Intravenous lidocaine suppresses fentanyl-induced coughing: a double-blind, prospective, randomized placebo-controlled study

IV lidocaine is effective in suppressing the cough reflex of tracheal intubation, extubation, bronchography, bronchoscopy, and laryngoscopy. We investigated this effect of lidocaine on fentanyl-induced cough in 502 patients of ASA physical status I and II scheduled for elective surgery. The patients were assigned to 2 equal groups to receive either lidocaine 1.5 mg/kg or placebo (0.9% saline) over 5 s 1 min before the administration of fentanyl 3 mug/kg in a randomized and double-blind fashion. Coughs were classified as coughing and graded as mild (1-2), moderate (3-4), or severe (5 or more). The results of the study suggest that IV lidocaine 1.5 mg/kg, when administered 1 min before fentanyl, is significantly effective in suppressing fentanyl-induced cough compared to placebo (0.9% saline) (218 versus 165 patients) (P < 0.002) but without affecting the severity of cough (P > 0.05).     

Cefamandole in gastroduodenal surgery: a controlled, prospective, randomized, double-blind study

Acceptance of the value of antibiotic prophylaxis in gastroduodenal surgery is growing, but only one controlled, double-blind study justifying this is available. In this second, controlled, randomized, double-blind study 60 patients underwent urgent and elective gastroduodenal operations. Among 32 patients receiving cefamandole perioperatively for prophylaxis, only 1 subsequently had a wound infection, but wound infections occurred in 8 of the 28 patients who received a placebo (P less than 0.01). Infection rates were higher in contaminated wounds and in urgent operations than in clean-contaminated wounds and elective surgery. The results confirm the value of antibiotic prophylaxis in this setting.     

Intravenous lidocaine, amantadine, and placebo in the treatment of sciatica: a double-blind, randomized, controlled study

BACKGROUND AND OBJECTIVES: Sciatica is a neuropathic pain syndrome caused by compression and/or inflammation of spinal nerve roots by herniated disc material, and its treatment is therefore usually aimed at reducing compression and inflammation. Studies have shown that both systemic local anesthetics and N-methyl-D-aspartate (NMDA) receptor antagonists may produce analgesia in a variety of neuropathic pain syndromes. The present study evaluated the analgesic efficacy of i.v. infusions of the local anesthetic lidocaine, the NMDA receptor antagonist amantadine, and a placebo in sciatica. METHODS: Thirty patients with sciatica, as confirmed by physical examination and imaging studies, were enrolled in a randomized, double-blind, three-arm crossover trial. Infusions of amantadine (2.5 mg/kg), lidocaine (5 mg/kg), and a placebo were administered over a 2-hour period, 2-7 days apart from each other. Spontaneous pain (visual analog scale) and evoked pain (straight leg raise) were measured every 30 minutes for 3 hours. RESULTS: Lidocaine reduced spontaneous pain as compared with amantadine and with the placebo for all measurements and at a significant level at the 30 (P < .05), 120, and 180 (P < .01) minute time points. Maximal pain reduction from the baseline was 62 +/- 7% for lidocaine, 43 +/- 7% for amantadine, and 47 +/- 7% for the placebo. Straight leg raise test also significantly improved with lidocaine (from 30 to 37 degrees; P < .05), as compared to amantadine (34-36 degrees) and to the placebo (32-34 degrees). All three treatments were relatively well tolerated. CONCLUSIONS: Intravenous lidocaine, rather than amantadine, reduces both spontaneous and evoked sciatic pain.     

