Quality of Recovery Scores in Parturients With Obesity

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04988893
• Other study ID #: 11292
• Status: Completed
• Start date: August 9, 2021
• Est. completion date: March 18, 2023

Study information

• Verified date: March 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 18, 2023
• Est. primary completion date: March 18, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Pain, Postoperative
• Post Operative Pain
• Quality of Recovery

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (15)

Bui AH, Feldman DL, Brodman ML, Shamamian P, Kaleya RN, Rosenblatt MA, D'Angelo D, Somerville D, Mudiraj S, Kischak P, Leitman IM. Provider preferences for postoperative analgesia in obese and non-obese patients undergoing ambulatory surgery. J Pharm Policy Pract. 2018 May 17;11:9. doi: 10.1186/s40545-018-0138-x. eCollection 2018. — View Citation

Ciechanowicz S, Howle R, Heppolette C, Nakhjavani B, Carvalho B, Sultan P. Evaluation of the Obstetric Quality-of-Recovery score (ObsQoR-11) following non-elective caesarean delivery. Int J Obstet Anesth. 2019 Aug;39:51-59. doi: 10.1016/j.ijoa.2019.01.010. Epub 2019 Feb 2. — View Citation

Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31. — View Citation

Elsamadicy AA, Camara-Quintana J, Kundishora AJ, Lee M, Freedman IG, Long A, Qureshi T, Laurans M, Tomak P, Karikari IO. Reduced Impact of Obesity on Short-Term Surgical Outcomes, Patient-Reported Pain Scores, and 30-Day Readmission Rates After Complex Spinal Fusion (>/=7 Levels) for Adult Deformity Correction. World Neurosurg. 2019 Jul;127:e108-e113. doi: 10.1016/j.wneu.2019.02.165. Epub 2019 Mar 12. — View Citation

Galic S, Oakhill JS, Steinberg GR. Adipose tissue as an endocrine organ. Mol Cell Endocrinol. 2010 Mar 25;316(2):129-39. doi: 10.1016/j.mce.2009.08.018. Epub 2009 Aug 31. — View Citation

Gletsu N, Lin E, Zhu JL, Khaitan L, Ramshaw BJ, Farmer PK, Ziegler TR, Papanicolaou DA, Smith CD. Increased plasma interleukin 6 concentrations and exaggerated adipose tissue interleukin 6 content in severely obese patients after operative trauma. Surgery. 2006 Jul;140(1):50-7. doi: 10.1016/j.surg.2006.01.018. — View Citation

Kim MG, Yook JH, Kim KC, Kim TH, Kim HS, Kim BS, Kim BS. Influence of obesity on early surgical outcomes of laparoscopic-assisted gastrectomy in gastric cancer. Surg Laparosc Endosc Percutan Tech. 2011 Jun;21(3):151-4. doi: 10.1097/SLE.0b013e318219a57d. — View Citation

Kruger MT, Naseri Y, Hohenhaus M, Hubbe U, Scholz C, Klingler JH. Impact of morbid obesity (BMI > 40 kg/m2) on complication rate and outcome following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). Clin Neurol Neurosurg. 2019 Mar;178:82-85. doi: 10.1016/j.clineuro.2019.02.004. Epub 2019 Feb 4. — View Citation

Mei W, Seeling M, Franck M, Radtke F, Brantner B, Wernecke KD, Spies C. Independent risk factors for postoperative pain in need of intervention early after awakening from general anaesthesia. Eur J Pain. 2010 Feb;14(2):149.e1-7. doi: 10.1016/j.ejpain.2009.03.009. Epub 2009 May 6. — View Citation

Musaad S, Haynes EN. Biomarkers of obesity and subsequent cardiovascular events. Epidemiol Rev. 2007;29:98-114. doi: 10.1093/epirev/mxm005. Epub 2007 May 10. — View Citation

Sharawi N, Klima L, Shah R, Blake L, Carvalho B, Sultan P. Evaluation of patient-reported outcome measures of functional recovery following caesarean section: a systematic review using the consensus-based standards for the selection of health measurement instruments (COSMIN) checklist. Anaesthesia. 2019 Nov;74(11):1439-1455. doi: 10.1111/anae.14807. Epub 2019 Aug 20. — View Citation

Sorimachi Y, Neva MH, Vihtonen K, Kyrola K, Iizuka H, Takagishi K, Hakkinen A. Effect of Obesity and Being Overweight on Disability and Pain After Lumbar Fusion: An Analysis of 805 Patients. Spine (Phila Pa 1976). 2016 May;41(9):772-7. doi: 10.1097/BRS.0000000000001356. — View Citation

Sultan P, Carvalho B. Postpartum recovery: what does it take to get back to a baseline? Curr Opin Obstet Gynecol. 2021 Apr 1;33(2):86-93. doi: 10.1097/GCO.0000000000000684. — View Citation

Sultan P, Kormendy F, Nishimura S, Carvalho B, Guo N, Papageorgiou C. Comparison of spontaneous versus operative vaginal delivery using Obstetric Quality of Recovery-10 (ObsQoR-10): An observational cohort study. J Clin Anesth. 2020 Aug;63:109781. doi: 10.1016/j.jclinane.2020.109781. Epub 2020 Mar 20. — View Citation

Vincent HK, Taylor AG. Biomarkers and potential mechanisms of obesity-induced oxidant stress in humans. Int J Obes (Lond). 2006 Mar;30(3):400-18. doi: 10.1038/sj.ijo.0803177. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	Breastfeeding	Mother breastfeeding at 24 hours: Yes or No	24 hours post cesarean delivery
Secondary	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.
Secondary	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
Secondary	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)
Secondary	Unplanned Readmission Rates	Unplanned Readmission Rates prior to 6-week follow up appointment: Yes or No and reason for readmission	6 weeks post op

External Links

•   17. Sealed Envelope Ltd. 2012. Power calculator for continuous outcome superiority trial
•   WHO. Fact Sheet: Obesity and overweight. 2006.