Efficacy and safety of epidural steroid injection following discectomy for patients with lumbar disc herniation: A protocol.
- 作者列表："Cai J","Jiang W","Qiu B","Song Y
BACKGROUND:Concerns exist regarding the analgesia effect and safety of epidural steroid injection (ESI) after discectomy. There is an urgent need of studies that efficiently control for confounding, conduct comprehensive and consecutive observation of potential risks of ESI, and investigate its clinical applicability. We thus further designed a randomized controlled study to assess the efficacy of ESI on postoperative pain and complications in patients undergoing unilateral lumbar microdiscectomy. METHODS:This prospective, blinded randomized controlled trial was conducted at our single hospital. This study was approved by the Committee at the No.2 People's Hospital of Yibin. All procedures were performed by a single surgeon and informed consent was obtained from each patient. Ninty eligible patients diagnosed at our institution with herniated lumbar disc during a period from June 2020 to July 2021 will be assessed. Group 1 was a mixture of 1 mL of 0.5% bupivacaine and 10 mg of triamcinolone acetonide in 1 mL. Group 2 was a mixture of 1 mL of 0.5% bupivacaine and 1 mL of normal saline. The primary outcome measure was the amount of morphine consumption from a patient-controlled analgesia pump at 12, 24, and 48 hours after surgery. The following secondary outcomes were also assessed: postoperative pain score, back pain score, functional disability, and adverse effect. CONCLUSIONS:We hypothesized that the ESI was associated with lower pain score, morphine consumption, and hospital stay, with no significant difference in complications for ESI application after lumbar discectomy in lumbar disc herniation when compared with placebo. TRIAL REGISTRATION:This study protocol was registered in Research Registry (researchregistry5683).
背景: 椎间盘切除术后硬膜外类固醇注射 (ESI) 的镇痛效果和安全性受到关注。迫切需要研究有效控制混杂因素，对ESI的潜在风险进行全面连续的观察，并探讨其临床适用性。因此，我们进一步设计了一项随机对照研究，以评估ESI对单侧腰椎显微椎间盘切除术患者术后疼痛和并发症的疗效。 方法: 本前瞻性、盲法随机对照试验在我院进行。本研究经宜宾市第二人民医院委员会批准。所有手术均由一名外科医生进行，并获得每位患者的知情同意。我们将评估2020年6月至2021年7月期间在我们机构诊断为腰椎间盘突出症的90名符合条件的患者。组1是1毫升的0.5% 布比卡因和10mg的曲安奈德在毫升中的混合物。组2是毫升的0.5% 布比卡因和毫升生理盐水的混合物。主要结局指标是术后12、24和48小时患者自控镇痛泵的吗啡消耗量。还评估了以下次要结局: 术后疼痛评分、背痛评分、功能障碍和不良反应。 结论: 我们假设ESI与较低的疼痛评分、吗啡用量和住院时间相关，与安慰剂相比，ESI在腰椎间盘突出症腰椎间盘切除术后应用的并发症无显著差异。 试验注册: 本研究方案在研究注册中心注册 (researchregistry5683)。
METHODS:BACKGROUND:Maintaining a balance between nociception and analgesia perioperatively reduces morbidity and improves outcomes. Current intraoperative analgesic strategies are based on subjective and nonspecific parameters. The high-frequency heart rate (HR) variability index is purported to assess the balance between nociception and analgesia in patients under general anesthesia. This prospective observational study investigated whether intraoperative changes in the high-frequency HR variability index correlate with clinically relevant nociceptive stimulation and the addition of analgesics. METHODS:Instantaneous and mean high-frequency HR variability indexes were measured continuously in 79 adult subjects undergoing general anesthesia for laparoscopic cholecystectomy. The indexes were compared just before and 2 minutes after direct laryngoscopy, orogastric tube placement, first skin incision, and abdominal insufflation and just before and 6 minutes after the administration of IV hydromorphone. RESULTS:Data from 65 subjects were included in the final analysis. The instantaneous index decreased after skin incision ([SEM], 58.7 [2.0] vs 47.5 [2.0]; P < .001) and abdominal insufflation (54.0 [2.0] vs 46.3 [2.0]; P = .002). There was no change in the instantaneous index after laryngoscopy (47.2 [2.2] vs 40.3 [2.3]; P = .026) and orogastric tube placement (49.8 [2.3] vs 45.4 [2.0]; P = .109). The instantaneous index increased after hydromorphone administration (58.2 [1.9] vs 64.8 [1.8]; P = .003). CONCLUSIONS:In adult subjects under general anesthesia for laparoscopic cholecystectomy, changes in the high-frequency HR variability index reflect alterations in the balance between nociception and analgesia. This index might be used intraoperatively to titrate analgesia for individual patients. Further testing is necessary to determine whether the intraoperative use of the index affects patient outcomes.