厚朴排气合剂对开腹胃肠道手术后胃肠功能恢复影响的多中心前瞻性研究

目的 评价中成药厚朴排气合剂对开腹胃肠道手术后患者胃肠功能恢复的有效性及安全性.方法 采用多中心前瞻性随机双盲对照方法,分析2010年10月至2011年9月3家临床研究中心纳入开腹胃肠道手术患者144例(北京大学人民医院胃肠外科66例、首都医科大学附属北京友谊医院普通外科72例、广东省人民医院普通外科6例)的临床资料,根据Ⅲ期临床试验结果以2∶1按随机数字表法将入组患者分为两组,试验组96例,对照组48例,入组后均接受治疗.其中5例患者因不符合本研究标准而剔除,共有139例患者纳入研究,其中试验组92例,对照组47例.本研究经各研究中心伦理委员会审核批准,患者签署知情同意书.两组患者于术后16 h及20 h分别经胃管给予厚朴排气合剂50 ml(试验组)或厚朴排气合剂模拟剂50 ml(对照组),术后进行常规外科治疗,待肛门排气后拔除胃管开始饮水,并逐步进食肠内营养液或流质饮食.两组患者采用统一的静脉镇痛方案.研究期间禁止使用增强或抑制胃肠动力药物.术后记录患者肠鸣音恢复时间、首次肛门排气时间、首次排便时间、首次进食固体食物时间.手术前、给药后每天记录患者生命体征.术后第6天进行血、尿常规,肝、肾功能,心电图检查,并记录药物不良事件.上述时间计算方法均为出现时间与手术结束时间的时间差值.采用Kaplan-Meier法,计算四分位数(Q1、Q2、Q3)手术后各指标出现时间及各时点出现率,并绘制Kaplan-Meier估计曲线,对两组患者的时间分布采用Log-rank检验.计量资料采用t检验或秩和检验,计数资料列出频数和百分数,采用x2检验或Fisher确切概率法.结果 试验组和对照组患者术后中位肠鸣音恢复时间分别为21.4(20.0,23.7)h和47.5(44.0,56.5)h,中位首次肛门排气时间分别为45.0(40.0,54.0)h和91.0(87.0,93.8)h,中位术后首次排便时间分别为65.5(54.7,74.0)h和98.0(94.0,113.5)h,两组比较,差异有统计学意义(Log-rank值分别为21.67,53.15,11.81,P＜0.05).试验组和对照组中位首次进食固体食物时间分别为72.5(66.2,110.5)h和116.3(114.8,117.3)h,但差异无统计学意义(Log-rank值为13.70,P＞0.05).两组患者用药前后体温、呼吸、心率、收缩压、舒张压等生命体征的变化比较,差异无统计学意义(Z=0.03,0.68,0.97,0.22,0.72,P＞0.05);用药后血、尿常规,肝、肾功能,心电图异常患者例数比较,差异无统计学意义(P＞0.05).两组患者均无机械性肠梗阻和吻合口漏等严重药物不良事件发生.结论 厚朴排气合剂可促进开腹胃肠道手术后患者胃肠功能恢复,临床使用安全、有效.     

Perioperative erythropoietin administration in patients with gastrointestinal tract cancer: prospective randomized double-blind study

OBJECTIVE: To investigate the effect of recombinant human erythropoietin (r-HuEPO) administration on perioperative hemoglobin concentrations and on the number of blood transfusions in patients undergoing surgery for gastrointestinal tract malignancies. SUMMARY BACKGROUND DATA: Erythropoietin has been shown to improve the yield of autologously predonated blood and to reduce the subsequent requirements for homologous blood transfusions in cancer patients. METHODS: In this double-blind placebo-controlled study, 31 cancer patients received subcutaneous r-HuEPO in a dose of 300 IU/kg body weight plus 100 mg iron intravenously (study group) and 32 patients received placebo medication and iron (control group). All patients received the medications daily for at least 7 days before and 7 days after the operation. RESULTS: Patients who received erythropoietin received significantly fewer transfusions intraoperatively and postoperatively. Postoperatively, the study group had significantly higher hematocrit, hemoglobin, and reticulocyte count values compared to the control group. The use of erythropoietin was also associated with a reduced number of postoperative complications and improved 1-year survival. CONCLUSIONS: Patients with gastrointestinal tract cancer and mild anemia benefit from perioperative erythropoietin administration in terms of stimulated erythropoiesis, reduction in the number of blood transfusions, and a favorable outcome.     

Tranexamic acid administration after cardiac surgery: a prospective, randomized, double-blind, placebo-controlled study

