The impact of intraoperative methadone on postoperative pain management and opioid consumption in spine surgery patients
Dr. Basma Mohamed
Email
BMohamed@anest.ufl.edu
Phone
(952) 465-6581
Faculty Department/Division
Anesthesiology
This project is primarily:
Clinical
Research Project Description:
Primary aim: To determine whether patients who received a single dose of methadone intraoperatively have decreased postoperative opioids consumption, improved pain scores and functional outcomes, hospital/ICU length of stays, as well as reduced post-operative complications.
Secondary aims: 1) To measure the utilization of methadone and multimodal analgesia after the intervention was implemented. 2) To examine the relationship of various combinations of multimodals used perioperatively and outcomes (postoperative opioids consumption, pain scores, functional outcomes, length of stay, and postoperative complications).
Null Hypothesis:
1) In patients who undergo complex spine surgery, there is no difference in opioid consumption, pain scores and functional related outcome in the group who received a single dose of methadone perioperatively and traditional group who did not.
2) There is no change in the utilization of methadone and multimodal analgesia pattern after the intervention was implemented.
Methods: Inclusion:
All adult patients age >=18 who underwent cervical, thoracic, and lumbar spine surgeries involving fusion and instrumentation at UFHealth between 12/1/2012-and 3/31/2022. The comparison made will be between the pre-intervention group prior and post-intervention group after Dec 1,2017.
Exclusion:
All patients age < 18, emergency spine, trauma spine, simple laminectomy or disectomy without fusion or instrumentation, acute liver failure or cirrhosis, end-stage renal disease or dialysis, incomplete data or lack of electronic medical records
Data collection:
The i2b2, NIH sponsored Query and Analysis Tool, will be used to query the cohort of patients age >=18 years old undergoing cervical, thoracic, and lumbar spine surgeries involving fusion and instrumentation at UFHealth from 5 years pre-implementation of the Spine Pathway (Dec 2012-2017) and post-implementation to current (Dec 2017- March 2022) using CPT code.
Students Role:
Manual chart review helo with the understanding of study design. Data management, data collection, and preliminary statistical analysis.
Does this project have an international component or travel?
No
Impact of Enhanced Recovery After Surgery and perioperative optimization on Perioperative Outcomes in Spine Surgery Patients
Dr. Basma Mohamed
Email
BMohamed@anest.ufl.edu
Phone
(952) 465-6581
Faculty Department/Division
Anesthesiology
This project is primarily:
Clinical
Research Project Description:
This is a retrospective analysis that aims to evaluate a perioperative optimization and enhanced recovery after surgery clinical pathway for patients who underwent elective spine surgery (Cervical, thoracic, or lumbar spine surgery)
The clinical pathway was implemented using the concepts of perioperative surgical home and enhanced recovery after surgery. The clinical pathways aimed to standardize patient care and minimize the rate of postoperative complications. As a result, we hypothesize that implementation of this clinical pathway resulted in
- Decrease in the length of hospital stay
- Decrease in the incidence of postoperative
complications - Decrease in the length of ICU stay.
- Enhance patient recovery time to home.
Evaluation of the clinical pathway will be compared to a historical cohort before implementation of the clinical pathway.
Primary outcome: - Length of hospital stay.
- Length of ICU stay
Secondary outcome: - Incidence of postoperative complications
- 30-day hospital readmission rate
- Discharge to rehabilitation rate.
- Decrease in hospital cost
Other outcome metrics:
HCAHPS or other patient satisfaction metrics
Pain scores
Morphine milligram equivalent per day
Day of the first ambulation
Day of first BM and voiding
Time to first nutrition
PONV rate
Post-discharge opioids
Discharge disposition
30-day readmission rate
30-day ED visits
30-day reoperation
Cost of each episode of care
Oswestry Disability Index
Neck Disability Index
These outcome measures will be compared to a matched historical cohort before implementing the clinical pathway, which started in December 2018.
Methods:
Study Design: This is a retrospective review
Patient population: The study will include a comparison of different variables from implementing the ERAS project on December 1, 2018, till August 31, 2022, and compare to a historical cohort from July 2015 to November 2018
Inclusion criteria:
- Patients 18 years of age or older
- Patients who underwent elective spine surgery.
