Rapid Recovery Pathway After Spinal Fusion for Idiopathic Scoliosis
BACKGROUND: Posterior spinal fusion (PSF) for adolescent idiopathic scoliosis (AIS) is associated with significant pain and prolonged hospitalization. There is evidence that early mobilization and multimodal analgesia can accelerate functional recovery and reduced length of stay (LOS). Using these principles, we implemented a quality improvement initiative to enable earlier functional recovery in our AIS–PSF population.
METHODS: We designed and implemented a standardized rapid recovery pathway (RRP) with evidence-based management recommendations for children aged 10 to 21 years undergoing PSF for AIS. Our primary outcome, functional recovery, was assessed using statistical process control charts for LOS and average daily pain scores. Our process measures were medication adherence and order set utilization. The balancing measure was 30-day readmission rate.
RESULTS: We included 322 patients from January 1, 2011 to June 30, 2015 with 134 (42%) serving as historical controls, 104 (32%) representing our transition population, and 84 (26%) serving as our RRP population. Baseline average LOS was 5.7 days and decreased to 4 days after RRP implementation. Average daily pain scores remained stable with improvement on postoperative day 0 (3.8 vs 4.9 days) and 1 (3.8 vs 5 days) after RRP implementation. In the second quarter of 2015, gabapentin (91%) and ketorolac (95%) use became routine and order set utilization was 100%. Readmission rates did not increase as a result of this pathway.
CONCLUSIONS: Implementation of a standardized RRP with multimodal pain management and early mobilization strategies resulted in reduced LOS without an increase in reported pain scores or readmissions.
- AIS —
- adolescent idiopathic scoliosis
- ED —
- emergency department
- IVPCA —
- intravenous patient controlled analgesia
- LOS —
- length of stay
- POD —
- postoperative day
- PDSA —
- PSF —
- posterior spinal fusion
- PT —
- physical therapy
- QI —
- quality improvement
- RRP —
- rapid recovery pathway
- SPC —
- statistical process control
Adolescent idiopathic scoliosis (AIS) is the most common pediatric spinal disorder in North America with an average of 5000 AIS spine fusions performed annually from 2001 to 2011.1 Surgical correction of AIS presents a number of perioperative challenges including effective pain control, management of opioid related side effects, and delay in mobilization. This can result in significant patient morbidity with the potential for prolonged hospitalization and delayed functional recovery at home.2 Recent data suggests that the average length of stay (LOS) for a patient undergoing posterior spinal fusion (PSF) for idiopathic scoliosis is 5 to 6 days.3–5 There is evidence that nonopioid analgesics can improve pain management in adolescents undergoing PSF.6–8 Additionally, early mobilization strategies and dietary liberalization with early discontinuation of intravenous opioids can reduce LOS and costs without increasing early or late complications in adolescents undergoing PSF.9 However, little is known about the quality of recovery when using an accelerated recovery pathway.
Within our institution, postoperative management was variable. Some surgeons adopted early mobilization strategies with multimodal analgesics, including ketorolac and gabapentin, whereas others used conventional recovery strategies with 24 hours of bed rest and an opioid-based analgesic platform. In an effort to reduce this variability, we convened a multidisciplinary quality improvement (QI) team to redesign, standardize, and implement a recovery pathway for healthy adolescents undergoing multilevel PSF for idiopathic scoliosis. The goals were to incorporate early mobilization strategies to facilitate earlier functional recovery while maintaining effective analgesia with an evidence-based multimodal analgesic protocol.
Before initiation of this project, multiple “standards” of care existed for postoperative management after PSF. We felt an obligation to formalize a management protocol for this population and design a method for monitoring compliance and effectiveness. As this protocol represents QI work, it is not considered human subjects research, and we received exemption from our Institutional Review Board.
