Background: The use of spinal cord stimulation (SCS) for managing severe refractory chronic pain has expanded considerably due to positive statistical evidence regarding its use; however, the statistical robustness of the underlying randomized controlled trials (RCTs) requires further scrutiny. One such tool that can be used for this purpose is the fragility index, which quantifies how many individual outcome events must be altered for an outcome to lose statistical significance. Thus the index can be used quantitatively to assess the stability and robustness of an RCT’s conclusions, with higher values indicating increased trial stability. This study assesses the fragility of pain outcomes across RCTs investigating SCS for chronic pain to better understand the quality and robustness of evidence. Methods: A systematic search was conducted for RCTs assessing SCS for any chronic pain indication. The primary outcome was an evaluation of the trial-specific fragility index for the prespecified pain primary outcomes of RCTs. Secondary outcomes included an evaluation of fragility for (1) specified indications for SCS therapy, (2) reported pain outcomes appearing in three or more RCTs, (3) the presence/absence of a conflict of interest, and (4) comparisons of SCS to conservative management or different SCS waveform modalities. Results: A total of 30 RCTs were included. The median (interquartile range [IQR]) fragility index across the primary outcome of all trials was 5.45 (3.00 to 11.45). There was no statistical difference between the (1) types of outcomes (dichotomous vs. continuous; P = 0.710), (2) primary versus secondary pain outcomes ( P = 0.771), or (3) presence versus absence of trial conflict of interest ( P = 0.753). Indications with a median (IQR) fragility score greater than three included persistent spinal pain syndrome type 2 with a score of 8.00 (2.80 to 12.60), painful diabetic neuropathy with a score of 6.00 (3.00 to 11.80), complex regional pain syndrome with a score of 7.20 (4.62 to 81.50), mixed etiologies with a score of 9.00 (3.00 to 38.00), and other etiologies with a score of 3.00 (1.00 to 8.55). Conclusions: This study suggests that the majority of RCTs investigating primary pain outcomes after SCS therapy are robust with relatively high fragility scores. Reporting the fragility of outcomes in trials can provide a more comprehensive assessment of trial robustness and can further aid clinicians in interpreting trial results and making informed treatment decisions.
Analgesic Benefits of Motor-sparing Fascial Plane Blocks in Comparison to Periarticular Local Infiltration Analgesia for Total Hip Arthroplasty: A Network Meta-analysis
Background: Periarticular local infiltration analgesia has become an important mainstay of multimodal analgesia after elective total hip arthroplasty (THA). However, the role of novel motor-sparing fascial plane blocks—with or without periarticular local infiltration analgesia—has not been fully elucidated for patients undergoing THA. The authors conducted a network meta-analysis evaluating the relative analgesic effectiveness of motor-sparing fascial plane blocks (quadratus lumborum, erector spinae, and pericapsular nerve group blocks) and periarticular local infiltration analgesia for adult patients undergoing THA. Methods: Randomized trials examining single-injection quadratus lumborum, erector spinae, or pericapsular nerve group blocks, or periarticular local infiltration analgesia, for THA were sought. The primary outcome was area under the curve (AUC) rest pain scores during the period from 0 to 24 h. Secondary outcomes included rest pain scores at 0, 6, 12, and 24 h; postoperative function at 6, 12, and 24 h; analgesic consumption at 0 to 24 h; incidence of opioid-related side effects; and incidence of block-related complications. Network meta-analysis was performed using a frequentist approach. Results: A total of 44 trials (3,579 patients) evaluating the quadratus lumborum block, erector spinae block, pericapsular nerve group block, or periarticular local infiltration analgesia for THA were considered. Network meta-analysis was used to derive the probability of each intervention being the most effective as compared to the others (P score). For AUC 0 to 24 h rest pain, periarticular local infiltration analgesia was the most effective intervention, as demonstrated by a P score of 89%. For postoperative analgesic consumption, the quadratus lumborum block was the most effective intervention, with a P score of 88%. This was followed by the pericapsular nerve group block (74%), the erector spinae block (38%), and periarticular local infiltration analgesia (42%). Conclusions: Periarticular local infiltration analgesia alone provides the most consistent improvements in postoperative rest pain, analgesic consumption, and functional recovery after THA. The addition of a quadratus lumborum block or pericapsular nerve group block to periarticular local infiltration may further improve analgesic outcomes.