BACKGROUND: Many different doses and administration schemes have been proposed for the use of the antifibrinolytic drug tranexamic acid during cardiac surgery. This study evaluated the effects of the treatment using tranexamic acid during the intraoperative period only and compared the results with the effects of the treatment continued into the postoperative period. METHODS: Patients undergoing elective cardiac surgery with use of cardiopulmonary bypass (N = 510) were treated intraoperatively with tranexamic acid and then were randomized in a double-blind fashion to one of three postoperative treatment groups: group A: 169 patients, infusion of saline for 12 h; group B: 171 patients, infusion of tranexamic acid, 1 mg x kg(-1) x h(-1) for 12 h; group C: 170 patients, infusion of tranexamic acid, 2 mg x kg(-1) x h(-1) for 12 h. Bleeding was considered to be a primary outcome variable. Hematologic data, allogeneic transfusions, thrombotic complications, intubation time, and intensive care unit and hospital stay duration also were evaluated. RESULTS: No differences were found among groups regarding postoperative bleeding and outcomes; however, the group treated with 1 mg x kg(-1) x h(-1) tranexamic acid required more units of packed red blood cells because of a significantly lower basal value of hematocrit, as shown by multivariate analysis. CONCLUSIONS: Prolongation of treatment with tranexamic acid after cardiac surgery is not advantageous with respect to intraoperative administration alone in reducing bleeding and number of allogeneic transfusions. Although the prevalence of postoperative complications was similar among groups, there is an increased risk of procoagulant response because of antifibrinolytic treatment. Therefore, the use of tranexamic acid during the postoperative period should be limited to patients with excessive bleeding as a result of primary fibrinolysis.     

Tenoxicam and paracetamol-codeine combination after oral surgery: a prospective, randomized, double-blind, placebo-controlled study

We studied 90 adults undergoing surgical removal of at least both lower third molar teeth as day cases under standardized general anaesthesia. Patients were allocated randomly (with stratification for surgeon) to receive tenoxicam 40 mg, tenoxicam 20 mg or placebo i.v. at induction of anaesthesia and orally (effervescent tablets) with food on each of the subsequent 2 days. Panadeine (paracetamol 500 mg-codeine 8 mg) was given before operation and was available as needed for pain thereafter, to a limit of two tablets every 4 h. Nefopam i.v. was also available. Efficacy variables and adverse reactions were assessed over 6 days. Over the 6-day period, patients who received tenoxicam reported less pain on rest (area under the curve; P < 0.05) and less disturbance in sleep (P < 0.01) even though they used fewer Panadeine tablets (P < 0.05). Differences between tenoxicam 40 mg and 20 mg were not significant. There was no significant difference in nefopam requirements or side effects, and no adverse event attributable to the study medication.      

Total parenteral nutrition with glutamine dipeptide after major abdominal surgery: a randomized, double-blind, controlled study.

OBJECTIVE: To assess the efficacy of glutamine (Gln) dipeptide-enriched total parenteral nutrition (TPN) on selected metabolic, immunologic, and clinical variables in surgical patients. SUMMARY BACKGROUND DATA: Depletion of Gln stores might lead to severe clinical complications. Recent studies indicate that the parenteral provision of Gln or Gln-containing dipeptides improves nitrogen balance, maintains the intracellular Gln pool, preserves intestinal permeability and absorption, and shortens hospital stay. METHODS: Twenty-eight patients (age range, 42-86 years, mean 68 years) undergoing elective abdominal surgery were allocated, after randomization, to two groups to receive isonitrogenous (0.24 g nitrogen kg(-1) day(-1)) and isoenergetic (29 kcal/122 kJ kg(-1) day(-1)) TPN over 5 days. Controls received 1.5 g of amino acids kg(-1) day(-1), and the test group received 1.2 g of amino acids and 0.3 g of L-alanyl-L-glutamine (Ala-Gln) kg(-1) day(-1). Venous heparinized blood samples were obtained before surgery and on days 1, 3, and 6 after surgery for routine clinical chemistry and for the measurement of plasma free amino acids. Lymphocytes were counted and the generation of cysteinyl-leukotrienes from polymorphonuclear neutrophil granulocytes was analyzed before surgery and on days 1 and 6 after surgery. Nitrogen balances were calculated postoperatively on days 2, 3, 4, and 5. RESULTS: No side effects or complaints were noted. Patients receiving Gln dipeptide revealed improved nitrogen balances (cumulative balance over 5 days: -7.9 +/- 3.6 vs. -23.0 +/- 2.6 g nitrogen), improved lymphocyte recovery on day 6 (2.41 +/- 0.27 vs. 1.52 +/- 0.17 lymphocytes/nL) and improved generation of cysteinyl-leukotrienes from polymorphonuclear neutrophil granulocytes (25.7 +/- 4.89 vs. 5.03 +/- 3.11 ng/mL). Postoperative hospital stay was 6.2 days shorter in the dipeptide-supplemented group. CONCLUSION: We confirm the beneficial effects of Gln dipeptide-supplemented TPN on nitrogen economy, maintenance of plasma Gln concentration, lymphocyte recovery, cysteinyl-leukotriene generation, and shortened hospital stay in surgical patients.     

