Cryo-Pneumatic Compression Results in a Significant Decrease in Opioid Consumption After Shoulder Surgery: A Multicenter Randomized Controlled Trial.

BACKGROUND: The management of pain after shoulder surgery typically includes the use of cryotherapy and the prescription of opioid analgesics. Much focus has been placed lately on the opioid epidemic, which in part is fueled by excessive prescription of opioid medication. Previous studies have found a combination of cryotherapy and compression effective at reducing analgesic consumption and increasing recovery in patients undergoing knee and spine surgery; however, efficacy in patients undergoing shoulder surgery has not been evaluated. PURPOSE: To evaluate the effectiveness of a cryo-pneumatic compression device on postoperative shoulder pain, narcotic use, and quality of life when compared with standard care cryotherapy. STUDY DESIGN: Randomized controlled trial; Level of evidence, 2. METHODS: In total, 200 patients older than 18 years scheduled for unilateral shoulder surgery were enrolled. Patients were randomized to receive either postoperative cryo-pneumatic compression or standard care. The intervention group received a cryo-pneumatic device, while the standard care group received the treating surgeon's preferred method of postoperative care, including standard cryotherapy. Narcotic use was evaluated by the number of oral morphine milligram equivalents consumed during the postoperative period, as well as the time to cessation of narcotic use. Patient-reported outcome measures consisted of a numeric rating scale pain score, 36-item Short Form Survey, patient experience assessed using the net promoter score, and adverse events. Outcomes were evaluated at 2, 6, and 12 weeks postoperatively. RESULTS: Patients receiving cryo-pneumatic compression reported a significant decrease in opioid consumption when compared with standard care (oral morphine milligram equivalents median, 56.1 vs 112; P = .02468). A significant increase in self-reported function was seen in the cryo-pneumatic compression group at 2 weeks when compared with standard care (mean, 61.2 vs 54.2; P = .0412). CONCLUSION: In patients undergoing unilateral shoulder surgery, the use of cryotherapy with pneumatic compression, when compared with standard care, resulted in significantly decreased opioid consumption as well as increased function at 2 weeks. REGISTRATION: NCT04185064 (ClinicalTrials.gov identifier).

Surgical Management of Headache Disorders - A Systematic Review of the Literature.

PURPOSE OF REVIEW: This review article critically evaluates the latest advances in the surgical treatment of headache disorders. RECENT FINDINGS: Studies have demonstrated the effectiveness of innovative screening tools, such as doppler ultrasound, pain drawings, magnetic resonance neurography, and nerve blocks to help identify candidates for surgery. Machine learning has emerged as a powerful tool to predict surgical outcomes. In addition, advances in surgical techniques, including minimally invasive incisions, fat injections, and novel strategies to treat injured nerves (neuromas) have demonstrated promising results. Lastly, improved patient-reported outcome measures are evolving to provide a framework for comparison of conservative and invasive treatment outcomes. Despite these developments, challenges persist, particularly related to appropriate patient selection, insurance coverage, delays in diagnosis and surgical treatment, and the absence of standardized measures to assess and compare treatment impact. Collaboration between medical/procedural and surgical specialties is required to overcome these obstacles.

Glomerular Filtration Rate Estimation Using ß2-Microglobulin and ß-Trace Protein in Adults With Solid Tumors: A Prospective Cross-Sectional Study.

