Effect of Cryoablation in Nuss Bar Placement on Opioid Utilization and Length of Stay

doi:10.21203/rs.3.rs-4720721/v1

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Effect of Cryoablation in Nuss Bar Placement on Opioid Utilization and Length of Stay

https://doi.org/10.21203/rs.3.rs-4720721/v1

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BACKGROUND

Our institution recently transitioned from paravertebral nerve blocks (PVB) to intercostal nerve cryoablation (INC) for pain control following minimally invasive repair of pectus excavatum (MIRPE). This study aimed to determine how INC affected the operative time, length of stay, complication rates, inpatient opioid use, and outpatient prescription of opioids at a single center.

METHODS

A retrospective review was performed at a single pediatric referral center of all patients who underwent MIRPE between 2018–2023. Patient demographics, operative details, and perioperative course were collected. The use of INC versus PVB was recorded. Univariate analyses were performed using Wilcoxon rank sum tests for continuous variables and chi-squared tests for categorical variables.

RESULTS

255 patients were included with a median age of 15 years, median BMI of 18.50 kg/m², and median Haller index of 4.40. INC was utilized in 41% (105/255), and 59% (150/255) received PVB. The two groups did not differ significantly in BMI, Haller index, or complications, though the INC patients were older by 1 year (15.0 vs 16.0, p = 0.034). INC was associated with an increased operative time (INC: 92 min vs. PVB: 67 min, p < 0.001), decreased length of stay (3 vs. 4 days, p = < 0.001), more than 2-fold decrease in inpatient opioids per day (INC: 16 (MME) vs PVB 41 (MME), p < 0.001), and a four-fold decrease in the amount of opioids prescribed at discharge (INC: 90 MME) vs PVB 390 MME, p < 0.001).

CONCLUSION

INC after MIRPE significantly decreased both the inpatient opioid utilization and our outpatient prescribing practices while also decreasing our overall length of stay without increasing complications.

Level of Evidence: Level III

Nuss Bar

Pectus Excavatum

Cryoablation

Opioids

Pectus excavatum (PE) is the most common congenital chest wall abnormality affecting adolescents.^1,2 PE results in an inward depression of the sternum and may lead to a decrease in cardiopulmonary fitness and result in psychosocial distress. ^3–5 Surgical correction of PE is commonly carried out via the Nuss procedure or the minimally invasive repair of pectus excavatum (MIRPE).^6–8 During MIRPE, a concave metal bar is placed behind the sternum and rotated into place resulting in an immediate remodeling of the chest wall resulting in significant postoperative pain. Multiple management strategies have been proposed to mitigate postoperative pain following MIRPE including paravertebral nerve blocks (PVB), thoracic epidurals, elastomeric pain pumps, patient-controlled anesthesia, and multimodal pain regimens. Despite these analgesia adjuncts, MIRPE is associated with prolonged hospitalization and high opioid requirements. ^9–12 With the current epidemic of opioid use and dependence, the use of cryoablation has gained popularity as an opioid-sparing analgesic that outlasts injections and catheter-based delivery of opioids in the postoperative period.^13–16 Intercostal nerve cryoablation (INC) during MIRPE was first reported in 2016 by Keller et al. and has been shown to decrease hospital length of stay and inpatient opioid use when compared to other analgesic strategies. However, there is a paucity of data assessing MIRPE’s effect on long-term opioid use and requirements.^15,17

Previous studies have shown that cryoablation for pain management after MIRPE is associated with decreased length of stay and opioid use by patients.^{17,18 19–21} A 2023 literature review by Eldredge et al. found that the majority of studies examining the influence of INC and opioid use did not account for the length of stay (LOS) in the non-INC cohort when reporting opioid use and instead used total hospital MME opioid use. This makes it difficult to assess whether patients are actually needing fewer opioids, or if they are just leaving the hospital sooner. ⁴ Additionally, only half of the studies reviewed by Eldredge et al. reported the complications associated with cryoablation, and most studies contained fewer than 60 patients who had undergone cryoablation. Given the increasingly widespread use of cryoablation, more extensive research is needed to examine the influence of INC on MIRPE.