Intraperitoneal and intravenous lidocaine for effective pain relief after laparoscopic appendectomy: a prospective, randomized, double-blind, placebo-controlled study

Background  

The preemptive intravenous and intraperitoneal application of local anesthetics is known to improve the postoperative outcome in abdominal surgery. The aim of this study was to compare the analgesic effect of intravenous lidocaine injection to that of intraperitoneal lidocaine instillation in patients who were undergoing laparoscopic appendectomy (LA).     

Effect of narcotic pretreatment on pain after rocuronium injection: a randomized,double-blind controlled comparison with lidocaine

Various strategies have been studied to reduce the discomfort of rocuronium pain. These studies have shown fentanyl and lidocaine to be effective in reducing the incidence of pain on rocuronium injection. This prospective, randomized, and double-blind study was carried out on 80 neurosurgical patients for whom pain on rocuronium injection was assessed after pretreatment with lidocaine, fentanyl, sufentanil, or normal saline. The 80 neurosurgical patients were randomly allocated to anyone of the groups to receive lidocaine, fentanyl, sufentanil, or normal saline prior to being given rocuronium. The patients were asked about any discomfort in the hand, and also to rank that discomfort on a 5-point scale. In the normal saline group, the incidence of pain was 95%, of which 90% had very severe pain. In the lidocaine group, only 10% of patients reported pain, which was mild in nature. In the fentanyl group, 95% of patients had pain, of whom 25% had severe to very severe pain. In the sufentanil group, 85% of patients reported pain, of whom 25% fell into the severe to very severe group. We found that lidocaine was best at decreasing the incidence of pain on intravenous (i.v.) injection of rocuronium. Although the incidence of pain on injection of rocuronium with both fentanyl and sufentanil was high, the intensity was definitely reduced, with most patients falling in the mild pain group.     

不同剂量舒芬太尼复合靶控输注异丙酚麻醉诱导对患者血液动力学的影响前瞻性、多中心、随机、双盲研究

目的 评价不同剂量舒芬太尼复合靶控输注异丙酚麻醉诱导对患者血液动力学的影响,探讨复合异丙酚时舒芬太尼的适宜麻醉诱导剂量.方法 本试验为前瞻性、多中心、随机、双盲的临床研究.拟行腹部手术患者165例,ASA Ⅰ或Ⅱ级,年龄18～63岁,性别不限,体重42～90 kg,根据舒芬太尼不同麻醉诱导剂量分为4组:舒芬太尼0.4 μg/kg组(S1组,n=44)、0.6 μg/kg组(S2组,n=43)、0.8 μg/kg组(S3组,n=38)、1 μg/kg组(S4组,n=40).麻醉诱导:静脉注射咪达唑仑0.05 mg/kg,靶控输注异丙酚,血浆靶浓度3.0 μg/ml,当BIS<60且异丙酚达设定血浆靶浓度时,各组经30 s分别静脉注射舒芬太尼0.4、0.6、0.8、1 μg/kg,四组均静脉注射罗库溴铵0.9 mg/kg,静脉注射舒芬太尼后3 min(BIS 35～45)行气管插管、机械通气.于麻醉诱导前(T0)、异丙酚血浆靶浓度3.0 μg/ml时(T1)、静脉注射舒芬太尼后1 min(T2)、3 min(T3)、气管插管后即刻(T4)、1 min(T5)、3 min(T6)、5 min(T7)时记录SP、DP、MAP和HR.记录心血管不良事件和气管插管反应的发生情况.结果 四组麻醉诱导期间低血压、高血压和心动过速的发生率比较差异无统计学意义(P>0.05),T4-7时S4组心动过缓发生率较其余各组升高(P<0.05);S1组和S2组气管插管反应发生率较S3组和S4组升高(P<0.05或0.01).结论 舒芬太尼0.8 μg/kg复合靶控输注异丙酚(血浆靶浓度3.0 μg/ml)麻醉诱导时患者血液动力学平稳,是复合异丙酚时舒芬太尼适宜的麻醉诱导剂量.     

Topical nifedipine with lidocaine ointment versus active control for pain after hemorrhoidectomy: results of a multicentre,prospective, randomized,double-blind study

Background

Spasm through the internal anal sphincter is one of the supposed causes for pain after hemorrhoidectomy, a common and distressing experience. We hypothesized that the addition of topical nifedipine to lidocaine would improve pain control by causing a relaxation of the smooth muscle of the internal anal sphincter.