RATIONALE & OBJECTIVE: ß2-Microglobulin (B2M) and ß-trace protein (BTP) are novel endogenous filtration markers that may improve the accuracy of estimated glomerular filtration rate (eGFR) beyond creatinine and cystatin C (eGFRcr-cys), but they have not been assessed in patients with cancer. STUDY DESIGN: Cross-sectional analysis. SETTING & PARTICIPANTS: Prospective cohort of 1,200 patients with active solid tumors recruited between April 2015 and September 2017. EXPOSURE: CKD-EPI equations without race combining B2M and/or BTP with creatinine with or without cystatin C (2-, 3-, or 4-marker panel eGFR). OUTCOME: Performance of equations compared with eGFRcr-cys and non-GFR determinants of serum B2M and BTP (SB2M, and SBTP, respectively). Measured GFR (mGFR) was determined using the plasma clearance of chromium-51 labeled ethylenediamine tetraacetic acid (51Cr-EDTA). ANALYTICAL APPROACH: Bias was defined as the median of the differences between mGFR and eGFR, and 1-P30 was defined as the percentage of estimates that differed by more than 30% from the mGFR (1-P30). Linear regression was used to assess association of clinical and laboratory variables with SB2M, and SBTP after adjustment for mGFR. RESULTS: Mean age and mGFR were 58.8±13.2 SD years and 78.4±21.7 SD mL/min/1.73m2, respectively. Performance of the 3-marker and 4-marker panel equations was better than eGFRcr-cys (lesser bias and 1-P30). Performance of 2-marker panel equations was as good as eGFRcr-cys (lesser bias and similar 1-P30). SB2M and SBTP were not strongly influenced by cancer site. LIMITATIONS: Participants may have had better clinical performance status than the general population of patients with solid tumors. CONCLUSIONS: B2M and BTP can improve the accuracy of eGFR and may be useful as confirmatory tests in patients with solid tumors, either by inclusion in a multimarker panel equation with creatinine and cystatin C, or by substituting for cystatin C in combination with creatinine. PLAIN-LANGUAGE SUMMARY: The most accurate method to assess estimate kidney function is estimated glomerular filtration rate (eGFR) using creatinine and cystatin C (eGFRcr-cys). We studied whether using ß2-microglobulin (B2M) and/or ß-trace protein (BTP) with creatinine with or without cystatin C (2-, 3-, or 4-marker panel eGFR) might be useful in patients with active solid tumors. The performance of the 3-marker and 4-marker panel equations was better than eGFRcr-cys. Performance of 2-marker panel equations was as good as eGFRcr-cys. We conclude that B2M and BTP can improve the accuracy of eGFR and may be useful as a confirmatory test in patients with solid tumors either by inclusion in multimarker panel equation with creatinine and cystatin C or by substituting for cystatin C in combination with creatinine.

Commentary on 2022 guidelines on clinical trial design in cluster headache and further suggestions.

BACKGROUND: New guidelines for cluster headache clinical trials were recently published. We welcome these new guidelines and raise additional considerations in trial methodologies. MAIN BODY: We present non-inferiority trials to overcome ethical issues with placebo use, and additionally discuss issues with trial recruitment. CONCLUSIONS: We highlight some possible issues and solutions to be considered with the recently published cluster headache trial guidelines.

Refractory occipital neuralgia treatment with nerve decompression surgery: a case series.

Background: The management of refractory occipital neuralgia (ON) can be challenging. Selection criteria for occipital nerve decompression surgery are not well defined in terms of clinical features and best preoperative medical management. Methods: In total, 15 patients diagnosed with ON by a board-certified, fellowship-trained headache specialist and referred to a plastic surgeon for nerve decompression surgery were prospectively enrolled. All subjects received trials of occipital nerve blocks (NB), at least three preventive medications, and onabotulinum toxin (BTX) prior to surgery before referral to a plastic surgeon. Treatment outcomes included headache frequency (headache days/month), intensity (0-10), duration (h), and response to medication/injectable therapies at 12 months postoperatively. Results: Preoperatively, median headache days/month was 30 (20-30), intensity 8 (8-10), and duration 24 h (12-24). Patients trialed 10 (±5.8) NB and 11.7 (±9) BTX cycles. Postoperatively, headache frequency was 5 (0-16) days/month (p < 0.01), intensity was 4 (0-6) (p < 0.01), and duration was 10 (0-24) h (p < 0.01). Median patient-reported percent resolution of ON headaches was 80% (70-85%). All patients reported improvement of comorbid headache disorders, most commonly migraine, and a reduction, discontinuation, or increased effectiveness of medications, NB and BTX. Conclusion: All patients who underwent treatment for refractory ON by a headache specialist and plastic surgeon benefited from nerve decompression surgery in various degrees. The collaborative selection criteria employed in this study may be replicable in clinical practice.

Ibrutinib combination therapy for advanced gastrointestinal and genitourinary tumours: results from a phase 1b/2 study.