Setting and Study Groups
This QI project was conducted at a major tertiary care pediatric hospital that performs 60 to 90 spinal fusions for idiopathic scoliosis annually. All patients with scoliosis who underwent PSF were identified using a combination of diagnosis and procedure codes (Current Procedural Terminology codes 22802, 22804, 22843, 22844 and International Classification of Diseases, Ninth Revision code 737.30). Patients with neuromuscular scoliosis, a congenital/genetic/developmental delay diagnosis, anterior spinal fusion, or intraoperative complications, including respiratory depression, hemorrhage, coagulopathy, or loss of motor signals, were excluded. Because our postoperative standard of care was surgical floor admission, we excluded patients who were admitted to the ICU or a nonsurgical recovery floor for >24 hours because initial recovery may have been delayed due to surgical complications or inconsistent care provided on nonsurgical floors. Finally, the study group was divided into three time periods: conventional management (January 1, 2011 to December 31, 2012), transitional management (January 1, 2013 to June 30, 2014) and standardized pathway implementation (July 1 2014 to June 30, 2015).
Historically, postoperative care for PSF patients consisted of limited movement for the first 24 hours, initiation of physical therapy (PT) on postoperative day (POD) 2, nil per os for the first 24 hours with diet advancement beginning on POD 2, and eventual discharge after PT clearance, first bowel movement, and surgical drain removal. Analgesic management consisted of an intraoperative dose of methadone (0.1–0.2 mg/kg) and postoperative morphine or hydromorphone intravenous patient controlled analgesia (IVPCA) for 3 to 4 days with eventual transition to oral oxycodone and acetaminophen. Oral diazepam was used throughout recovery for muscle spasm.
Conventional pain management after PSF was dictated by the orthopedic surgeons and facilitated by the acute pain service. Incorporation of nonopioid agents other than benzodiazepines or acetaminophen was uncommon and interdisciplinary management discussions were rare. Starting in 2013, members of the orthopedic and pain services began to collaborate to reassess our standard management. Informal plan-do-study-act (PDSA) cycles with medication (ketorolac and gabapentin) pilots and physical activity acceleration were conducted. These efforts aimed to improve the quality of recovery by reducing opioid dependence for pain management and enabling earlier rehabilitation. All patients were monitored by a small group of physicians, nurse practitioners, nurses, and physical therapists. Patients were noted to be more comfortable with a trend toward earlier discharge readiness.
A number of challenges to widespread implementation of our management strategies existed. These included patient identification and preoperative medication ordering in the outpatient clinic, pain service implementation of analgesic protocols, ensuring consistent PT availability for early rehabilitation efforts, and spreading awareness of these strategies to a number of clinical departments.
Rapid Recovery Pathway
Building on transitional period efforts, a larger multidisciplinary team was assembled including anesthesiologists, orthopedic surgeons, inpatient and outpatient orthopedic nurse practitioners, physicians and a nurse practitioner from the acute pain service, a pharmacist, a physical therapist, and surgical recovery unit nurses. We received institutional support in the form of a clinical quality improvement advisor and data analyst who facilitated the QI project. The overall aim was to develop, implement, and demonstrate efficacy and safety of the pathway. Using the PDSA cycles and lessons from the transition period, we developed a standardized clinical care pathway outlining nursing, PT, and pain management recovery goals for each postoperative day. This pathway was published as a Web-based algorithm (Fig 1; http://www.chop.edu/clinical-pathway/spinal-fusion-post-op-adolescent-idiopathic-scoliosis-ais-clinical-pathway) on our institutional Web site to codify the recovery process and provide a clinical education resource. The full details of the rapid recovery pathway (RRP) are outlined in Supplemental Fig 5. In addition, we built computer-based order entry order sets within our electronic health record (EPIC) for all phases of the patient’s care: the outpatient orthopedic surgery clinic visit, the inpatient postsurgical encounter, and the acute pain service. These order sets simplify compliance among front-line clinicians by embedding the pathway recommendations into their daily workflow.
