EFFECT OF AN ENHANCED RECOVERY AFTER SURGERY PROGRAM ON OPIOID USE AND PATIENT-REPORTED OUTCOMES

Transcription

1 EFFECT OF AN ENHANCED RECOVERY AFTER SURGERY PROGRAM ON OPIOID USE AND PATIENT-REPORTED OUTCOMES Obstetrics & Gynecology Vol. 132, No. 2, August 2018 KUSMW OBGYN Journal Club Thomas Greaves, MD, PGY4 August 15, 2018

2 AUTHORS & CONTRIBUTORS Larissa A. Meyer, MD, MPH, Javier Lasala, MD, Maria D. Iniesta, MD, PhD, Alpa M. Nick, MD, Mark F. Munsell, MS, Qiuling Shi, PhD, Xin Shelley Wang, MD, Katherine E. Cain, PharmD, Karen H. Lu, MD, and Pedro T. Ramirez, MD University of Texas MD Anderson Cancer Center Departments of Gynecologic Oncology and Reproductive Medicine, Anesthesiology and Perioperative Medicine, Biostatistics, and Symptom Research, and the Division of Pharmacy, Houston, TX Tennessee Oncology, Nashville, TN University of Tennessee Health Sciences Center, Memphis, TN Obstetrics & Gynecology, August 9, 2018, Volume 132, No. 2, Pages

3 OBJECTIVE To compare perioperative outcomes in women undergoing surgery before and after implementation of an ERAS program, with a focus on: intraoperative and postoperative opioid consumption patient-reported symptom burden functional recovery

4 BACKGROUND Surgery = significant component of health care/expenditures 8.4 million discharges/year w/ surgical procedure >$157 billion annually Enhanced recovery after surgery (ERAS) = multidisciplinary, multimodal approach to perioperative care that aims to reduce the effects of surgical stress and to avoid traditional aspects of perioperative care that have documented harm E.g., overprescription of opioids New persistent use after surgery estimated 6%. First ERAS protocol in Prior studies: improvements in traditional metrics, but haven t investigated symptom burden and functional recovery from the patient s perspective.

5 MATERIALS AND METHODS ERAS program: Preoperative Medical optimization of chronic disease Nutritional counseling Allowing oral intake of clear fluids up to 2 hours before induction of anesthesia Carbohydrate loading Avoidance of mechanical bowel preparation Goal directed fluid therapy/euvolemia Intraoperative Goal directed fluid therapy/euvolemia Opioid sparing multimodal analgesia Restrictive use of surgical drains Postoperative Opioid sparing multimodal analgesia Emphasis on early ambulation and feeding

6 MATERIALS AND METHODS Cohort 1 All pts + open elective GYN surgery + Nov. 6, 2014 thru Oct. 26, 2015 Cohort 2 Subset of Cohort 1 who reported outcomes/sx burden* Historical Controls All pts + open elective GYN surgery + 6 mos prior to ERAS (May-Oct. 2014) + gave pt-reported outcomes/sx burden* *minimum: preop baseline pt-reported outcomes assessment in addition to assessments on POD#1,2

7 DEMOGRAPHIC INFO COLLECTED Age BMI Ethnicity Race Tumor type primary/recurrent malignant/benign/uncertain malignant potential Indication for surgery Ovarian/fallopian tube/primary peritoneal cancers Cervix cancer Uterine (nonsarcoma) cancer Uterine (sarcoma) cancer American Society of Anesthesiologists (ASA) classification of physical health Charlson Comorbidity Index (excluding current malignancy) Complication rates (Dindo-Clavien grading system) GI, GU, CNS, hematologic complications within 30 days of surgery (mild or severe)

8 PATIENT-REPORTED SYMPTOM BURDEN & INTERFERENCE Historical Controls/Cohort 2 MD Anderson Symptom Inventory-Ovarian Cancer 27-item validated tool 2 additional questions RE: diarrhea/heartburn rank symptom severity, interference on scale 0-10 Administered by voice/phone or link Preoperatively Daily while hospitalized after surgery Days 3 and 7 post discharge Weekly for 7 weeks postoperatively

9 PAIN DATA Patient-reported Pain: Collected within the MD Anderson Symptom Inventory- Ovarian Cancer PACU pain scores assessed using similar 0-10 scale Medications Data: Collected on day of surgery, POD#1-3

10 DATA ANALYSIS Demographic/Clinical Characteristics Descriptive statistics Categorical variables pre/post-eras Fisher exact test Medians between continuous variables Wilcoxon rank-sum test Pain Medication Data Opioid doses collected for first 4 days of hospitalization Converted to morphine equivalent daily doses Sample Size SD for pain at its worst is 2.5; with ½ SD, min important difference is 1.2, estimated minimum of 67 pts Longitudinal Change of sx burden from pain/fatigue/interference during hospitalization Linear mixed-effects Controlling Confounders Age, performance of cytoreductive surgery, cancer site, EBL, surgical complexity score included Time to return to mild or no sx burden (score <4, 2x) Wilcoxon rank-sum test, Kaplan-Meier curves Compliance to ERAS pathway = adherence to recommendations in the published guidelines Estimated percentage of patients with each of the 20 components with a 95% CI.