The primary aim of this study was to evaluate opioid use both in hospital and outpatient between patients who received INC versus PVB following MIRPE. Secondarily, we aimed to assess if there was a difference in operative time, hospital length of stay, and incidence of complications between those who received INC and PVB. We hypothesized that patients who received INC would be discharged with fewer opioids in comparison to those who received PVB and have lower per-day inpatient opioid use.

This study was approved by the University of Utah IRB and followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guidelines.

Study Design and Data Source

Following institutional review, we conducted a retrospective review of pediatric, ≤ 21 years old, who underwent MIRPE from January 2018 to July 2023 at a single tertiary pediatric chest wall referral center. Patients were excluded from the study if MIRPE was performed for recurrent PE, or if they underwent a concomitant chest wall procedure. Demographic, biometric, intraoperative, and hospital course data were collected.

INC was introduced at our facility as a pain adjuvant during MIRPE in June of 2021. Prior to INC, PVBs were used routinely by all of our surgeons. Between June 2021 and June 2022 either INC or PVB were used under the discretion of the operating surgeon. Following June 2022 INC was exclusively used by all surgeons during MIRPE. During the study period, our postoperative pain regimen did not change. Following MIRPE and while hospitalized, patients were routinely placed on scheduled on acetaminophen per os (PO) acetaminophen and ibuprofen PO or Toradol IV. For breakthrough pain, oxycodone PO or Hydromorphone IV were provided pro re nata (PRN). Patients were discharged with instructions to continue acetaminophen and ibuprofen and prescribed Oxycodone five-mg tablets for breakthrough pain. If patients received a PVB catheter during MIRPE they were discharged with the catheter in place and provided instructions to remove the catheter on post-operative day five.

Inpatient opioid use was determined from the medication administration record (MAR) and was measured in milligrams. Outpatient opioids were calculated from the number of doses in milligrams prescribed on discharge. Opioids were converted to morphine equivalents utilizing the CDC Opioid Oral Morphine Milligram Equivalent (MME) Conversion Factors table.²² MME per day for both INC and PVB cohorts were calculated using total inpatient MME and dividing by the LOS. Postoperative MIRPE complications were defined as surgical site infections (SSI), wound dehiscence, wound hematoma or seroma requiring drainage, delayed pneumothorax requiring chest tube placement, pectus bar displacement, neuropathic pain requiring medication treatments, brachial plexus injury, and pain requiring pectus bar removal or stabilizer removal. SSI was defined as a documented infection adjacent to the surgical incision requiring antibiotics or operative intervention within 30 days of MIRPE. Operating time was determined based on procedure start time or incision time and wound closure time.

Statistical Analysis

Descriptive statistics were used to characterize patient demographics, intraoperative course, postoperative opioid requirements and postoperative outcomes. Continuous variables were expressed in medians with interquartile ranges, and categorical variables were expressed as frequencies or percentages. Univariate analyses were performed using Wilcoxon rank sum tests for continuous variables and chi-squared tests for categorical variables. All statistical analyses were performed using R (Version 4.3.1).²³ Hypotheses were tested using a two-sided approach, with p < 0.05 considered statistically significant.

During the study period, 260 patients underwent MIRPE (See Table 1). Of these patients, 255 met the inclusion criteria. Five were excluded due to bar reinsertion following bar infection (2), bar displacement (2), and unsatisfactory results (1). Most subjects were non-Hispanic White (88%) and male (83%), with a median age of 15 years old [IQR:14–16], and a BMI of 18.50 kg/m² [IQR: 7.14–19.82]. INC was performed in 41% (105/255) of subjects. There were no differences in patient sex, height, weight, BMI, race, or complication rate between patients who received cryoablation and PVB (Table 3).