BACKGROUND: Ibrutinib, a first-in-class inhibitor of Bruton's tyrosine kinase, is approved for the treatment of various B-cell malignancies and chronic graft-versus-host disease. Based on encouraging preclinical data, safety and efficacy of ibrutinib combined with companion drugs for advanced renal cell carcinoma (RCC), gastric/gastroesophageal junctional adenocarcinoma (GC), and colorectal adenocarcinoma (CRC) were evaluated. METHODS: Ibrutinib 560 mg or 840 mg once daily was administered with standard doses of everolimus for RCC, docetaxel for GC, and cetuximab for CRC. Endpoints included determination of the recommended phase 2 dose (RP2D) of ibrutinib in phase 1b and efficacy (overall response rate [ORR] for GC and CRC; progression-free survival [PFS] for CRC) in phase 2. RESULTS: A total of 39 (RCC), 46 (GC), and 50 (RCC) patients were enrolled and received the RP2D. Safety profiles were consistent with the individual agents used in the study. Confirmed ORRs were 3% (RCC), 21% (GC), and 19% (CRC). Median (90% CI) PFS was 5.6 (3.9-7.5) months in RCC, 4.0 (2.7-4.2) months in GC, and 5.4 (4.1-5.8) months in CRC. CONCLUSIONS: Clinically meaningful increases in efficacy were not observed compared to historical controls; however, the data may warrant further evaluation of ibrutinib combinations in other solid tumours. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02599324.

Treatment Delay From Onset of Occipital Neuralgia Symptoms to Treatment with Nerve Decompression Surgery: A Prospective Cohort Study.

BACKGROUND: The aim of this study was to a) evaluate the time between onset of occipital neuralgia symptoms and nerve decompression surgery, b) perform a cost comparison analysis between surgical and non-surgical treatment of occipital neuralgia and c) report postoperative results of nerve decompression for occipital neuralgia. METHODS: 1,112 subjects who underwent screening for nerve decompression surgery were evaluated for occipital neuralgia. 367 (33%) patients met the inclusion criteria. Timing of occipital neuralgia symptom onset and pain characteristics were prospectively collected. Cost associated with the non-surgical treatment of occipital neuralgia was calculated for the period between onset of symptoms and surgery. RESULTS: 226 (73%) patients underwent occipital nerve decompression. The average time between onset of occipital neuralgia and surgery was 19 years (7.1-32). Postoperatively, the median number of pain days per month decreased by 17 (0-26, 57%) (p < 0.001), the median pain intensity decreased by 4 (2-8, 44%) (p < 0.001), and median pain duration in hours was reduced by 12 (2-23, 50%) (p < 0.001). The annual mean cost of non-surgical occipital neuralgia treatment was $28,728.82 ($16,419.42-$41,198.41) per patient. The mean cost during the 19-year timeframe prior to surgery was $545,847.75($311,968.90-$782,769.82). CONCLUSION: This study demonstrates that patients suffer from occipital neuralgia for an average of 19 years prior to undergoing surgery. Nerve decompression reduces symptom severity significantly and should be considered earlier in the treatment course of occipital neuralgia that is refractory to conservative treatment to prevent patient morbidity and decrease direct and indirect healthcare costs. IRB REGISTRATION NUMBER & NAME: Weill Cornell Medicine: 23-04025985, Prospective Cohort Study Investigating Long- Term Outcomes After Headache Surgery.The Massachusetts General Hospital: 2012P001527, Correlation of pre-operative pain self-efficacy and post-operative migraine-specific symptoms and disability.

CT guided injection of 99mTc-MAA for lung nodule localization prior to VATS.

AIM: CT guided technetium99m-macroaggregated albumin (99mTc-MAA) injection for lung nodule localization prior to video-assisted thoracoscopic surgery (VATS) is employed at our institution for more than a decade. We retrospectively studied the success rate, factors that affect outcomes, and complications of this procedure. MATERIALS AND METHODS: 147 patients with 164 nodules underwent this procedure before VATS. Imaging and procedure characteristics, complications of the procedure, successful intra-operative localization and wedge resection, if there was conversion of primary VATS to open thoracotomy and if so the reason, and histopathological diagnosis for each nodule were reviewed by two radiologists in consensus. In case of unsuccessful wedge resection, reasons for failure were derived from electronic medical record. The impact of nodule and procedure characteristics on successful intra-operative localization was assessed. RESULTS: Excluding 9 nodules with unsuccessful localization due to non-procedure related reasons, the CT guided procedure was successful in 96.1% for intraoperative localization (149/155). Pleural leak of the radiotracer, split injection within the lobe, injection into a wrong nodule and gamma probe malfunction were primary reasons for failure. Nodule size, depth from pleura, and time between radiotracer injection and surgical incision did not impact success of the procedure. Among the 6 cases with procedure related failure, only 1 required conversion to open thoracotomy. CONCLUSION: CT guided 99mTc-MAA injection for intra-operative lung nodule localization is a feasible procedure with a high success rate and low complication rate. Attention to technique can potentially avoid procedure failure.