Quality of Recovery Scores in Parturients With Obesity

March 31, 2023 updated by: Lawson Health Research Institute

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Parturients with Normal Weight
Parturients undergoing elective caesarean delivery with a BMI <30 (control group)
Parturients with Morbid Obesity
Parturients undergoing elective caesarean delivery with a BMI >40 (Study Group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Obstetric Quality of Recovery Score (ObsQoR-10)
Time Frame: 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
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
Time Frame: 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
Immediately after surgery (in PACU) and every 4 hours up to 24 hours after surgery
Opioid Consumption in the first 24 hours
Time Frame: 24 hours post cesarean delivery
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
Time Frame: up to 1 week post operatively
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
Time Frame: 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
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
Time Frame: 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.
In post-anesthesia care unit (PACU), and every 4 hours up to 24 hours after surgery
Nausea and/or Vomiting that required treatment
Time Frame: 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
Absolute number of treatments required in the 24-hour time frame
Pruritus that required treatment
Time Frame: Absolute number of treatments required in the 24-hour time frame.
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
Time Frame: 24 hours post cesarean delivery
Mother breastfeeding at 24 hours: Yes or No
24 hours post cesarean delivery
Time to fist mobilization
Time Frame: 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
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 Frame: 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
Measured in hours from the time of cesarean delivery, up to 48 hours post operatively
Length of hospital stay
Time Frame: 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.
Measured in hours from the time of cesarean, up to to 1 month post operatively (average 48-72 hours)
Unplanned Readmission Rates
Time Frame: 6 weeks post op
Unplanned Readmission Rates prior to 6-week follow up appointment: Yes or No and reason for readmission
6 weeks post op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Ilana Sebbag, MD, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2021

Primary Completion (Actual)

March 18, 2023

Study Completion (Actual)

March 18, 2023

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (Actual)

August 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11292 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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