Compared to the PVB cohort, the INC cohort received fewer MME per day in the hospital (16 MME vs. 41 MME; p < 0.001), had a decreased LOS (3 days vs. 4 days, p < 0.001, and were prescribed fewer opioids at hospital discharge (90 MME vs. 390 MME or 12 five-mg oxycodone tablets vs 52 five-mg oxycodone tablets; p-value = < 0.001). The overall incidence of complications following INC was 13.3% compared to 9.3% for PVB (p = 0.31). No significant differences were observed between cohorts for neuropathic pain (PVB = 0%, INC = 2.9%, p = 0.069), SSI (PVB = 6.7%, INC = 3.8%, p = 0.32), pectus bar displacement (PVB = 0.7%, INC = 1.9%, p = 0.37), brachial plexus injuries (PVB = 0%, INC = 1.9%, p = 0.2), pneumothoraxes (PVB = 1.3%, INC = 0.9%, p = 0.78), seroma requiring operation (PVB = 0, INC = 0.9%, p = 0.4), or hematoma requiring operation (PVB = 0, INC = 0.9%, p = 0.4) (see Table 2).

Table 1

Demographics
Characteristic	N = 255¹
Cryoablation
Cryoablation not utilized (PVB)	150 (59%)
Cryoablation performed (INC)	105 (41%)
Race
American Indian	1 (0.4%)
Hispanic	28 (11%)
NA	1 (0.4%)
Pacific Islander	1 (0.4%)
White	224 (88%)
Sex
F	44 (17%)
M	211 (83%)
Age	15.00 (14.00, 16.00)
BMI	18.50 (17.14, 19.82)
Haller	4.40 (3.84, 5.71)
Unknown	3

Table 1: This table demonstrates the demographic characteristics of both groups. Continuous data are shown as Median (interquartile range) and discrete data is shown as N (%). PVB = Paravertebral block, INC = Intercostal nerve cryoablation, NA = Not applicable, F = female, M = Male, BMI = body mass index

Table 2

Complications
Characteristic	PVB, N = 150¹	INC, N = 105¹	p-value²
Complication	14 (9.3%)	14 (13.3%)	0.31
Infection	10 (6.7%)	4 (3.8%)	0.32
Infection requiring antibiotics	5 (3.3%)	2 (1.9%)	0.49
Infection requiring washout + antibiotics	3 (2.0%)	2 (1.9%)	> 0.9
Infection requiring sidebar removal	1(0.7%)	0 (0%)	> 0.9
Infection requiring Nuss Bar removal	1(0.7%)	0 (0%)	> 0.9
Pain requiring intervention	0 (0%)	3 (2.9%)	0.069
Pneumothorax requiring chest tube	2 (1.3%)	1 (0.9%)	0.78
Brachial plexus injury	0 (0%)	2 (1.9%)	0.2
Fractured Pericostal wire requiring Requiring nuss removal	1(0.7%)	0 (0%)	> 0.9
Nuss Bar Shift requiring removal	1 (0.7%)	2 (1.9%)	0.37
Hematoma	0 (0%)	1 (0.9%)	0.4
Seroma	0 (0%)	1 (0.9%)	0.4

Table 2: This table demonstrates the complication characteristics of both groups. Continuous data are shown as Mediant (interquartile range) and discrete data is shown as N (%). PVB = Paravertebral block, INC = Intercostal nerve cryoablation,

Table 3

PVB vs INC
Characteristic	PVB, N = 150¹	INC, N = 105¹	p-value²
Race			0.3
American Indian	0 (0%)	1 (1.0%)
Hispanic	16 (11%)	12 (11%)
NA	0 (0%)	1 (1.0%)
Pacific Islander	0 (0%)	1 (1.0%)
White	134 (89%)	90 (86%)
Sex			0.3
F	23 (15%)	21 (20%)
M	127 (85%)	84 (80%)
Age	15.00 (14.00, 16.00)	16.00 (14.00, 17.00)	0.034
BMI	18.50 (17.12, 19.79)	18.48 (17.16, 19.84)	> 0.9
Haller	4.40 (3.90, 5.38)	4.40 (3.84, 5.80)	0.9
Unknown	0	3
Opioid Use	149 (99%)	101 (96%)	0.2
Discharge Morphine equivalents (MME)	390 (225, 525)	90 (75, 150)	< 0.001
Inpatient Morphine Equivalents (MME)	175 (121, 254)	39 (17, 68)	< 0.001
Morphine equivalents per day (MME)	41 (28, 56)	16 (7, 23)	< 0.001
Complications	19 (13%)	20 (19%)	0.2
LOS	4.00 (4.00, 5.00)	3.00 (2.00, 3.00)	< 0.001
Operative time	67 (59, 81)	92 (82, 108)	< 0.001
¹ n (%); Median (IQR) ² Fisher’s exact test; Pearson’s Chi-squared test; Wilcoxon rank sum t