Exclusion Criteria: - Patients with traumatic spine surgery
- Emergency spine surgery
- Non-elective/urgent spine surgery
Data Collection:
The i2b2 will query the cohort of patients aged >=18 years old undergoing elective spine surgery using CPT codes between July 2015 and August 31, 2022. Once the cohort and quarryable attributes are identified, IDR service will be utilized to obtain the corresponding patient list. Following IRB approval, we will ask the Anesthesiology department’s M500 group to query billing data to run a report of all adult patients who underwent elective spine surgeries at UFHealth between 12/2018 to 8/31/2022, identified by CPT code.
In addition, patients’ medical records will be accessed to complete the process of data collection. REDCap will be used as a data management application.
Role of the Students:
Records will be manually reviewed in Epic and recorded by the investigators into RedCap and independently verified by the second reviewer for potential discrepancies. Please see the attached data collection spreadsheet for specific variables on RedCap.
Does this project have an international component or travel?
No
Point of care gastric ultrasound in ICU patients before and after initiation of post-pyloric enteral feeds
Dr. Meghan Brennan
Email
mbrennan@anest.ufl.edu
Phone
(352) 872-8017
Faculty Department/Division
Anesthesiology
This project is primarily:
Clinical
Research Project Description:
Background: Aspiration of gastric contents during airway manipulation is a risk when undergoing general anesthesia and associated with significant morbidity and mortality. Preoperative fasting recommendations developed by the American Society of Anesthesiologists may not apply in the critically ill patient population. Currently, no consistent preoperative fasting guidelines exist for critically ill patients receiving post-pyloric enteral feeds. Our study aims to evaluate the use of point of care gastric ultrasound (POCUS) to examine gastric content before and after initiation of post-pyloric enteral feeds in intensive care unit (ICU) patients and potentially clarify how fasting guidelines should be applied to this patient population.
Hypothesis: We hypothesize gastric contents in ICU patients receiving enteral feeds through a post-pyloric feeding tube are identifiable on point of care gastric ultrasound and are similar to patients who have consumed medium to high volume clear liquids preoperatively.
Methods: This is a single center prospective observational cohort study of adult patients admitted to the surgical ICUs receiving post-pyloric enteral feeds. POCGUS was performed prior to initiation of enteral feeds and after feeds had been ongoing at goal rate for at least 6 hours. Ultrasound images will be obtained in both the supine and right lateral decubitus positions to identify the gastric antrum and qualitatively characterize its content.
Role of Medical Student: Medical students must complete IRB training. Once that is completed they will be trained in identification of patients that meet study criteria, enrolling patients in the IRB approved study, use of ultrasound, point of care gastric ultrasound with the aim of being able to independently collect study images before the 10-week program ends. Medical students will also assist in data collection from the EPIC EHR for patients enrolled in the study, data analysis, abstract, and manuscript preparation. IRB approval has been obtained for this study, this study is currently enrolling patients, with the participation of medical students in the 2021 and 2022 MSRP cycles.
Funding: Jerome H. Modell Endowed Professorship, through the department of anesthesiology.
Publications: Point of care gastric ultrasound in ICU patients before and after initiation of post-pyloric enteral feeds. Abstract submission to the International Anesthesia Research Society Conference (IARS) 2022, an update was submitted to the 2023 conference. Manuscript preparation is beginning.
Does this project have an international component or travel?
