The Impact of Fasting Duration on Quality of Recovery After Cesarean Section

NCT ID: NCT06701929

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-18

Study Completion Date

2026-06-01

Brief Summary

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This study will evaluate the effect of fasting duration and elective c-section start time on the overall quality of recovery. Patients will be seen 24 hours after surgery to answer 11 questions on their overall recovery after surgery. Several factors will be tracked to determine their effect on recovery, with the primary variable of interesting

Detailed Description

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This is a prospective observational study aiming to evaluate the impact of fasting time before cesarean section on the quality of recovery after c-section. All patients presenting for elective cesarean section with low transverse incision, under spinal anesthesia will be considered for inclusion.

The primary outcome will be the ObsQoR-11 score approximately 24 hours after surgery. Secondary outcomes will include the presence of nausea, vomiting or retching during surgery, the volume of intravenous fluid administered, the dose of vasopressor administered, the pain scores two hours after surgery, and the dose of opioid used in the 24 hours after surgery.

The primary analysis will be a linear regression to determine if there is a statistically significant correlation between fasting time and the ObsQoR-11 score while factoring in the variables mentioned above. Secondary analyses will determine if the fasting duration correlates with a change in any of the eleven components of the ObsQoR-11 score or the secondary outcomes listed. In addition, the fasting data will be plotted against the ObsQoR-11 score to determine if an inflection point is present.

Ten observations will be obtained for each independent variable included in the model, for a total of 100 patients in the study.

Conditions

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Quality Improvement Quality of Recovery From Anaesthesia Cesarean Section Fasting ( 6H for Solid ; 2H for Clear Fluid )

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Presenting for elective c-section under spinal anesthesia

Exclusion Criteria

* Unable to communicate in French or English
* Urgent c-section
* Planned general anesthesia
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Jewish General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Matthew Cameron, MDCM MPH

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jewish General Hospital

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Matthew Cameron, MDCM MPH

Role: CONTACT

514-340-8222 ext. 25701

Facility Contacts

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Mattheq Cameron, MDCM MPH FRCPC

Role: primary

514-340-8222 ext. 25701

References

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Kielty J, Borkowska A, Lawlor E, El-Khuffash AF, Doherty A, O'Flaherty D. Use of the Obstetric Quality-of-Recovery score (ObsQoR-11) to measure the impact of an enhanced recovery programme for elective caesarean section. Int J Obstet Anesth. 2024 Feb;57:103955. doi: 10.1016/j.ijoa.2023.103955. Epub 2023 Nov 10.

Reference Type BACKGROUND
PMID: 38030526 (View on PubMed)

Bollag L, Lim G, Sultan P, Habib AS, Landau R, Zakowski M, Tiouririne M, Bhambhani S, Carvalho B. Society for Obstetric Anesthesia and Perinatology: Consensus Statement and Recommendations for Enhanced Recovery After Cesarean. Anesth Analg. 2021 May 1;132(5):1362-1377. doi: 10.1213/ANE.0000000000005257.

Reference Type BACKGROUND
PMID: 33177330 (View on PubMed)

Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.

Reference Type BACKGROUND
PMID: 30579408 (View on PubMed)

Other Identifiers

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ObsQoR-11 Survey (2025-4422)

Identifier Type: -

Identifier Source: org_study_id

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