Quality of Recovery Scores in Parturients With Obesity

Completed

• Conditions: Post Operative Pain; Quality of Recovery

• Registration Number: NCT04988893
• Lead Sponsor: Lawson Health Research Institute

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.

Study Timeline

• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-22
• Study First Posted: 2021-08-04
• Study Start: 2021-08-09
• Status Verified: 2023-03
• Primary Completion: 2023-03-18
• Study Completion: 2023-03-18
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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
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
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
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.
Breastfeeding	24 hours post cesarean delivery	Mother breastfeeding at 24 hours: Yes or No
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.
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
Unplanned Readmission Rates	6 weeks post op	Unplanned Readmission Rates prior to 6-week follow up appointment: Yes or No and reason for readmission

Trial Locations

Locations (1)

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada