Anesthesia Clinical Practice During Labour Neuraxial Analgesia
ConditionLabor Analgesia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of British Columbia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
all obstetric anesthesiologists working in maternity unit
Disqualifiers
any comorbidity of the patient that would necessitate deviation from a routine practice for the initiation of labor neuraxial analgesia
Trial population
All obstetric anesthesiologists working in maternity unit
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Interventions.
Other interventionNo interventions.
Treatment groups
19 Participants
are divided into 1 treatment groupGroup A: Anesthesiologists1 intervention
Trial outcomes
Primary outcomes
1
Informed consent
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
From the first contact with the patient before labour neuraxial analgesia until the procedure is finished.Secondary outcomes
1
Procedure description
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 anesthesia.2
Additional labour analgesia options
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.3
Risks and complications
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.4
Anticipated effects
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.Sponsors and contacts
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Source ClinicalTrials.gov