Table 3: This table demonstrates the demographic characteristics between both groups. Continuous data are shown as Median (interquartile range) and discrete data is shown as N (%). PVB = Paravertebral block, INC = Intercostal nerve cryoablation, NA = Not applicable, F = female, M = Male, BMI = body mass index, LOS = Length of stay, MME = Milligram Morphine Equivalents

In the current study, we describe the impact of INC during MIRPE compared to PVBs. We observed that patients who received INC had a decrease in overall opioid use during hospitalization, daily opioid use, and prescription opioids at discharge compared to those who had PVB as part of their care. While INC was associated with increased operative times, it was also found to reduce hospital LOS by one day and was not associated with an increased incidence of postoperative complications.

Our findings on the effects that INC has on inpatient opioid use and hospital LOS following MIRPE compared to other analgesic strategies including thoracic epidurals, elastomeric pain pumps, and multimodal pain regimens, are consistent with previous reports. However, there is little reported comparing outcomes between patients who received INC and PVB during MIRPE. In 2023, Akinboro et al. report on their experience using INC during MIRPE compared to PVB.²⁴ Using a prospective methodology, they compared 17 patients who had INC during MIPRE to a historic cohort with PVB; they found that patients with INC had a significant decrease in hospital LOS and 10-fold reduction in inpatient opioid use. Despite the favorable findings of INC, this study was underpowered. In our study, we observed an approximate 2.5-fold decrease in opioid use per hospital day. Zeinneddin et al. had similar findings when reviewing 198 patients who underwent MIRPE with either INC or PVB, observing that the INC cohort had a five-fold reduction in opioid use per day than those with PVB alone. The results of these studies suggest that INC significantly decreases the amount of inpatient opioid requirement compared to PVB.

Additionally, we observed a significant decrease in outpatient opioid prescriptions with the use of INC compared to PVBs. This study adds to the knowledge of INC use in MIRPE as it assesses one of the largest cohorts of patients receiving INC. Additionally, while other studies have looked at opioid use in the hospital following cryoablation, few have adjusted for the shortened LOS in the non-cryoablation group in their studies. While it was known that INC led to decreased total opioid use while in the hospital, no studies had assessed whether this change was secondary to the shorter length of stay in INC patients. When accounting for the longer length of stay in the non-cryoablation group, the non-cryoablation group used more than double the opioids compared to the INC group. This result suggests that the decrease in opioid use in the cryoablation group isn’t just a product of quicker discharges, but that cryoablation is effective in decreasing pain postoperatively. Furthermore, our study demonstrated that fewer opioids are prescribed upon release from the hospital in the INC group. Data demonstrating that INC decreases the reliance on opioids for pain control may encourage surgeons to prescribe less. A study by Lai et al. compared patients who received INC in the earliest quarter after its implementation to those who received it three quarters later. The findings indicated that patients in the later group were discharged earlier and required fewer opioids both during their hospital stay and upon discharge.²⁵ These findings imply that as surgeons and centers become more comfortable with INC procedures, future INC procedures may require even fewer opioids.

Furthermore, other studies have had results consistent with our finding that LOS is decreased in patients who undergo cryoablation for Nuss procedures. Holguin et al. compared patients utilizing INC to those who used thoracic epidural for pain management undergoing the Nuss procedure and found a two-day shorter length of stay in the INC group compared to the epidural group. Song et al. also reported that INC appears to reduce post-operative hospital stay.²⁶ Additionally, while the difference in length of stay between the groups was significant at one day, more patients were being discharged on POD 1 as surgeon familiarity with INC improved over the course of this study. We expect that as familiarity increases, this gap will continue to widen. Our study’s findings and previous literature suggest that improved pain control provided by INC decreases the length of postoperative hospital stay.