Pathway Implementation and Early Challenges
Members of our QI team organized the pathway roll out using divisional educational sessions for messaging. An early challenge was the inconsistent application of PT and pain service goals on the weekends when staffing is limited. Patients were not receiving PT consistently on POD 1, and IVPCA’s were maintained through POD 3. Based on these findings, QI participants from PT and pain service went back to their divisions and reinforced the need to maintain consistent application of pathway goals with respect to scheduled PT sessions and transitioning off the IVPCA, if appropriate, on the weekends. Additionally, some surgeons hesitated using ketorolac in their patients. We reviewed these concerns and discussed the evidence supporting the efficacy and safety of ketorolac. Ultimately, all surgeons performing spinal fusions agreed to use ketorolac in AIS patients while use of ketorolac in patients with neuromuscular scoliosis would be reviewed on a case-by-case basis.
Process, Outcome, and Balancing Measures
To monitor the QI initiative, process, outcome, and balancing measures were displayed using the data visualization tool QlikView (Radnor, PA). Development of this tracking tool involved defining the patient population of interest, tolerating some noise in the data, and picking extractable and measurable metrics.
Our initial process measures were use of multimodal agents (gabapentin and ketorolac) and discontinuation of IVPCA before POD 3. Once the order set was completed and activated in January 2015, use of the order set was included as a process measure to track compliance.
Our primary outcome was functional recovery or discharge readiness. We tracked this outcome using the surrogate measures average LOS and pain scores on POD 0 (end of surgery to 6 am) and POD 1, 2, and 3 (6 am to 6 am). Both LOS and pain scores were thought to be appropriate markers of functional recovery because patients cannot be discharged until they are cleared by PT and their pain is adequately controlled. As a balancing measure, we collected information regarding 30-day emergency department (ED) visits and/or readmission.
We tracked our outcomes using statistical process control (SPC) charts for mean LOS and average daily pain scores on POD 0 to 3. Because of variability in the number of patients each month, we grouped patients in quarterly blocks to have sufficient patient numbers to use X-bar and S-chart methodology. X-bar charts express the averages with control limits for each subgroup over time whereas S-charts characterize the spread between measurements within each subgroup.10
Charts were created with SPC for Excel (BPI Consulting, LLC, Cypress, TX), and the conventional management time period (January 1, 2011 to December 31, 2012) was used to generate an historical average as well as trial control limits for LOS and daily pain scores. Control limits were set at 3 SDs from the mean. Although 20 to 30 subgroups are needed to establish process stability, we elected to present the historical control in 8 quarterly subgroups. Analysis using 24 monthly subgroups was inappropriate due to variability in monthly surgical volume and subgroup data before 2011 could not be extracted because we were using a different electronic medical record. We feel the use of the conventional management population for our trial limits is justified because it represents a large patient population over 2 years with a stable recovery process.
For simplicity, presence of a single point outside control limits was used to determine if the observed changes were due to our interventions (special cause variation) or random variation (common cause variation) with an acknowledgment that a number of rules could be considered to signify special cause variation.10 Because we only have 1 year of data after pathway implementation, we did not revise our charts in the event of an indication of special cause variation. S-charts generated for LOS and pain scores demonstrated common cause variation (charts not presented), thus validating the X-bar chart.
A total of 328 adolescent PSF patients managed by 6 different surgeons from January 1, 2011 through June 30, 2015 were identified. Of those patients, 322 had complete pain scores recorded from POD 0 through POD 2 and were included for analysis. Patient characteristics were similar among the historical, transitional, and pathway periods (Table 1).
As multimodal medication administration is a hallmark of this pathway, gabapentin and ketorolac administration was selected as an early process measure. Figure 2 highlights the evolving nature of our QI project. Beginning in the second quarter of 2013, ketorolac was initiated on POD 1 for the first time. Gabapentin was introduced in the first quarter of 2014, which coincided with a consistent pattern of IVPCA discontinuation on POD 2. Overall adherence to the multimodal analgesic regimen continued to improve after full pathway implementation in July 2014 with 89% of patients receiving ketorolac on POD 1, 100% of patients receiving gabapentin on the night of surgery, and 86% of patients off of their IVPCA by POD 3 in the second quarter of 2015. Additionally, adherence to order set use, which began mid–first quarter of 2015 was 100% by the second quarter of 2015.
