Quality of RecoveryNCT04988893
Quality of Recovery Scores in Parturients With Obesity
An observational study of Quality of Recovery and Post Operative Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Quality of Recovery, Post Operative Pain
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 9 Aug 2021to 18 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18 years
- Term pregnancy (> 37 weeks gestational age)
- Elective caesarean delivery
- BMI >40 (Study Group) or BMI <30 (Control Group)
- ASA<=3
Who cannot join
- 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
Show all 9Show fewer
- Intra-operative conversion to general anesthesia
- Maternal Admission to ICU.
- Neonatal admission to NICU.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Quality of Recovery, Post Operative Pain
- Keywords
- Cesarean Section, Parturients, Morbid Obesity
- Medical subject headings
- Pain, Postoperative, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours post cesarean delivery
Secondary outcomes (12)
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
Measured: 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.
Measured: 24 hours post cesarean delivery
Total Inpatient Opioid Consumption
Between-group difference in the total amount of Oral Morphine Equivalents consumed during hospital stay.
Measured: 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: 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.
Measured: 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
Measured: 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
Measured: Absolute number of treatments required in the 24-hour time frame.
Breastfeeding
Mother breastfeeding at 24 hours: Yes or No
Measured: 24 hours post cesarean delivery
Time to fist mobilization
Time to fist mobilization (standing and walking independently): measured in hours
Measured: 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: 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: 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
Measured: 6 weeks post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start9 Aug 2021
- Primary completion18 Mar 2023
- Study completion18 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Quality of RecoveryStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ilana Sebbag, MD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988893
- Sponsor's protocol ID
- 11292
- Status last verified
- Mar 2023
- First submitted
- 13 Jul 2021
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16302012Musaad 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.
PubMed 17494057Mei 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.
PubMed 19423369Gletsu 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.
PubMed 16857442Galic 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.
PubMed 19723556Kim 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.
PubMed 21654297Elsamadicy 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.
PubMed 30876992Sorimachi 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.
PubMed 26656059Kruger 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.
PubMed 30739072Bui 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.
PubMed 29796284Ciechanowicz 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.
PubMed 30579408Ciechanowicz 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.
PubMed 30885691Sultan 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.
PubMed 32203873Sharawi 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.
PubMed 31429919Sultan 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.
PubMed 33395109
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Recovery Scores in Parturients With Obesity: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04988893
- Acronym / sponsor ID
- 11292
- Conditions
- Quality of Recovery, Post Operative Pain
- Keywords
- Cesarean Section, Parturients, Morbid Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 18 Mar 2023 (actual)
- Study completion
- 18 Mar 2023 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Age > 18 years
- Term pregnancy (> 37 weeks gestational age)
- Elective caesarean delivery
- BMI >40 (Study Group) or BMI <30 (Control Group)
- ASA<=3
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
12 secondary outcomes
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
Opioid Consumption in the first 24 hours
Time frame: 24 hours post cesarean delivery
Total Inpatient Opioid Consumption
Time frame: 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
Respiratory Depression
Time frame: 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
Pruritus that required treatment
Time frame: Absolute number of treatments required in the 24-hour time frame.
Breastfeeding
Time frame: 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 first oral intake
Time frame: 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)
Unplanned Readmission Rates
Time frame: 6 weeks post op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Background: PubMed 16302012Vincent 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.
- Background: PubMed 17494057Musaad 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.
- Background: PubMed 19423369Mei 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.
- Background: PubMed 16857442Gletsu 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.
- Background: PubMed 19723556Galic 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.
- Background: PubMed 21654297Kim 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.
- Background: PubMed 30876992Elsamadicy 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.
- Background: PubMed 26656059Sorimachi 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.
- Background: PubMed 30739072Kruger 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.
- Background: PubMed 29796284Bui 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.
- Background: PubMed 30579408Ciechanowicz 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.
- Background: PubMed 30885691Ciechanowicz 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.
- WHO. Fact Sheet: Obesity and overweight. 2006.Link provided by the sponsor.
- 17\. Sealed Envelope Ltd. 2012. Power calculator for continuous outcome superiority trialLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilana Sebbag, MD principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Recovery and Post Operative Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Obstetric Quality of Recovery Score (ObsQoR-10) (time frame: 24 hours post cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988893, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.