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Brittany E. Haws, Benjamin Khechen, Ankur S. Narain, Fady Y. Hijji, Daniel D. Bohl, Dustin H. Massel, Benjamin C. Mayo, Junyoung Ahn and Kern Singh

OBJECTIVE

Intraoperative local steroid application has been theorized to reduce swelling and improve swallowing in the immediate period following anterior cervical discectomy and fusion (ACDF). Therefore, the purpose of this study was to quantify the impact of intraoperative local steroid application on patient-reported swallow function and swelling after ACDF.

METHODS

A prospective, randomized single-blind controlled trial was conducted. A priori power analysis determined that 104 subjects were needed to detect an 8-point difference in the Quality of Life in Swallowing Disorders (SWAL-QOL) questionnaire score. One hundred four patients undergoing 1- to 3-level ACDF procedures for degenerative spinal pathology were randomized to Depo-Medrol (DEPO) or no Depo-Medrol (NODEPO) cohorts. Prior to surgical closure, patients received 1 ml of either Depo-Medrol (DEPO) or saline (NODEPO) applied to a Gelfoam carrier at the surgical site. Patients were blinded to the application of steroid or saline following surgery. The SWAL-QOL questionnaire was administered both pre- and postoperatively. A ratio of the prevertebral swelling distance to the anteroposterior diameter of each vertebral body level was calculated at the involved levels ± 1 level by using pre- and postoperative lateral radiographs. The ratios of all levels were averaged and multiplied by 100 to obtain a swelling index. An air index was calculated in the same manner but using the tracheal air window diameter in place of the prevertebral swelling distance. Statistical analysis was performed using the Student t-test and chi-square analysis. Statistical significance was set at p < 0.05.

RESULTS

Of the 104 patients, 55 (52.9%) were randomized to the DEPO cohort and 49 (47.1%) to the NODEPO group. No differences in baseline patient demographics or preoperative characteristics were demonstrated between the two cohorts. Similarly, estimated blood loss and length of hospitalization did not differ between the cohorts. Neither was there a difference in the mean change in the scaled total SWAL-QOL score, swelling index, and air index between the groups at any time point. Furthermore, no complications were observed in either group (retropharyngeal abscess or esophageal perforation).

CONCLUSIONS

The results of this prospective, randomized single-blind study did not demonstrate an impact of local intraoperative steroid application on patient-reported swallowing function or swelling following ACDF. Neither did the administration of Depo-Medrol lead to an earlier hospital discharge than that in the NODEPO cohort. These results suggest that intraoperative local steroid administration may not provide an additional benefit to patients undergoing ACDF procedures.

■ CLASSIFICATION OF EVIDENCE Type of question: therapeutic; study design: randomized controlled trial; evidence: Class I.

Clinical trial registration no.: NCT03311425 (clinicaltrials.gov)

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Benjamin C. Mayo, Dustin H. Massel, Daniel D. Bohl, Ankur S. Narain, Fady Y. Hijji, William W. Long, Krishna D. Modi, Bryce A. Basques, Alem Yacob and Kern Singh

OBJECTIVE

Prior studies have correlated preoperative depression and poor mental health status with inferior patient-reported outcomes following lumbar spinal procedures. However, literature regarding the effect of mental health on outcomes following cervical spinal surgery is limited. As such, the purpose of this study is to test for the association of preoperative SF-12 Mental Component Summary (MCS) scores with improvements in Neck Disability Index (NDI), SF-12 Physical Component Summary (PCS), and neck and arm pain following anterior cervical discectomy and fusion (ACDF).

METHODS

A prospectively maintained surgical database of patients who underwent a primary 1- or 2-level ACDF during 2014–2015 was reviewed. Patients were excluded if they did not have complete patient-reported outcome data for the preoperative or 6-week, 12-week, or 6-month postoperative visits. At baseline, preoperative SF-12 MCS score was assessed for association with preoperative NDI, neck visual analog scale (VAS) score, arm VAS score, and SF-12 PCS score. The preoperative MCS score was then tested for association with changes in NDI, neck VAS, arm VAS, and SF-12 PCS scores from the preoperative visit to postoperative visits. These tests were conducted using multivariate regression controlling for baseline characteristics as well as for the preoperative score for the patient-reported outcome being assessed.

RESULTS

A total of 52 patients were included in the analysis. At baseline, a higher preoperative MCS score was negatively associated with a lower preoperative NDI (coefficient: −0.74, p < 0.001) and preoperative arm VAS score (−0.06, p = 0.026), but not preoperative neck VAS score (−0.03, p = 0.325) or SF-12 PCS score (0.04, p = 0.664). Additionally, there was no association between preoperative MCS score and improvement in NDI, neck VAS, arm VAS, or SF-12 PCS score at any of the postoperative time points (6 weeks, 12 weeks, and 6 months, p > 0.05 for each). The percentage of patients achieving a minimum clinically important difference at 6 months did not differ between the bottom and top MCS score halves (p > 0.05 for each).

CONCLUSIONS

The results of this study suggest that better preoperative mental health status is associated with lower perceived preoperative disability but is not associated with severity of preoperative neck or arm pain. In contrast to other studies, the present study was unable to demonstrate that preoperative mental health is predictive of improvement in patient-reported outcomes at any postoperative time point following an ACDF.