SPC charts for mean LOS is presented in Fig 3. There is strong evidence of a special cause reduction in LOS with 4 consecutive data points outside the lower control limit with RRP implementation. Average LOS during the conventional management period from January 1, 2011 to December 31, 2012 was 5.7 days and fell to 4 days after institution of the RRP from July 1, 2014 to June 30, 2015.
SPC charts for pain scores are presented in Fig 4 and indicate a special cause pain reduction after RRP implementation. This is seen on POD 0 (average pain score 3.8 vs 4.9), where there was 1 point outside the lower control limit in the third quarter of 2014, and on POD 1 (average pain score 3.8 vs 5), with 2 points below the lower control limit. Pain scores for POD 2 and POD 3 (not shown) revealed common cause variation and average pain scores were similar between the conventional management and RRP time periods.
The incidence of 30-day readmissions or ED visits after discharge was 2.9% (7/238 patients) for the first quarter of 2011 through the second quarter of 2014. From the third quarter of 2014 through the second quarter of 2015, 3.6% (3/84) of patients were seen in the ED and/or admitted for postoperative issues. One patient, readmitted for nausea and vomiting related to oxycodone, improved with rehydration and a change to enteral hydromorphone. The other 2 patients were evaluated for possible wound infections.
We present our experience using an early mobilization RRP with multimodal analgesic strategies to improve the quality of recovery for pediatric patients undergoing PSF for AIS. Our clinical pathway reduced time to functional recovery, as reflected by shorter LOS, while maintaining effective analgesia and potentially improving pain scores on POD 0 and 1 without an increase in the rate of readmission.
The pain after PSF is often severe and difficult to control without significant side effects. Traditional management using bed rest and slow return to activity after surgery is likely unnecessary and may actually contribute to patient morbidity. In adults, early mobilization strategies with multimodal analgesia techniques are routinely used after major orthopedic surgery from total hip replacements to spine fusion.11,12
Our traditional approach included the use of intraoperative methadone, which acts as a μ-opioid agonist and N-methyl-D-aspartate (NMDA) receptor antagonist and has been shown to be helpful in reducing opioid consumption after spinal fusion in adults.13 However, with the exception of oral acetaminophen and oral diazepam for muscle spasms, postoperative analgesia was almost entirely dependent on opioids. Patients were often somnolent and/or nauseated, and we sought to improve the quality of the recovery by focusing on early mobilization and reducing reliance on intravenous opioids for pain control.
There is growing evidence to support the use of several nonopioid pharmacological analgesic classes including gabapentinoids, acetaminophen (paracetamol), and nonsteroidal antiinflammatory drugs14 after major orthopedic surgery. Gabapentin has been studied for pediatric PSF with conflicting results. One study reported improved early pain scores and reduced opioid consumption in the first 48 hours after surgery with preoperative and postoperative gabapentin administration,7 whereas another study found no difference in pain scores after a single preoperative dose.15 Intravenous acetaminophen has been proposed as a useful adjuvant in pain management after major orthopedic surgery8 and, within pediatric PSF patients, intravenous acetaminophen has been shown to improve early pain scores but has no effect on opioid consumption.16 Ketorolac has been shown to improve analgesia and reduce opioid consumption while reducing both opioid-related gastrointestinal side effects and LOS in general pediatric orthopedic populations17,18 and pediatric spinal fusion populations.6 Although some have cautioned against the use of ketorolac in major orthopedic surgery because of concerns about platelet dysfunction and impaired bone healing,19,20 there is growing evidence that ketorolac is safe in pediatric orthopedic populations21–23 and spinal fusion populations.24,25
We found that our pairing of a multimodal pain protocol with early rehabilitation was not associated with an increase in self-reported pain scores, and there is early suggestion that the pain improved on POD 0 and 1. We used self-reported pain scores as both an outcome and a balancing measure. With early mobilization, we were concerned that patients would have increased pain, and we preemptively altered our analgesic pathway to optimize pain relief. Anecdotally, all providers felt that the patients appeared more awake and comfortable on POD 0, 1, and 2 compared with traditionally managed patients. Based on our previous experience with this population, it seems unlikely that we would have been able to make this early transition to PT without the successful implementation of our multimodal analgesic regimen.