Potentially
The Impact of Enhanced Recovery After Surgery Clinical Pathway On Perioperative Outcomes in Cystectomy Patients
Dr. Basma Mohamed
Email
BMohamed@anest.ufl.edu
Phone
(952) 465-6581
Faculty Department/Division
Anesthesiology
This project is primarily:
Clinical
Research Project Description:
Background:
Radical cystectomy with urinary diversion and bilateral lymphadenectomy is the surgical treatment for bladder cancer. This major abdominal surgery is one of the complex urology surgeries with morbidity and mortality. It has been reported that the postoperative complication rate can range from 6 to 58%. (1,2) Enhanced recovery after surgery is a clinical pathway that focuses on a bundle of interventions aimed at decreasing perioperative stress. The Enhanced Recovery After Surgery Society (ERAS) published guidelines to guide perioperative clinicians to improve patient outcomes, including decreased length of hospital stay, postoperative complications, and healthcare costs. (3) ERAS protocols involve multimodal multidisciplinary bundled interventions that spans throughout the perioperative continuum of care from the time of surgical decision through the postoperative and post-discharge stage. Different interventions at different phases of care include preoperative medical optimization of comorbidities, prehabilitation, and patient education, in addition to optimizing pain management and advocating for early return of physiological functions such as ambulation, nutrition, and return of bowel movement. (4,5,6) At the University of Florida, the Department of Anesthesiology in collaboration with the Urology department designed an enhanced recovery after surgery clinical pathway that aims to improve perioperative outcomes, minimize complications, and reduce readmission rates. The ERAS protocol for cystectomy started in May 2022 to standardize different perioperative interventions and minimize complications.
Hypothesis:
We hypothesize that implementing the ERAS protocol for the cystectomy patients will cause decreased length of stay, lower complication rate, and a decrease in ICU stay when compared to a historical cohort before implementing the ERAS protocol. There is evidence to support the benefits of implementing ERAS in this vulnerable population through multidisciplinary collaboration among anesthesiology, urology, nursing and additional healthcare professionals in the perioperative clinical locations (including intensive care unit and surgical units.
Methods:
Study design: This is a retrospective chart review of a recently implemented quality improvement project focusing on implementation of ERAS in cystectomy patients
Patient population: This study will include patients who met with the following inclusion criteria who underwent cystectomy between January 2021 and November 2022.
Inclusion criteria:
- Patients 18 years of age and older
- Patients who underwent elective cystectomy either open or robot-assisted
Exclusion criteria: - Emergent or urgent cystectomy for radiation or hemorrhagic cystitis
- Cystectomy for treatment of infection or recurrent urinary tract infection
- Any patients with coexisting infection.
- All patients who underwent cystectomy as part of a combined colorectal or gynecological procedure.
Data collection: Preliminary data collection started as part of the quality improvement project. Continued detailed data collection will continue to answer the research question. REDCap will be used as a data management application. Demographics, preoperative, intraoperative, and postoperative data variables, including surgical related data, will be manually reviewed in EPIC and recorded by the investigators into REDCap. Data will be verified for potential discrepancies. Evaluation of the patients who underwent cystectomy during implementing ERAS will be compared to a historical control before implementation of ERAS.
Primary outcomes:
- Hospital length of stay
- ICU length of stay
Secondary outcomes: - Complication rate
- 30-day readmission rate
- 30-day reoperation rate.
- Rate of non-home discharge
Other outcome measures include time to first ambulation, distance of first ambulation, time to first bowel movement, and time to first meal. In addition, pain scores, opioid consumption, and postoperative nausea and vomiting rate will be collected.
Plan for data analysis: Data will be inspected for missing data, plausible values, and distributional form using summary statistics and visual displays. A data dictionary will document and describe each data element. Summary statistics will be calculated for all data elements to include in the study’s data dictionary.
Statistical approaches to address Primary Aim (To compare the pre- and post- Clinical Pathway/ERAS cohorts.): All baseline characteristics will be compared between groups. The relationship between outcomes and predictor variables (i.e., baseline characteristics and intervention group) will be tested. To compare groups on baseline characteristics and outcomes, variables will be analyzed using independent t-tests (for continuous data), Wilcoxon rank sum tests (for ordinal data), and chi-square tests (for categorical data). The relationship between outcomes and predictor variables (i.e., baseline characteristics and intervention group) will be tested. To examine these relationships, correlational testing, ANOVA, t-tests, Wilcoxon rank sum tests, Kruskal-Wallis tests, and chi-square tests will be used. Bivariate testing will be followed by regression modeling to ascertain the predictors (baseline characteristics and intervention group) which are most associated with outcomes of interest. All testing will be two sided and a level of significance will be set at .05.
