Clinical trial NCT06701929: The Impact of Fasting Duration on Quality of Recovery After Cesarean Section
Official title: How Fasting Duration Before Cesarean Section Affects the Quality of Recovery Score (ObsQoR-11)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Quality Improvement
Quality of Recovery From Anaesthesia
Cesarean Section
Fasting ( 6H for Solid ; 2H for Clear Fluid )
Keywords: Quality of Recovery
cesarean section
fasting duration
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to the Jewish General Hospital for elective cesarean section under spinal anesthesia will be considered for inclusion.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Obstetric Quality of Recovery (ObsQoR-11)
timeFrame: 3 months
Secondary outcomes:
measure: Nausea & Vomitting
timeFrame: 24 hours
measure: Numeric Rating Scale (NRS) Pain Score 2 hours after surgery
timeFrame: 2 hours after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.