METHODS:INTRODUCTION:Chemotherapy-induced peripheral neuropathy (CIPN) is a prominent clinical problem, with limited effective therapies. Preliminary non-randomized clinical trial data support that Scrambler Therapy is helpful in this situation. METHODS:Patients were eligible if they had CIPN symptoms for at least 3 months and CIPN-related tingling or pain at least 4/10 in severity during the week prior to registration. They were randomized to receive Scrambler Therapy versus transcutaneous electrical nerve stimulation (TENS) for 2 weeks. Patient-reported outcomes (PROs) were utilized to measure efficacy and toxicity daily for 2 weeks during therapy and then weekly for 8 additional weeks. RESULTS:This study accrued 50 patients, 25 to each of the 2 study arms; 46 patients were evaluable. There were twice as many Scrambler-treated patients who had at least a 50% documented improvement during the 2 treatment weeks, from their baseline pain, tingling, and numbness scores, when compared with the TENS-treated patients (from 36 to 56% compared with 16-28% for each symptom). Global Impression of Change scores for "neuropathy symptoms," pain, and quality of life were similarly improved during the treatment weeks. Patients in the Scrambler group were more likely than those in the TENS group to recommend their treatment to other patients, during both the 2-week treatment period and the 8-week follow-up period (p < 0.0001). Minimal toxicity was observed. CONCLUSIONS:The results from this pilot trial were positive, supporting the conduct of further investigations regarding the use of Scrambler Therapy for treating CIPN.
METHODS:INTRODUCTION:Enhanced recovery programmes are established as an essential part of laparoscopic colorectal surgery. Optimal pain management is central to the success of an enhanced recovery programme and is acknowledged to be an important patient reported outcome measure. A variety of analgesia strategies are employed in elective laparoscopic colorectal surgery ranging from patient-controlled analgesia to local anaesthetic wound infiltration catheters. However, there is little evidence regarding the optimal analgesia strategy in this cohort of patients. The LapCoGesic study aimed to explore differences in analgesia strategies employed for patients undergoing elective laparoscopic colorectal surgery and to assess whether this variation in practice has an impact on patient-reported and clinical outcomes. MATERIALS AND METHODS:A prospective, multicentre, observational cohort study of consecutive patients undergoing elective laparoscopic colorectal resection was undertaken over a two-month period. The primary outcome measure was postoperative pain scores at 24 hours. Data analysis was conducted using SPSS version 22. RESULTS:A total of 103 patients undergoing elective laparoscopic colorectal surgery were included in the study. Thoracic epidural was used in 4 (3.9%) patients, spinal diamorphine in 56 (54.4%) patients and patient-controlled analgesia in 77 (74.8%) patients. The use of thoracic epidural and spinal diamorphine were associated with lower pain scores on day 1 postoperatively (P < 0.05). The use of patient-controlled analgesia was associated with significantly higher postoperative pain scores and pain severity. DISCUSSION:Postoperative pain is managed in a variable manner in patients undergoing elective colorectal surgery, which has an impact on patient reported outcomes of pain scores and pain severity.