Post Operative Pain, Quality of Recovery
Conditions
Keywords
Cesarean Section, Parturients, Morbid Obesity
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.
Interventions
None listed
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Obstetric Quality of Recovery Score (ObsQoR-10) | 24 hours post cesarean delivery | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption in the first 24 hours | 24 hours post cesarean delivery | Between-group difference in the total amount of Oral Morphine Equivalents consumed in the first 24 hours after surgery. |
| Total Inpatient Opioid Consumption | up to 1 week post operatively | Between-group difference in the total amount of Oral Morphine Equivalents consumed during hospital stay. |
| Time-to-first oral opioid analgesic request | 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 | This is defined as the length of time between cesarean delivery and the first time the subject requested additional opioid analgesia |
| Respiratory Depression | In post-anesthesia care unit (PACU), and every 4 hours up to 24 hours after surgery | This is defined as respiratory rate\<8 breaths/minute, need for naloxone or need for clinical intervention. |
| Nausea and/or Vomiting that required treatment | Absolute number of treatments required in the 24-hour time frame | Nausea/Vomiting episodes that required pharmacological treatment in the first 24 hours post operatively |
| 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 | Immediately after surgery (in PACU) and every 4 hours up to 24 hours after surgery | 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 |
| Breastfeeding | 24 hours post cesarean delivery | Mother breastfeeding at 24 hours: Yes or No |
| Time to fist mobilization | Measured in hours from the time of cesarean delivery until patient first mobilizes post operatively, up to 48 hours post operatively. | Time to fist mobilization (standing and walking independently): measured in hours |
| Time to first oral intake | Measured in hours from the time of cesarean delivery, up to 48 hours post operatively | Time to first oral intake (non-clear fluids): measured in hours |
| Length of hospital stay | Measured in hours from the time of cesarean, up to to 1 month post operatively (average 48-72 hours) | Length of hospital stay: measured in hours. |
| Unplanned Readmission Rates | 6 weeks post op | Unplanned Readmission Rates prior to 6-week follow up appointment: Yes or No and reason for readmission |
| Pruritus that required treatment | Absolute number of treatments required in the 24-hour time frame. | Pruritus episodes that required pharmacological treatment in the first 24 hours post operatively |
Countries
Canada
Outcome results
None listed