Anesthesia Clinical Practice During Labour Neuraxial Analgesia

NCT07083167 | Recruiting

• 1 other identifier: H24-03381 ACP-LNA
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Analgesia

Outcome Measures

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).

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

Secondary Outcomes (5)

• Procedure description

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

• Additional labour analgesia options

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

• Risks and complications

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

• Anticipated effects

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

• Patient information sheets

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

Study Arms (1)

Anesthesiologists

All anesthesiologists providing labor neuraxial analgesia

Other: No Interventions.

Interventions

No Interventions. OTHER

No interventions.

Anesthesiologists

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All obstetric anesthesiologists working in maternity unit

You may qualify if:

• all obstetric anesthesiologists working in maternity unit

You may not qualify if:

• any comorbidity of the patient that would necessitate deviation from a routine practice for the initiation of labor neuraxial analgesia

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

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

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

Related Publications (4)

• 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.

  PMID: 27988961 BACKGROUND

• Tait 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.

  PMID: 24898765 BACKGROUND

• Pattee 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.

  PMID: 9305553 BACKGROUND

• Anim-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.

  PMID: 29781504 BACKGROUND

Study Officials

• Vit B Gunka, MD

  Department of Anesthesia at BC Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vit B Gunka, MD

CONTACT

604-875-6078; vgunka@cw.bc.ca

Juliana Barrera, MD

CONTACT

604-875-6076; juliana.barrera@cw.bc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Principal Investigator

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 24, 2025
• Study Start: April 2, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)