NCT Number: NCT07083167
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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Observational
Vancouver, British Columbia, V6H 3N1, Canada
Location status: Recruiting
Aislynn Sharrock, BA (Hons.)
SUB_INVESTIGATOR
Juliana Barrera, MD
CONTACT
Juliana Barrera, MD
SUB_INVESTIGATOR
Maisa Samiee, BSc candidate
SUB_INVESTIGATOR
Simon Massey, MB BCh
SUB_INVESTIGATOR
Vit B Gunka, MD
CONTACT
Vit B Gunka, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No interventions.
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).
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.
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.
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).
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).
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.
Contact information is provided by the study sponsor or research team.
Juliana Barrera, MD
CONTACT
Vit B Gunka, MD
CONTACT
University of British Columbia
Other
Anesthesia Clinical Practice During Labour Neuraxial Analgesia: A Prospective Observational Study
Acronym: ACP-LNA
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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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