Strengths and Limitations
Strengths of this QI project include the relatively large sample of 322 patients with an intervention group consisting of 84 patients managed over the course of 1 year. Formal facilitation by QI advisors allowed for multidisciplinary team meetings over 6 months and the creation of a real-time and transparent data visualization tool to monitor patient outcomes. This aided the spread of early mobilization strategies and medication protocols to all surgeons caring for these patients. Future PDSA cycles may involve the introduction of surveys to monitor patient reported quality of recovery in both the inpatient and outpatient setting.
Despite the majority buy-in, the interventions were not entirely standardized among the improvement intervention group because some surgeons initially resisted using ketorolac. We elected to present the results of our interventions as all cases of PSF for AIS rather than focusing on the outcomes of the surgeons involved in early PDSA cycles because this is a more accurate representation of the realities of implementing QI projects in clinical settings where “best practices” remain subject to debate.
Caution must be used in drawing conclusions about the effect of our pathway on postoperative pain. Frontline clinicians were not blinded to treatment strategies, and they may have influenced the patients’ responses. This work does not identify which analgesic agent within the multimodal bundle is most effective. However, we assume that the noxious stimuli from this surgery are so great that it is unlikely that any 1 agent can produce a profound analgesic benefit in isolation; it is the combination of medications that enable early mobilization while maintaining effective analgesia and minimizing adverse effects. Earlier research demonstrating that individual nonopioid analgesics can provide modest but limited improvement in pain after PSF supports this assumption. We have not reported on opioid related side effects such as nausea and vomiting because these outcomes were difficult to reliably extract from the medical records. Finally, although we report the rate of ED visits/readmissions after discharge, we only present data on return visits to our hospital and cannot account for return visits/hospitalizations elsewhere. The incidence of this is likely low because patients are typically directed to our hospital for postoperative complication management.
Implications for Practice
The results of this QI project reinforce findings that pediatric patients can be mobilized and discharged earlier after PSF9 and add to this work by demonstrating how multimodal analgesic strategy can facilitate early discontinuation of intravenous opioids while maintaining effective analgesia. Standardization of care reduces practice variability and allows for meaningful assessment of outcomes in specific patient populations by creating shared baseline process, outcome, and balancing metrics. This multidisciplinary improvement approach to perioperative care can be applied to other pediatric surgical populations in which significant postoperative pain and morbidity is expected, such as PSF for neuromuscular scoliosis or adolescents undergoing correction of pectus excavatum.
We thank the many people who helped make this quality improvement project possible. Specifically, Blair Kraus, our improvement advisor, and Ethan Jacobi, our data analyst, were instrumental in the coordination and execution of this improvement project. Additionally, we thank the nurses and PT team on the surgical floor who made the implementation of our protocol possible.
- Accepted October 16, 2015.
- Address correspondence to Wallis T. Muhly, MD, Department of Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, Perelman School of Medicine at the University of Pennsylvania, 34th St & Civic Center Blvd, Main Building, 9th Floor, Suite 9329, Philadelphia, PA 19104. E-mail: .
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
FUNDING: This research was supported through internal funds from the Children’s Hospital of Pennsylvania Department of Anesthesiology and Critical Medicine as well as the Division of Orthopedic Surgery. In addition, we applied for and received support from The Children’s Hospital of Pennsylvania Office of Clinical Quality Improvement, which provided an improvement advisor and a data analyst to facilitate this improvement project.
POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no conflicts of interest to disclose.
- Munro HM,
- Walton SR,
- Malviya S, et al.
- Sinatra RS,
- Jahr JS,
- Reynolds LW,
- Viscusi ER,
- Groudine SB,
- Payen-Champenois C
- Provost LP,
- Murray SK
- Dahl JB,
- Nielsen RV,
- Wetterslev J, et al; Scandinavian Postoperative Pain Alliance (ScaPAlli)
- Copyright © 2016 by the American Academy of Pediatrics