Statistical approaches to compare groups on outcomes: To compare groups on baseline characteristics and outcomes, variables will be analyzed using ANOVA (for continuous data), Kruskal Wallis tests (for ordinal data), and chi square tests (for categorical data). The relationship between outcomes and predictor variables (i.e., baseline characteristics and utilization group) will be tested. To examine these relationships, correlational testing, ANOVA, t-tests, Wilcoxon rank sum tests, Kruskal-Wallis tests, and chi-square tests will be used. Bivariate testing will be followed by regression modeling to ascertain the predictors (baseline characteristics and Clinical Pathway/ERAS group) which are most associated with outcomes of interest. All testing will be two sided and a level of significance will be set at .05.
Role of medical student:
The medical student will actively participate in the study design and drafting the IRB proposal. They will also perform a literature search to provide the background for the study. The student will then perform the chart review and data collection and will be mentored in performing the statistical analysis for the study. Upon completion of the study, the student will write up the poster for presentation and contribute to writing the paper for publication.
References:
- Ahmadi H, Daneshmand S. Association between use of ERAS protocols and complications after radical cystectomy. World J Urol. 2022;40(6):1311-1316. doi:10.1007/s00345-022-04023-1
- Wei H, Wang M, Wasilijiang W, et al. Propensity score-matched analysis for ileal conduit and orthotopic neobladder intracorporeally accomplished following laparoscopic radical cystectomy. Asian J Surg. 2022;45(4):987-992. doi:10.1016/j.asjsur.2021.08.022
- Cerantola Y, Valerio M, Persson B, et al. Guidelines for perioperative care after radical cystectomy for bladder cancer: Enhanced Recovery After Surgery (ERAS(®)) society recommendations. Clin Nutr Edinb Scotl. 2013;32(6):879-887. doi:10.1016/j.clnu.2013.09.014
- Oberle AD, West JM, Tobert CM, Conley GL, Nepple KG. Optimizing Nutrition Prior to Radical Cystectomy. Curr Urol Rep. 2018;19(12):99. doi:10.1007/s11934-018-0854-4
- Patel SY, Trona N, Alford B, et al. Preoperative immunonutrition and carbohydrate loading associated with improved bowel function after radical cystectomy. Nutr Clin Pract Off Publ Am Soc Parenter Enter Nutr. 2022;37(1):176-182. doi:10.1002/ncp.10661
- Xu W, Daneshmand S, Bazargani ST, et al. Postoperative Pain Management after Radical Cystectomy: Comparing Traditional versus Enhanced Recovery Protocol Pathway. J Urol. 2015;194(5):1209-1213. doi:10.1016/j.juro.2015.05.083
Does this project have an international component or travel?
No
Creation of an intelligent alert to improve efficacy & patient safety in real time during fluoroscopic guided lumbar transforaminalepidural steroid injection
Name:
Dr. Sanjeev Kumar
Email
sanjeevkumar@ufl.edu
Phone
(248) 935-7058
Faculty Department/Division
Anesthesiology
This project is primarily:
Clinical
Research Project Description:
AI (artificial intelligence) will be used to analyze thousands of stored images from UF Pain Medicine conducted LTFESI (Lumbar Transforaminal Epidural Steroid injections) over the past 5 years by a form of deep learning: convolutional neural network(CNN). It uses different modules and segmentation of images to id variations in needle trajectory, tip location and contrast spread and will appropriately map these characterizations as good, acceptable, or unacceptable. The goal is creation of an intelligent alert, to give feedback in real time during future LTFESI to ensure patient safety and improve efficacy.
The project has been Funded by IHAF grant and the IRB approval has been given. Starting date is 3/1/22. This is a collaboration between UF Anesthesiology and UF Department of Biomedical Engineering with Dr. Ruogu Fang as the main collaborator/Co PIfrom UF BME. A UF Engineering post-doc student will be hired to help with designing the convolutional neural network (CNN). UFCTSI will be providing all the deidentified images from patients electronic medical records.
The Medical student’s role could be to assist the UF Engineering grad in testing and refining the CNN on a sample of images and as the CNN gets better then testing and refining it on more images for potentially making the CNN better and better.
This project can be done from anywhere since it mainly involves working with deidentified images from previous procedures done at UF Health.
Does this project have an international component or travel?
No