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

Not yet recruiting

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

• Registration Number: NCT06701929
• Lead Sponsor: Jewish General Hospital

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-29
• Study Start: 2025-03-18
• Primary Completion: 2025-06-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obstetric Quality of Recovery (ObsQoR-11)	3 months	Obstetric 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 Outcome Measures

Name	Time	Method
Nausea & Vomitting	24 hours	The presence of nausea vomiting or retching during or within 24 hours of surgery
Numeric Rating Scale (NRS) Pain Score 2 hours after surgery	2 hours after surgery	Rating of pain, on a scale where 0 is no pain, and 10 is the worst pain imaginable.