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Brittany E. Haws, Benjamin Khechen, Dil V. Patel, Mundeep S. Bawa, Junyoung Ahn, Daniel D. Bohl, Benjamin C. Mayo, Dustin H. Massel, Jordan A. Guntin, Kaitlyn L. Cardinal and Kern Singh

OBJECTIVE

Local epidural steroid application may be associated with decreased pain and narcotic use in the immediate postoperative period following lumbar discectomy. However, local steroid delivery following lumbar fusion procedures has not been well characterized. This study aims to characterize the effect of local intraoperative depomedrol application on perioperative and postoperative outcomes following a single-level minimally invasive transforaminal lumbar interbody fusion (MIS TLIF).

METHODS

A prospective, randomized, single-blinded study was performed. A priori power analysis determined that 86 patients were needed to detect a difference of 1 point in the visual analog scale (VAS) pain score between groups. Ninety-three patients were randomized into depomedrol (DEPO) and no depomedrol (NODEPO) cohorts. Prior to surgical closure, DEPO patients received 1 ml depomedrol (80 mg) applied directly to the surgical site by using a Gelfoam carrier. NODEPO patients received 1 ml saline on the same Gelfoam carrier. Perioperative outcomes including acute postoperative pain and narcotic use were assessed for the duration of inpatient stay. Patient-reported outcomes (PROs) questionnaires including VAS back and leg pain scores, and Oswestry Disability Index (ODI) were administered preoperatively and at 6-week, 12-week, and 6-month follow-up. Outcomes for DEPO and NODEPO cohorts were compared using linear regression controlled for sex.

RESULTS

Of the 93 patients, 45 (48.4%) were randomized to DEPO and 48 (51.6%) to NODEPO. A greater percentage of DEPO patients were female (53.3% vs 27.1%, p = 0.010). There were no other significant differences in patient baseline characteristics. Similarly, operating time, estimated blood loss, and length of inpatient stay did not differ between cohorts. Patients in the DEPO cohort consumed fewer hourly narcotics on postoperative day 0 (5.3 vs 6.3 oral morphine equivalents/hour, p = 0.034). However, no differences in acute postoperative pain or total narcotics consumption were observed between groups. Preoperative VAS leg scores were statistically different between cohorts (p = 0.027). However, preoperative ODI and VAS back scores did not differ between groups. Additionally, DEPO and NODEPO groups experienced similar improvements in PROs at all postoperative time points.

CONCLUSIONS

Local depomedrol use did not lead to decreases in acute postoperative pain or narcotics consumption after MIS TLIF. Additionally, local depomedrol was not associated with postoperative improvements in PROs. The findings of this randomized trial suggest that surgical and clinical outcomes following MIS TLIF may not be impacted by intraoperative application of depomedrol.

Clinical trial registration no.: NCT03308084 (clinicaltrials.gov)

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Brittany E. Haws, Benjamin Khechen, Dil V. Patel, Mundeep S. Bawa, Junyoung Ahn, Daniel D. Bohl, Benjamin C. Mayo, Dustin H. Massel, Jordan A. Guntin, Kaitlyn L. Cardinal and Kern Singh

OBJECTIVE

Local epidural steroid application may be associated with decreased pain and narcotic use in the immediate postoperative period following lumbar discectomy. However, local steroid delivery following lumbar fusion procedures has not been well characterized. This study aims to characterize the effect of local intraoperative depomedrol application on perioperative and postoperative outcomes following a single-level minimally invasive transforaminal lumbar interbody fusion (MIS TLIF).

METHODS

A prospective, randomized, single-blinded study was performed. A priori power analysis determined that 86 patients were needed to detect a difference of 1 point in the visual analog scale (VAS) pain score between groups. Ninety-three patients were randomized into depomedrol (DEPO) and no depomedrol (NODEPO) cohorts. Prior to surgical closure, DEPO patients received 1 ml depomedrol (80 mg) applied directly to the surgical site by using a Gelfoam carrier. NODEPO patients received 1 ml saline on the same Gelfoam carrier. Perioperative outcomes including acute postoperative pain and narcotic use were assessed for the duration of inpatient stay. Patient-reported outcomes (PROs) questionnaires including VAS back and leg pain scores, and Oswestry Disability Index (ODI) were administered preoperatively and at 6-week, 12-week, and 6-month follow-up. Outcomes for DEPO and NODEPO cohorts were compared using linear regression controlled for sex.

RESULTS

Of the 93 patients, 45 (48.4%) were randomized to DEPO and 48 (51.6%) to NODEPO. A greater percentage of DEPO patients were female (53.3% vs 27.1%, p = 0.010). There were no other significant differences in patient baseline characteristics. Similarly, operating time, estimated blood loss, and length of inpatient stay did not differ between cohorts. Patients in the DEPO cohort consumed fewer hourly narcotics on postoperative day 0 (5.3 vs 6.3 oral morphine equivalents/hour, p = 0.034). However, no differences in acute postoperative pain or total narcotics consumption were observed between groups. Preoperative VAS leg scores were statistically different between cohorts (p = 0.027). However, preoperative ODI and VAS back scores did not differ between groups. Additionally, DEPO and NODEPO groups experienced similar improvements in PROs at all postoperative time points.

CONCLUSIONS

Local depomedrol use did not lead to decreases in acute postoperative pain or narcotics consumption after MIS TLIF. Additionally, local depomedrol was not associated with postoperative improvements in PROs. The findings of this randomized trial suggest that surgical and clinical outcomes following MIS TLIF may not be impacted by intraoperative application of depomedrol.

Clinical trial registration no.: NCT03308084 (clinicaltrials.gov)