Methods

We conducted a multicentre randomized, double-blind trial to compare the efficacy of 0.3% nifedipine and 1.5% lidocaine ointment versus 1.5% lidocaine ointment alone in reducing pain after hemorrhoidectomy. A physician unaware of the treatment arm measured pain by use of the Analogue Chromatic Continuous Scale (ACCS) at baseline; soon after surgery; at 2, 4, 6, 8 and 24 hours after surgery; on day 7 after surgery; and at a final visit 14 days after surgery. The physician also noted the time to first analgesic administration within 24 hours after surgery.

Results

In all, 135 patients per group participated (270 total). Evaluation of the delta ACCS score versus basal value, a covariate for rescue analgesic administration time, revealed better pain control in the group that received nifedipine with lidocaine at 6 hours after surgery and on day 7 (p < 0.011 and p < 0.054, respectively). We noticed no difference between groups for time of administration of rescue analgesic, blood pressure, heart rate or frequency of headache.

Conclusion

Although there was no difference between groups for time of administration of rescue analgesic after open hemorrhoidectomy, the patients’ assessment of pain using ACCS showed that the use of topical nifedipine with lidocaine may provide a slight significant difference in favour of the study group at 6 hours and at day 7 after surgery. Narcotic analgesics and nonsteroidal anti-inflammatory drug administration should continue to be recommended. Further research focusing on these outcomes is warranted.     

Intraoperative systemic lidocaine for pre-emptive analgesics in subtotal gastrectomy: a prospective,randomized, double-blind,placebo-controlled study

Background

Pre-emptive intravenous lidocaine infusion is known to improve postoperative pain in abdominal surgery. We assessed the effect of intravenous lidocaine infusion in patients who underwent subtotal gastrectomy.

Methods

We conducted a double-blind, placebo-controlled study with patients undergoing subtotal gastrectomy for early gastric cancer divided into 2 groups: 1 group received intravenous lidocaine infusion preoperatively and throughout surgery, and the other received normal saline infusion (placebo). We assessed postoperative outcomes, including pain scores on a visual analogue scale (VAS), administration frequency of patient-controlled analgesia (PCA) and the amount of consumed fentanyl. Postoperative nausea and vomiting, length of hospital stay (LOS), time to return to regular diet and patient satisfaction at discharge were evaluated.

Results

There were 36 patients in our study. Demographic characteristics were similar between the groups. The VAS pain scores and administration frequency of PCA were significantly lower in the lidocaine group until 24 hours after surgery, and fentanyl consumption was significantly lower in this group until 12 hours postoperatively compared with the placebo group. The total amount of consumed fentanyl and the total administration frequency of PCA were significantly lower in the lidocaine than the control group. No significant differences were detected in terms of nausea and vomiting, return to regular diet, LOS and patient satisfaction, and there were no reported side-effects of lidocaine.

Conclusion

Intravenous lidocaine infusion reduces pain during the postoperative period after subtotal gastrectomy.     

Intravenous regional bretylium and lidocaine for treatment of reflex sympathetic dystrophy: a randomized, double-blind study.

Patients with reflex sympathetic dystrophy, who received transient pain relief from stellate ganglion blocks or lumbar sympathetic blocks and had abnormal isolated cold stress tests, were enrolled in a study to determine the efficacy of intravenous regional bretylium. Each patient received two control treatments (0.5% lidocaine) and two treatments with 0.5% lidocaine and bretylium 1.5 mg/kg in a randomized, double-blind fashion. A standard intravenous regional technique was used with a 300-mm Hg tourniquet pressure for 20 min. Patients kept a daily record of pain relief (0 = no relief, 100% = complete relief). A decrease in pain of more than 30% was considered clinically significant. Therefore, once the patient's pain relief was less than 30%, the next intravenous regional treatment was performed. Bretylium and lidocaine provided more than 30% pain relief for a mean of 20.0 (+/- 17.5) days, whereas lidocaine alone provided relief for only 2.7 (+/- 3.7) days (Mann-Whitney U-test, P less than 0.001). A mean temperature increase in the treated limb of +2.64 +/- 3.41 degrees C above the baseline temperature was noted after bretylium administration, whereas after control treatments the change was -0.086 +/- 1.30 degrees C (Mann-Whitney U-test, P less than 0.02). We conclude that the combination of bretylium and lidocaine is significantly more effective than lidocaine alone when an intravenous block is used to treat reflex sympathetic dystrophy.