STeroids Against Radiculopathy (STAR) trial: a statistical analysis plan

Background Transforaminal epidural injections with steroids (TESI) are used increasingly for patients with sciatica. However, their safety, effectiveness, and cost-effectiveness are still a matter of debate. This a priori statistical analysis plan describes the methodology of the analysis for the STAR trial that assesses the (cost-)effectiveness of TESI during the acute stage of sciatica (< 8 weeks). Methods The STAR trial is a multicentre, randomized controlled, prospective trial (RCT) investigating the (cost-)effectiveness of TESI by making a three-group comparison among patients with acute sciatica due to a herniated lumbar disc (< 8 weeks): (1) TESI combined with levobupivacaine added to oral pain medication (intervention group 1) versus oral pain medication alone (control group), (2) intervention group 1 versus transforaminal epidural injection with levobupivacaine and saline solution added to oral pain medication (intervention group 2), and (3) intervention group 2 versus control group. Co-primary outcomes were physical functioning (Roland Morris Disability Questionnaire), pain intensity (10-point numerical rating scale), and global perceived recovery (7-point Likert scale, dichotomized into ‘recovered’ and ‘not recovered’). For all three comparisons, we defined the following minimal clinically relevant between-group differences: two points for pain intensity (range 0–10), four points for physical functioning (range 0–24) and a 20% difference in recovery rate. Secondary outcomes are health-related quality of life (EQ-5D-5L) and patient satisfaction (7-point Likert scale) and surgery rate. We also collected resource use data to perform an economic evaluation. Analyses will be conducted by intention-to-treat with p < 0.05 (two-tailed) for all three comparisons. Effects will be estimated using mixed models by maximum likelihood. For each comparison, mean differences, or difference in proportions, between groups will be tested per time point and an overall mean difference, or difference in proportions, between groups during the complete duration of follow-up (6 months) will be estimated. In the economic evaluation, Multivariate Imputation by Chained Equations will be used to handle missing data. Cost and effect differences will be estimated using seemingly unrelated regression, and uncertainty will be estimated using bootstrapping techniques. Discussion This statistical analysis plan provides detailed information on the intended analysis of the STAR trial, which aims to deliver evidence about the (cost-)effectiveness of TESI during the acute phase of sciatica (< 8 weeks). Trial registration Dutch National trial register NTR4457 (6 March 2014)

Capsaicin in the Treatment of Refractory Neuropathic Pain after Mastectomy Surgery: A Case Report

A 62-year-old female patient with a history of mastectomy surgery and sentinel lymphadenectomy in the context of breast cancer therapy was referred to our clinic for the treatment of refractory neuropathic pain. She reported a complex set of symptoms including burning and electrical-like sensations as well as profound hyperesthesia, hyperalgesia, and allodynia. The symptoms persisted chronically over months with a strong intensity and did not sufficiently respond to oral pain medication and co-analgetics, that is, tapentadol and pregabalin. As the patient could hardly move her right upper arm due to the pain, the quality of life was greatly reduced. In addition, the patient reported pain-related anxiety and depression. Therefore, a therapy with capsaicin 8% patch was initiated. Treatment with capsaicin 8% led to pain relief without tolerance development and improved flexibility in the affected body area. Despite significant pain relief, previous oral pain medications (tapentadol, pregabalin) as well as the anti-depressant amitriptyline were maintained to fully resolve pain symptoms, anxiety, and depression. In conclusion, capsaicin 8% may represent an effective therapeutic alternative for patients suffering from refractory neuropathic pain.

Multimodal Approach to Acute Pain Management after Nuss Bar Placement and Other Pain Scenarios

Acute pain management can involve regional blocks with local anesthetics, neuraxial blocks such as caudal blocks and epidurals, oral and intravenous opioids, and nonsteroidal anti-inflammatory drugs. Other pain management modalities include neuropathic pain medications, muscle relaxants, antidepressants, acupuncture, techniques for stress relief, and behavioral modification therapy. While there are many options for treating a patient’s pain, the best approach is to understand the symptoms, attempt to determine the cause of the pain, and understand the patient’s goals with regard to treatment. This chapter discusses the multimodal acute pain management for a case of Nuss bar placement, utilizing an epidural, patient-controlled analgesia, and oral pain medication. The chapter has an additional scenario discussing neuraxial analgesia and nerve blocks for a hypospadias repair in an infant. Finally, the third case-based discussion focuses on the treatment of common types of headaches.

A Randomized Single-Blinded Trial of Posttonsillectomy Liposomal Bupivacaine among Adult Patients

Objective To determine whether liposomal bupivacaine (Exparel) is safe and effective in the management of posttonsillectomy pain among adult patients. Study Design A prospective single-blind randomized controlled trial. Setting An academic quaternary care center (Mayo Clinic, Rochester, Minnesota). Subjects and Methods From May 2015 to December 2016, 39 patients were randomized to receive oral pain medication and 8 mL of injected liposomal bupivacaine or oral pain medication alone for treatment of their posttonsillectomy pain. Visual analog scale pain intensity scores, oral pain medication usage, liquid oral intake, and complications were recorded for 2 weeks after the procedure. Results Thirty-nine patients were randomized, with 17 patients in the liposomal bupivacaine group and 22 in the control group. Fifteen patients in the liposomal bupivacaine group and 18 patients in the control group completed the study. Pain intensity score on postoperative day 1 ( P = .043) proved to be the only statistically significant result, with no difference noted in pain scores on postoperative days 2 to 14. There was no difference in pain medication usage, liquid oral intake, postoperative hemorrhage, or adverse events between groups. Conclusions The injection of liposomal bupivacaine in the posttonsillectomy wound bed demonstrates improved pain intensity scores for the first 24 hours after surgery with no adverse complications noted in comparison with patients who did not receive the injection. Given the limited pain reduction and increased cost, use of liposomal bupivacaine in adult tonsillectomy patients appears to have minimal indication for use.