Local Retropharyngeal Space Anesthetic for Dysphagia Reduction after Anterior Cervical Discectomy and Fusion Surgery: A Single-Center, Prospective, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

OBJECTIVE: The main objective of this study was to analyze the ability of local anesthetic instillation into the retropharyngeal space to reduce dysphagia symptoms and occurrence rates in patients undergoing anterior cervical discectomy and fusion (ACDF) procedures. METHODS: A single-center, prospective, randomized, double-blinded, and placebo-controlled clinical study was performed. We enrolled patients undergoing one- or two-level ACDF procedures for cervical degenerative disc disease with disc herniation, radiculopathy and/or myelopathy symptoms. The patients were randomly assigned (1:1 ratio) to receive either 0.5% bupivacaine hydrochloride or 0.9% NaCl solution. RESULTS: Forty-three (74%) and 41 (77%) of patients reported dysphagia symptoms at the time of discharge in the investigational and control groups, respectively. There were no statistically significant differences in duration of dysphagia symptoms, Swallowing-Quality of Life (SWAL-QOL) survey or pain scores between the investigational and control patient groups at any of the follow-up time points. Controlling for independent variables, only younger age significantly predicted dysphagia symptoms at discharge, 2-week, and 3-month follow-ups (P ≤ 0.03; R ≥ -0.038; OR 0.96, 95% CI 0.93-0.99. Female sex was associated with lower SWAL-QOL scores at discharge (P = 0.046; R = 0.87; OR 2.38, 95% CI 1.02-5.56). A total of 8 (13.8%) and 6 (11.3%) patients in the investigational and control groups, respectively, were referred to a specialist or underwent speech therapy for their dysphagia symptoms. There were no adverse reactions to the study drug observed. CONCLUSIONS: Local retropharyngeal space anesthetic instillation did not reduce dysphagia symptoms or occurrence rates in patients undergoing anterior discectomy and fusion surgeries.

The Impact of Preventative Multimodal Analgesia on Postoperative Opioid Requirement and Pain Control in Patients Undergoing Lumbar Fusions.

STUDY DESIGN: A prospective observational study with a historical reference group. OBJECTIVES: The main objectives of this study were to determine the impact of preventative multimodal analgesia (PMA) on postoperative opioid requirements and analgesic effectiveness in patients undergoing lumbar fusion surgery. SUMMARY OF BACKGROUND DATA: PMA addresses the multiple pathways of acute and chronic pain by interfering with peripheral and central sensitization and should provide a way to achieve safer and more effective pain management with reduced opioid medication use. MATERIALS AND METHODS: This study compared postoperative opioid requirement and analgesic effect in a total of 101 patients undergoing elective, 1-level or 2-level transforaminal lumbar interbody fusion surgeries for symptomatic lumbar degenerative disk disease. The PMA patient group included 51 consecutive patients who received 1000 mg of acetaminophen, 300-900 mg of gabapentin, and 200-400 mg of celecoxib 1 hour before their index procedure. The reference group included 50 patients who received 15 mg of morphine-equivalent dose (MED) preoperatively.Multiple linear regression was used to evaluate the effect of PMA on postoperative pain and MED over 4 postoperative days, while controlling for all variables likely to influence these outcomes, including age, sex, baseline opioid use, duration of surgery, postoperative intrathecal morphine use and the administration of muscle relaxants and anticonvulsants. RESULTS: The differences in opioid requirement and postoperative pain scores were statistically significant on all 4 postoperative days. The effect size varied from -0.54 to -0.99 (34.8%-54.2% MED reduction) for the postoperative opioid requirement and from -0.59 to -1.16 (28.9%-37.3% visual analog scale reduction) for postoperative pain indicating that these measures were reduced by about ½ to 1 SD in the PMA patient group. CONCLUSIONS: PMA is a highly effective and safe method for postoperative pain management in patients undergoing elective lumbar fusion surgeries by improving pain control and reducing opioid requirement. LEVEL OF EVIDENCE: Level III.

Prospective randomized feasibility study comparing manual vs. automatic position-adaptive spinal cord stimulation with surgical leads.

BACKGROUND: The majority of patients experience uncomfortable stimulation associated with posture changes, especially when lying down. The spinal cord moves within the intrathecal space in response to positional changes affecting the size of the stimulated area accordingly and causing overstimulation or understimulation. To accommodate for positional changes, patients have to manually adjust the stimulation parameters; therefore, an automatic position-adaptive SCS was designed to address these issues. The primary objective of this study was to establish the extent of position-related variations in SCS stimulation parameters experienced by chronic pain patients implanted with surgical, laminectomy-type leads under both automatic and manual SCS conditions. METHODS: A total of 18 patients completed a single-center, prospective, non-blinded, randomized (1:1), feasibility clinical study with a two-arm crossover design. All patients undergoing SCS treatment for chronic refractory back and or leg pain associated with failed back surgery, post-laminectomy, or radicular pain syndromes that were refractory to conservative and surgical interventions were eligible for enrollment. After the manual stimulation mode, the patients were randomized to one of two study arms: manual or automatic position-adaptive stimulation and then crossed over to a different arm. All patients were followed for a total of 5 months (± 2 weeks). RESULTS: Analysis indicated statistically significant differences between therapeutic and threshold stimulation intensity for the supine position compared with all other body positions when using either automatic position-adaptive stimulation or manual stimulation, except for threshold amplitudes in the prone position for automatic stimulation. CONCLUSION: Similar variations were reported for manual and automatic stimulation intensity in response to positional changes.

Prediction based on preoperative opioid use of clinical outcomes after transforaminal lumbar interbody fusions.

OBJECTIVE Opioid analgesics have become some of the most prescribed drugs in the world, despite the lack of long-term studies evaluating the benefits of opioid medications versus their risks associated with chronic use. In addition, long-term opioid use may be associated with worse long-term clinical outcomes. The primary objective of this study was to evaluate whether preoperative opioid use predicted inferior clinical outcomes among patients undergoing transforaminal lumbar interbody fusion (TLIF) for symptomatic lumbar degenerative disc disease. METHODS The authors of this observational study prospectively enrolled 93 patients who underwent 1-level to 2-level TLIFs in 2011-2014; the patient cohort was divided into 2 groups according to preoperative opioid use or no such use. Visual analog scale (VAS) scores for low-back pain and leg pain, Oswestry Disability Index scores, and the scores of the mental component summary (MCS) and physical component summary (PCS) on the 36-Item Short Form Health Survey were used to assess pain, disability, and health-related quality of life outcomes, respectively. The clinical scores for the 2 groups were determined preoperatively and at a 12-month follow-up examination. RESULTS In total, 60 (64.5%) patients took prescribed opioid medications preoperatively. Compared with those not taking opioids preoperatively, these patients had significantly higher VAS scores for low-back pain (p = 0.016), greater disability (p = 0.013), and lower PCS scores (p = 0.03) at the 12-month follow-up. The postoperative MCS scores were also significantly lower (p = 0.035) in the opioid-use group, but these lower scores were due to significantly lower baseline MCS scores in this group. A linear regression analysis did not detect opioid dose-related effects on leg and back pain, disability, and MCS and PCS scores, suggesting that poorer outcomes are not significantly correlated with higher opioid doses taken by the patients. CONCLUSIONS The use of opioid medications to control pain before patients underwent lumbar fusion for degenerative lumbar conditions was associated with less favorable clinical outcomes postoperatively. This is the first study that has demonstrated this association in a homogeneous cohort of patients undergoing TLIF; this association should be studied further to evaluate the conclusions of the present study. Clinical trial registration no.: NCT01406405 ( clinicaltrials.gov ).