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NCT Number: NCT07083167

Anesthesia Clinical Practice During Labour Neuraxial Analgesia

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.

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Key information

Conditions

Labor Analgesia

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesia at BC Women's Hospital, University of British Columbia.

Vancouver, British Columbia, V6H 3N1, Canada

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No interventions.

Other

No interventions.

Primary outcomes

  1. Informed consent

    Time frame: From the first contact with the patient before labour neuraxial analgesia until the procedure is finished.

    Incidence of key elements (such as technique desciption, alternatives, risks, complications, and expected effects) during the consent process before the labour neuraxial analgesia procedure. This will be assessed using a structured observation checklist with dichotomous variables (yes/no).

Secondary outcomes

  1. Procedure description

    Time frame: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial anesthesia.

    Proportion of consent discussions in which the staff anesthesiologist described specific steps involved in administering labour neuraxial analgesia.

    Unit of measure: Percentage of specific consent discussions including each pre-defined procedural element using the data collection sheet (Appendix 3) during the observation of the consent process.

  2. Additional labour analgesia options

    Time frame: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.

    Proportion of specific consent discussions in which the staff anesthesiologist offered additional labour analgesia options. Unit of measure: percentage of specific consent discussions in which alternative analgesia options were offered using the data collection sheet (Appendix 3) to document whether alternatives were discussed and which options (if any) were offered.

  3. Risks and complications

    Time frame: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.

    Proportion of specific consent discussion in which specific risks and complications of labour neuraxial analgesia were mentioned and described to the patient in further detail. Unit of measure: percentage of specific consent discussions mentioning each risk; proportion thoroughly described versus briefly mentioned using the data collection sheet (Appendix 3).

  4. Anticipated effects

    Time frame: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.

    Proportion of specific consent discussions that included discussion of what the patient should expect after the labour neuraxial anesthesia procedure. Unit of measure: percentage of specific consent discussions where each anticipated effect was mentioned (pre- and/or post-procedure) using the data collection sheet (Appendix 3).

  5. Patient information sheets

    Time frame: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.

    Proportion of specific consent discussion in which the staff anesthesiologist being observed mentioned or offered the use of patient information sheets on labour neuraxial analgesia. Unit of measure: percentage of specific consent discussion involving the use or mention of an information sheet, which will be noted on the data collection sheet (Appendix 3) throughout the observed consent process.

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Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Acronym: ACP-LNA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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