Labor AnalgesiaACP-LNANCT07083167
Anesthesia Clinical Practice During Labour Neuraxial Analgesia
An observational study of Labor Analgesia, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Labor Analgesia
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 2 Apr 2025to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All obstetric anesthesiologists working in maternity unit
Who may be able to join
- all obstetric anesthesiologists working in maternity unit
Who cannot join
- any comorbidity of the patient that would necessitate deviation from a routine practice for the initiation of labor neuraxial analgesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Department of Anesthesia at BC Women's Hospital, University of British Columbia.
Vancouver, British Columbia, V6H 3N1
Vit B Gunka, MD, 604-875-6078, vgunka@cw.bc.ca
Juliana Barrera, MD, 604-875-6076, juliana.barrera@cw.bc.ca
About this study
Official title: Anesthesia Clinical Practice During Labour Neuraxial Analgesia: A Prospective Observational Study
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.
- Conditions
- Labor Analgesia
- Being tested
- No Interventions.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Interventions.Other
No interventions.
| Study group | Role | What they receive |
|---|---|---|
| Anesthesiologists | All anesthesiologists providing labor neuraxial analgesia Receives: Other: No Interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the first contact with the patient before labour neuraxial analgesia until the procedure is finished.
Secondary outcomes (5)
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.
Measured: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial anesthesia.
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.
Measured: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.
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).
Measured: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.
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).
Measured: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.
Patient information sheets
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.
Measured: During the standard clinical consent process provided to patients prior to the administration of labour neuraxial analgesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start2 Apr 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Labor AnalgesiaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vit Gunka, University of British Columbia
- Investigators
- Vit B Gunka, MD, Principal investigator, Department of Anesthesia at BC Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083167
- Sponsor's protocol ID
- H24-03381 ACP-LNA
- Acronym
- ACP-LNA
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27988961Tait 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.
PubMed 24898765Pattee 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.
PubMed 9305553Anim-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.
PubMed 29781504
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia Clinical Practice During Labour Neuraxial Analgesia: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07083167
- Acronym / sponsor ID
- ACP-LNA / H24-03381 ACP-LNA
- Conditions
- Labor Analgesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthesiologists | – | Other: No Interventions.All anesthesiologists providing labor neuraxial analgesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All obstetric anesthesiologists working in maternity unit
Key inclusion criteria (1 listed)
- all obstetric anesthesiologists working in maternity unit
Key exclusion criteria (1 listed)
- any comorbidity of the patient that would necessitate deviation from a routine practice for the initiation of labor neuraxial analgesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Interventions.No interventions. | Other | Anesthesiologists |
Primary outcome
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).
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Results publication: PubMed 27988961Yentis 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.
- Results publication: PubMed 24898765Tait 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.
- Results publication: PubMed 9305553Pattee 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.
- Results publication: PubMed 29781504Anim-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vit B Gunka, MD principal investigator
Department of Anesthesia at BC Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Analgesia, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vit B Gunka, MD (604-875-6078, vgunka@cw.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informed consent (time frame: From the first contact with the patient before labour neuraxial analgesia until the procedure is finished.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07083167, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.