Quality of Recovery Scores in Parturients With Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Quality of Recovery Scores in Parturients With Obesity: A Prospective Observational Cohort Study

Conditions
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Quality of Recovery, Post Operative Pain

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parturients with Normal Weight<br>Parturients undergoing elective caesarean delivery with a BMI <30 (control group) | |
| Parturients with Morbid Obesity<br>Parturients undergoing elective caesarean delivery with a BMI >40 (Study Group) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Obstetric Quality of Recovery Score (ObsQoR-10) | 10-item questionnaire applied to subjects 24 hours after spinal anesthesia. Measured in a 0-100 scale where 0=poor recovery and 100=perfect recovery | 24 hours post cesarean delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | This is defined as the between- group difference in the mean pain scores on a 0-10 Numeric Rating Scale, as assessed by one of the investigators immediately after surgery (in the Post-Anaesthesia Care Unit) and every 4 hours up to 24 hours after surgery | Immediately after surgery (in PACU) and every 4 hours up to 24 hours after surgery | 
| Opioid Consumption in the first 24 hours | Between-group difference in the total amount of Oral Morphine Equivalents consumed in the first 24 hours after surgery. | 24 hours post cesarean delivery | 
| Total Inpatient Opioid Consumption | Between-group difference in the total amount of Oral Morphine Equivalents consumed during hospital stay. | up to 1 week post operatively | 
| Time-to-first oral opioid analgesic request | This is defined as the length of time between cesarean delivery and the first time the subject requested additional opioid analgesia | 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 | 
| Respiratory Depression | This is defined as respiratory rate<8 breaths/minute, need for naloxone or need for clinical intervention. | In post-anesthesia care unit (PACU), and every 4 hours up to 24 hours after surgery | 
| Nausea and/or Vomiting that required treatment | Nausea/Vomiting episodes that required pharmacological treatment in the first 24 hours post operatively | Absolute number of treatments required in the 24-hour time frame | 
| Pruritus that required treatment | Pruritus episodes that required pharmacological treatment in the first 24 hours post operatively | Absolute number of treatments required in the 24-hour time frame. | 
| Breastfeeding | Mother breastfeeding at 24 hours: Yes or No | 24 hours post cesarean delivery | 
| Time to fist mobilization | Time to fist mobilization (standing and walking independently): measured in hours | Measured in hours from the time of cesarean delivery until patient first mobilizes post operatively, up to 48 hours post operatively. | 
| Time to first oral intake | Time to first oral intake (non-clear fluids): measured in hours | Measured in hours from the time of cesarean delivery, up to 48 hours post operatively | 
| Length of hospital stay | Length of hospital stay: measured in hours. | Measured in hours from the time of cesarean, up to to 1 month post operatively (average 48-72 hours) | 
| Unplanned Readmission Rates | Unplanned Readmission Rates prior to 6-week follow up appointment: Yes or No and reason for readmission | 6 weeks post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean Section, Parturients, Morbid Obesity