Our study found that one drawback of INC is that it adds operating time. This is not surprising given that during the INC procedure, intercostal nerves from the 3rd to the 8th nerve bilaterally are ablated for two minutes each. Our finding is supported by Cockrell et al., who reported a similar result that INC increased operative time by 26 minutes.²⁷ Other studies by Clark et al. and Rettig et al. also showed INC increased operative time.^28,29 However, Rettig et al. did not find a significant difference in total operating room time when comparing the two groups even though there was a difference in actual operative time.²⁰ This study supports previous findings in the literature that INC does add operative time, however, we did not account for total time in the operating room which is likely similar considering the time needed to place PVBs. With this increased operating time and device utilization, there is some concern that INC may be more expensive than other pain management methods. However, in our cost analysis, we gathered cost data for 200 patients in our study and found that the reduced length of stay for patients in the INC group, compared to the PVB group, resulted in an average reduction in gross charges of $8,052 per patient. Extrapolating this to an average of 55 Nuss procedure cases per year, utilizing INC would lead to a total gross charge reduction of $442,859 annually.This supports previous studies by Aiken et al. and Rettig et al. that showed INC was associated with lower costs than PVB and further supports the adoption of INC in Nuss procedures.^20,21

Our study found that complications were not significantly different when comparing patients who received cryoablation to those who received PVBs. This finding was supported by the literature review by Eldredge et al., which found that the overall complication rate was either significantly lower or no difference between the INC and non-INC cohorts.⁴ While our study reported a slightly higher complication rate compared to other studies, we have implemented several practices to reduce this rate, including a comprehensive infection prevention protocol. Notably, all brachial plexus injuries in the INC group have fully recovered. The extended OR time may have contributed to these injuries. Following the last recorded injury, we adjusted patient positioning by placing the arms by the side, and we have not had any subsequent injuries since. Furthermore, while the INC group did have more pain-requiring intervention that approached significance (p = 0.069), the intervention in all 3 cases was sidebar removal. Of note, one surgeon in our practice stopped using sidebars as it was thought to be contributing to pain independent of cryoablation. In summary, pain management modality does not affect the complication rate following MIRPE.

There are several significant limitations to this study. First, this retrospective review was conducted at a single institution. Thus, the generalizability of the findings may be limited. Additionally, patients were not randomized into the cryoablation or no cryoablation group; the decision to utilize was made by the attending surgeon. Additionally, opioid prescribing patterns differ between surgeons. This aspect of the study design makes it difficult to determine the exact nature of the relationship between cryoablation and opioid prescription patterns and inherently biases the study as differences in surgeons introduce multiple confounding factors. Multiple techniques in operative procedure, infection prevention, and positioning changed over the study period which also has the potential to bias our results. Finally, it may be hard to assess precisely what role INC has on opioid use. It should be noted that a general encouragement to reduce opioids with recognition of a national pandemic coincided with the institution of INC. The retrospective nature of this study made it impossible to determine the actual home opioid usage. Opioids on discharge may be more of an indication of provider willingness to prescribe and not a true measure of patient opioid use. While we cannot determine causation, the shift to cryoablation was associated with a change in practice which is beneficial to the patient.

In this retrospective cohort study, we found that following a transition to INC as a pain management strategy after MIRPE there was a significant decrease in both the inpatient opioid utilization and our outpatient prescribing practices. This occurred while decreasing our overall length of stay without increasing complications. This adds to a growing body of evidence that INC reduces pain after MIRPE and supports the universal adoption of this practice.

Funding:

Author Contribution

Christopher Clinker – Contributed to the writing, editing, chart reviewing, and idea creationJack Scaife - Contributed to the writing, editing, chart reviewing, and idea creation Richard Scott Eldredge - Contributed to the writing, editing, chart reviewing, and idea creation Katie W. Russell – Contributed to editing, chart reviewing, and idea creation

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No competing interests reported.

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Effect of Cryoablation in Nuss Bar Placement on Opioid Utilization and Length of Stay

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