Exploring the Additive or Synergistic Effects of the Systemic and Perineural Routes of Dexamethasone as Adjuncts to Supraclavicular Block: A Randomized Controlled Trial
Background: Both perineural and intravenous dexamethasone have been proposed as effective adjuncts that prolong the duration of peripheral nerve blocks. The authors sought to explore whether combining systemic with perineural dexamethasone yields any additive or synergistic effect on the characteristics and analgesic effects of peripheral nerve blocks. Methods: Adult patients having distal radius open reduction and internal fixation and/or carpometacarpal arthroplasty under supraclavicular block were randomized to intravenous dexamethasone, a combination of perineural plus intravenous dexamethasone, or no dexamethasone (control). Sensory block duration was set as the primary outcome. Secondary outcomes included motor block duration; postoperative rebound pain scores as well as worst pain at 8, 16, 24, 32, 40, and 48 h; opioid consumption at 0 to 24 and 25 to 48 h; incidence of nausea/vomiting; and presence of burning sensation in the blocked limb at 24 and 48 h. The null hypothesis was lack of difference in sensory block duration between the three groups. Results: A total of 104 patients were included in the analysis (intravenous dexamethasone, 37; intravenous plus perineural dexamethasone, 34; control, 33). Compared to intravenous dexamethasone alone, adding perineural dexamethasone did not yield any incremental benefits in any of the outcomes examined. The mean ± SD of sensory block duration was 21.3 ± 7.3 h in the intravenous dexamethasone group, 20.6 ± 6.1 h in the perineural plus intravenous group, and 16.8 ± 6.8 h in the control group. The mean difference (95% CI) of sensory block duration was significantly prolonged by 4.5 h (95% CI, 1.3 to 7.7; P = 0.006) in the intravenous dexamethasone group and 3.8 h (95% CI, 0.8 to 6.8; P = 0.015) in the perineural plus intravenous dexamethasone group compared to control; however, no difference was observed when the two dexamethasone groups were compared to each other (0.7 h [95% CI, –2.5 to 3.9]; P = 0.670). Compared to control, both intravenous and intravenous plus perineural dexamethasone similarly reduced 24-h pain scores and opioid consumption and decreased incidence of rebound pain. Conclusions: The authors’ findings suggest that intravenous dexamethasone alone is sufficient to improve analgesic outcomes for patients receiving supraclavicular block for upper extremity surgery. Combining the intravenous and perineural dexamethasone routes does not yield an additive or synergistic effect on the characteristics and analgesic effects of supraclavicular block.
Incidence of subsequent surgical decompression following minimally invasive approaches to treat lumbar spinal stenosis: A retrospective review
Abstract Background Context Surgical decompression is the definitive treatment for managing symptomatic lumbar spinal stenosis; however, select patients are poor surgical candidates. Consequently, minimally invasive procedures have gained popularity, but there exists the potential for failure of therapy necessitating eventual surgical decompression. Purpose To evaluate the incidence and characteristics of patients who require surgical decompression following minimally invasive procedures to treat lumbar spinal stenosis. Study Design/Setting Retrospective review. Patient Sample Patients who underwent minimally invasive procedures for lumbar spinal stenosis (Percutaneous Image‐guided Lumbar Decompression [PILD] or interspinous spacer device [ISD]) and progressed to subsequent surgical decompression within 5 years. Outcome Measures The primary outcome was the rate of surgical decompression within 5 years following the minimally invasive approach. Secondary outcomes included demographic and comorbid factors associated with increased odds of requiring subsequent surgery. Methods Patient data were collected using the PearlDiver‐Mariner database. The rate of subsequent decompression was described as a percentage while univariable and multivariable regression analysis was used for the analysis of predictors. Results A total of 5278 patients were included, of which 3222 (61.04%) underwent PILD, 1959 (37.12%) underwent ISD placement, and 97 (1.84%) had claims for both procedures. Overall, the incidence of subsequent surgical decompression within 5 years was 6.56% (346 of 5278 patients). Variables associated with a significantly greater odds ratio (OR) [95% confidence interval (CI)] of requiring subsequent surgical decompression included male gender and a prior history of surgical decompression by 1.42 ([1.14, 1.77], p = 0.002) and 2.10 times ([1.39, 3.17], p < 0.001), respectively. In contrast, age 65 years and above, a diagnosis of obesity, and a Charlson Comorbidity Index score of three or greater were associated with a significantly reduced OR [95% CI] by 0.64 ([0.50, 0.81], p < 0.001), 0.62 ([0.48, 0.81], p < 0.001), and 0.71 times ([0.56, 0.91], p = 0.007), respectively. Conclusions Minimally invasive procedures may provide an additional option to treat symptomatic lumbar spinal stenosis in patients who are poor surgical candidates or who do not desire open decompression; however, there still exists a subset of patients who will require subsequent surgical decompression. Factors such as gender and prior surgical decompression increase the likelihood of subsequent surgery, while older age, obesity, and a higher Charlson Comorbidity Index score reduce it. These findings aid in selecting suitable surgical candidates for better outcomes in the elderly population with lumbar spinal stenosis.