72(1):93-105. doi: 10.1111/anae.13762. PMID 27988961
  • Tait AR, Teig MK, Voepel-Lewis T. Informed consent for anesthesia: a review of practice and strategies for optimizing the consent process. Can J Anaesth. 2014 Sep;61(9):832-42. doi: 10.1007/s12630-014-0188-8. Epub 2014 Jun 5. PMID 24898765
  • Pattee C, Ballantyne M, Milne B. Epidural analgesia for labour and delivery: informed consent issues. Can J Anaesth. 1997 Sep;44(9):918-23. doi: 10.1007/BF03011961. PMID 9305553
  • Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4. PMID 29781504

Identifiers

NCT: NCT07083167 · H24-03381 ACP-LNA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