11 RESULTS: DEMOGRAPHICS, CLINICAL CHARACTERISTICS, PERIOPERATIVE OUTCOMES Cohort 1 = 533 pts in the ERAS pathway Historical Controls = 74 pts Similarities: Median age (both groups) = 58 yrs (range yrs) no differences in ethnicity, ASA/CCI score, BMI, tumor type, indication for surgery, hx of prior chemo/radiation, hx of chronic opioid use Differences: Racial: ERAS had more black/asian women, fewer white women

12 RESULTS: DEMOGRAPHICS, CLINICAL CHARACTERISTICS, PERIOPERATIVE OUTCOMES Cohort 2 = 226 surveyed pts in the ERAS pathway Historical Controls = 67 pts Similarities: No differences in ethnicity, ASA/CCI score, tumor type, indication for surgery, hx of prior chemo/radiation, hx of chronic opioid use Differences: Racial: ERAS had more black women Fewer intraop complications in ERAS group (3.1% vs. 10.5%) No difference in type (GI/GU/CNS/heme) Lower EBL in ERAS group (250 vs. 350)

13 RESULTS: DEMOGRAPHICS, CLINICAL CHARACTERISTICS, PERIOPERATIVE OUTCOMES

14 RESULTS: DEMOGRAPHICS, CLINICAL CHARACTERISTICS, PERIOPERATIVE OUTCOMES Operating Time (median) All: 219 minutes Historical Controls: 236 minutes ERAS: 216 minutes groups Length of Stay (median) Historical Controls: 4 days ERAS: 3 days EBL (median) All: 250cc Historical Controls: 400cc ERAS: 250cc Surgical Complexity Scores No differences between groups GI/GU/CNS/Heme Complications within 30 days No differences between groups for all severity types

15 RESULTS

16 RESULTS: OPIOID USE Intraoperative Historical Controls: morphine equivalents ERAS: 62.5 morphine equivalents (39% reduction) Postop Day 0 Historical Controls: 49.3 morphine equivalents PACU pain score: 6 ERAS: 8 morphine equivalents (83.8% reduction) PACU pain score: 4 Postop Day 1 Historical Controls: 50.6 morphine equivalents ERAS: 10 morphine equivalents (80.2% reduction) Postop Day 2 Historical Controls: 26 morphine equivalents ERAS: 7.5 morphine equivalents (71.2% reduction) Postop Day 3 Historical Controls: 15 morphine equivalents ERAS: 7.5 morphine equivalents (50% reduction) HIGHLIGHTS: *72% reduction in median daily morphine equivalent daily dose in ERAS group *pain scores were not significantly higher *86 ERAS pts were opioidfree from POD#1-3 compared to 0 pre-eras pts

17 RESULTS: PATIENT-REPORTED OUTCOMES Fatigue (most highly-ranked sx in hospital after pain) mean score Significantly lower in ERAS group Interference with Walking mean score Significantly lower in ERAS group Total Interference (calculated composite of interference with work, activity, walking, enjoyment of life, mood, and relations with others) mean score Significantly lower in ERAS group

18 RESULTS: PATIENT-REPORTED OUTCOMES Return to No or Mild Fatigue Significantly shorter in ERAS group Return to No or Mild Interference with Walking Significantly shorter in ERAS group Return to No or Mild Total Interference Significantly shorter in ERAS group

19 DISCUSSION Results: ERAS for open GYN surgeries can improve pt-reported outcomes and significantly decrease the rate of intraoperative and postoperative opioid consumption w/o compromising pain control. Study Type Limitations to Retrospective Case-Control Randomized Control Trial not feasible extensive culture and practice shifts required surgery, anesthesiology, nursing, dietetics, pharmacy all involved Prior Studies vs. This Study: increasing compliance with ERAS protocol elements associated with reduced length of stay and other postop complications High level of compliance in this study, reproduced these findings ERAS can decrease length of stay, complications, cost Future Studies 25% reduction in length of stay, no increase in complication or readmission rates reproduced Patient perspective taken into consideration with this study, also used a validated tool Expand to include pts undergoing minimally invasive surgery Extrapolate to include assessment of 5 year survival (ERAS in colorectal surgery has noted improved survival)

20 DISCUSSION Enhancement in recovery (improved sx burden and functional recovery) with ERAS possibly linked to decrease in opioid use and their typical effects on pt s symptoms Reduction in opioid intake and no increase in pain scores Multimodal analgesia reasonable alternative to traditional analgesia Surgeon General: opioid epidemic a major public health concern Center for Medical Technology Policy: calls for an order-ofmagnitude change in adoption of ERAS to reduce preventable complications and deaths for future surgical patients ERAS is safe, effective, and well-received by patients, comes with improved physical and affective aspects of recovery and a reduction in opioid use. The future of American perioperative care?

21 THANK YOU!