Clinical trial NCT04988893: Quality of Recovery Scores in Parturients With Obesity
Official title: Quality of Recovery Scores in Parturients With Obesity: A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Recovery
Post Operative Pain
Keywords: Cesarean Section
Parturients
Morbid Obesity
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women meeting inclusion and exclusion criteria who are scheduled to have their Caesarean Section at Victoria Hospital, London Health Sciences Centre will be consented for participation in the study. Patients will be recruited from obstetrical and preadmission clinics at LHSC Victoria Hospital, as well as at admission for Caesarean Section to the Obstetrical Care Unit. Patients will be recruited only when inclusion criteria are fulfilled, in the absence of exclusion criteria, and after informed consent has been obtained.

Brief summary: The prevalence of obesity has increased dramatically recently. Obesity is a pro-inflammatory state which leads to chronic low grade inflammation having different systemic effects. This may make obesity an independent risk factor for severe acute postoperative pain. No prospective studies have been conducted to specifically evaluate the quality of recovery after caesarean delivery for women with morbid obesity when compared to non-obese parturients. In addition, while there is biological plausibility to infer worse pain scores in parturients with obesity, the magnitude of this difference is unknown and information guiding adjustments in pain management are lacking.

Detailed description: The prevalence of obesity has increased dramatically over the recent past in both developed and developing countries.

Obesity is a pro-inflammatory state which leads to chronic low grade inflammation. It has been well studied that this very inflammation and oxidative stress is responsible for cardiovascular pathologies seen in these patients. As a result, the post-operative period is characterized by a phase of prolonged systemic inflammatory response, which makes obesity an independent risk factor for severe acute pain. As a matter of fact, an extreme rise in IL-6 in patients with obesity has been demonstrated post-operatively.

In addition, adipose tissue acts as an endocrine organ by releasing a number of other pro-inflammatory proteins. Cytokines are known to promote various metabolic, hemodynamic and immunologic changes post-surgery, and in the setting of exaggerated inflammatory response can lead to increased pain and hemodynamic instability.

Very few studies have evaluated the recovery experience of patients with obesity in the acute postoperative period. Patients with obesity undergoing general abdominal surgery have been shown to have worse surgical outcomes, increased complication rates, and increased analgesic requirements.7 However, in spine surgery, there have been conflicting evidence supporting a difference in pain scores in patients with obesity. Despite there being no clear guidelines on post-operative pain control between these two groups, providers reported prescribing less opioid analgesics post-operatively to patients with obesity when compared to patients not suffering from this condition.

The Obstetric Quality of Recovery Score (ObsQoR) was initially developed and validated as a measure of patient reported outcome after caesarean delivery. It started as an 11-item questionnaire (ObsQoR-11), which was further simplified to 10-items (ObsQoR-10) following patient feedback where moderate and severe pain questions were combined into a single item. This tool measures pain, nausea or vomiting, dizziness, shivering, comfort, mobility, ability to hold and feed the baby, personal hygiene maintenance, and feeling in control, to provide a global inpatient postpartum quality of recovery score out of 100. A systematic review assessing measurement properties of available patient-reported outcome measures using COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) methodology, recommended ObsQoR as the best available instrument to measure functional recovery following caesarean delivery.

No prospective studies have been conducted to specifically evaluate the quality of recovery after caesarean delivery for women with morbid obesity when compared to non-obese parturients. In addition, while there is biological plausibility to infer worse pain scores in parturients with obesity, the magnitude of this difference is unknown and information guiding adjustments in pain management are lacking.

The investigators hypothesize that parturients with Class 3 obesity experience impaired quality of recovery scores after elective cesarean delivery as measured by the ObsQoR-10 when compared to non-obese parturients.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Term pregnancy (\> 37 weeks gestational age)
* Elective caesarean delivery
* BMI \>40 (Study Group) or BMI \<30 (Control Group)
* ASA\<=3

Exclusion Criteria:

* Chronic pain
* History of opioid use during pregnancy.
* History of substance abuse disorder during pregnancy.
* Contraindication to neuraxial opioids, acetaminophen and/or NSAIDs
* Language barrier
* Allergy to Opioids or NSAIDS
* Intra-operative conversion to general anesthesia
* Maternal Admission to ICU.
* Neonatal admission to NICU.

Primary outcomes:
measure: Difference in Obstetric Quality of Recovery Score (ObsQoR-10)
timeFrame: 24 hours post cesarean delivery
Secondary outcomes:
measure: Difference in Average Numeric Rating Score (0-10 , where 0=no pain and 10= maximum pain) at specific time points in the first 24 hours
timeFrame: Immediately after surgery (in PACU) and every 4 hours up to 24 hours after surgery
measure: Opioid Consumption in the first 24 hours
timeFrame: 24 hours post cesarean delivery
measure: Total Inpatient Opioid Consumption
timeFrame: up to 1 week post operatively
measure: Time-to-first oral opioid analgesic request
timeFrame: Measured in hours from the time of cesarean delivery until patient request for prescribed oral opioid analgesia, up to 24 hours from the spinal anesthetic
measure: Respiratory Depression
timeFrame: In post-anesthesia care unit (PACU), and every 4 hours up to 24 hours after surgery
measure: Nausea and/or Vomiting that required treatment
timeFrame: Absolute number of treatments required in the 24-hour time frame
measure: Pruritus that required treatment
timeFrame: Absolute number of treatments required in the 24-hour time frame.
measure: Breastfeeding
timeFrame: 24 hours post cesarean delivery
measure: Time to fist mobilization
timeFrame: Measured in hours from the time of cesarean delivery until patient first mobilizes post operatively, up to 48 hours post operatively.
measure: Time to first oral intake
timeFrame: Measured in hours from the time of cesarean delivery, up to 48 hours post operatively
measure: Length of hospital stay
timeFrame: Measured in hours from the time of cesarean, up to to 1 month post operatively (average 48-72 hours)
measure: Unplanned Readmission Rates
timeFrame: 6 weeks post op
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University
name: Ilana Sebbag, MD
role: PRINCIPAL_INVESTIGATOR
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