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

How Fasting Duration Before Cesarean Section Affects the Quality of Recovery Score (ObsQoR-11)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06701929
Enrollment
100
Registered
2024-11-22
Start date
2025-03-18
Completion date
2026-10-31
Last updated
2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Quality of Recovery, cesarean section, fasting duration

Brief summary

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

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.

Interventions

None listed

Sponsors

Jewish General Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Obstetric Quality of Recovery (ObsQoR-11)3 monthsObstetric quality of recovery after c-section, which has been validated based on the total score of 11 questions, with total scores ranging from 0 to 110, where 0 is the worst, and 110 is the best.

Secondary

MeasureTime frameDescription
Nausea & Vomitting24 hoursThe presence of nausea vomiting or retching during or within 24 hours of surgery
Numeric Rating Scale (NRS) Pain Score 2 hours after surgery2 hours after surgeryRating of pain, on a scale where 0 is no pain, and 10 is the worst pain imaginable.

Countries

Canada

Contacts

CONTACTMatthew Cameron, MDCM MPH
matthew.cameron@mcgill.ca514-340-8222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 11, 2026