Labor Analgesia
Conditions
Brief summary
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
OTHERNo Interventions.
No interventions.
Sponsors
University of British Columbia
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Informed consent | 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
| Measure | Time frame | Description |
|---|---|---|
| Procedure description | 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. |
| Additional labour analgesia options | 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. |
| Risks and complications | 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). |
| Anticipated effects | 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). |
| Patient information sheets | 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. |
Countries
Canada
Contacts
Primary ContactVit B Gunka, MD
Backup ContactJuliana Barrera, MD
Outcome results
None listed