Lidocaine Combined With Low Opioid Anesthesia and Analgesia in Patients With Primary Liver Cancer
キーワード
概要
説明
200 patients with primary liver cancer who meet the standard are included. According to the random number, the patients are divided into lidocaine group and conventional analgesia group. Changes in liver and kidney function, blood routine, blood coagulation function and tumor marker alpha-fetoprotein(AFP) are collected before surgery. Preoperative CT reports on liver mass size, location, relationship with surrounding tissues, hepatitis related virus titer and preoperative medication are recorded.
General anesthesia induction in the conventional group: midazolam 2mg, propofol 1.5-2.5mg/kg, sufentanil 0.2-0.3ug/kg, cisatracurium 0.2mg/kg, 50mg flurbiprofen injection or 40mg parecoxib sodium injection(exclude use contraindications). During the operation, propofol, desflurane or sevoflurane are maintained. Intraoperative analgesia: nitrous oxide, compound remifentanil 0.1-0.2ug/kg.min, remifentanil 50-150ug or sufentanil 0.1ug/kg for the necessary time. At the end of the operation: the incision is locally infiltrated with 0.5% ropivacaine (20ml) and dexmedetomidine (1ug/kg). If the operation time is longer than 5 hours, the patient should be re-injected with 40mg parecoxib sodium injection, and connect with the patient-controlled intravenous analgesia(PCIA) that drug formula is sufentanil 2ug/kg, dexmedetomidine 200ug and granisetron 12mg until postoperation 3 days. In the lidocaine group, general anesthesia is induced by slow intravenous lidocaine at 1.5mg/kg, followed by continuous injection of lidocaine at 2mg/kg.h with micropump and other anesthesia induction is maintained as the conventional group. At the end of the operation, the PCIA with lidocaine is used with a dose of 30mg/kg(no more than 2000mg at most), and the other formula is the same as that of the conventional group. In patients with contraindications to NSAIDs drug use, dezocine 5mg or hydromorphone 2mg should be given intravenously 30 minutes before the end of surgery. The plasma concentration of lidocaine is measured immediately postoperation and within the postoperative first 24 hours. Natural killer cells, cytokines l-6, TNF-a and C-reactive protein in peripheral blood at postoperative 24h. Changes of liver and kidney function indexes at postoperative 24 hours .
Visual analogue scale (VAS) is used to evaluate pain at resting state and light activities at postoperative 24, 48, 72 hours. The recovery time of postoperative gastrointestinal function is calculated: the first time of exhaust and defecation; postoperative hospital stay; complications, such as surgical site infection, respiratory tract infection, thrombosis, incision debridement, postoperative bleeding, serious cardiovascular complications, death, etc. The incidence of lidocaine toxicity within postoperative 72 hours, including neurological manifestations such as vertigo, tinnitus, and convulsions, cardiac manifestations such as bradycardia, and new severe atrioventricular block. Follow-up after discharge: changes in tumor markers and barrier-free survival at 1 month after surgery; chronic pain at postoperative 3 months and 6 months; tumor markers at postoperative 6 months, 1 year, 3 years and 5 years, relapse-free, barrier-free, and overall survival rates based on enhanced CT, MRI, or ultrasound diagnosis.
日付
| 最終確認済み: | 02/29/2020 |
| 最初に提出された: | 02/15/2020 |
| 提出された推定登録数: | 03/02/2020 |
| 最初の投稿: | 03/03/2020 |
| 最終更新が送信されました: | 03/02/2020 |
| 最終更新日: | 03/03/2020 |
| 実際の研究開始日: | 01/14/2019 |
| 一次完了予定日: | 01/14/2021 |
| 研究完了予定日: | 01/14/2026 |
状態または病気
介入/治療
Drug: Lidocaine group
Drug: Conventional analgesia group
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Experimental: Lidocaine group General anesthesia is induced in the lidocaine group by slow intravenous lidocaine 1.5mg/kg, followed by continuous injection of lidocaine 2mg/kg.h with micropump. At the end of the operation, the patient controlled intravenous analgesia with lidocaine is used, and the dose of lidocaine is 30mg/kg(no more than 2000mg at most) until 3 days postoperation. | Drug: Lidocaine group General anesthesia is induced in the lidocaine group by slow intravenous lidocaine 1.5mg/kg, followed by continuous injection of lidocaine 2mg/kg.h with micropump. At the end of the operation, the patient controlled intravenous analgesia with lidocaine is used, and the dose of lidocaine is 30mg/kg(no more than 2000mg at most) until 3 days postoperation. |
| Placebo Comparator: Conventional analgesia group During anesthesia induction, the loading dose of lidocaine, that is, the maintenance dose, is all replaced by the same amount of normal saline. After the operation, the patient controlled intravenous analgesia without lidocaine is used until 3 days postoperation. | Drug: Conventional analgesia group During anesthesia induction and maintenance, the conventional analgesia group is replaced with the same amount of normal saline until the end of the operation. The patient controlled intravenous analgesia without lidocaine is used until 3 days postoperation. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: - Age: 18-80 years old - American Society of Anesthesiologists(ASA) Ⅰ～III - BMI≤30 - Primary single hepatocellular carcinoma resection was proposed for patients undergoing laparotomy (median incision, right subcostal incision/inverted L-shaped incision) within 6 hours operative time. Exclusion Criteria: - Primary liver cancer with malignant tumors of other organs (such as lung, kidney, intestine, etc.). - Primary hepatocellular carcinoma with portal vein or inferior vena cava and other large vascular thrombus. - Long-term opioid use, alcohol or drug abuse or any of the drugs (lidocaine, etc.) used in this study were contraindicated and allergic for patients. - Patients with severe hepatic and renal dysfunction (total bilirubin >1.46mg/dl, glomerular filtration rate <30ml/min /1.73㎡ or end-stage renal disease). - Severe heart disease (severe heart block (including sinoatrial, atrioventricular, and intraventricular block); Severe heart failure (ejection fraction <20%); Sinus bradycardia; Patients with Adams-Stokes syndrome, preexcitation syndrome, etc - Patients with a history of uncontrolled seizures or acute porphyria. - Long-term use of cimetidine and β-blockers (lidocaine metabolism is inhibited through the liver, resulting in increased blood concentration of the drug, which can lead to adverse cardiac and nervous system reactions). - Patients treated with drugs that are contraindicated with lidocaine (phenobarbital, thiopental, sodium nitroprusside, mannitol, amphotericin B, ampicillin, mesonotal, sulfadiazine sodium); Patients who are using enoxacin, lomefloxacin, norfloxacin, and prulifloxacin. - Patients with a history of gastrointestinal bleeding or perforation after nsaids;Patients with active gastrointestinal ulcers/bleeding or who have had recurrent ulcers/bleeding in the past. - Patients who had taken other experimental drugs or were participating or participating in other clinical trials within 3 months of enrollment. - Failure to cooperate with the study for any reason or the researcher considers it inappropriate to be included in the study. |
結果
主な結果の測定
1. Pain at resting state and activity [the first 24 hours postoperatively]
二次的な結果の測定
1. opioid consumption [Within 3 days after surgery]
2. Incidence of adverse reactions to opioids after operation [Within 3 days after surgery]
3. Pain at resting state and activity [48 hours, 72 hours postoperatively]
4. Satisfaction degree of analgesic effect [72 hours postoperatively]
5. the time of functional gastrointestinal recovery [Within 3 days after surgery]
6. the length of hospital stay [through study completion, an average of 1 year]
7. Incidence of complications [Within 1 month after surgery]
8. The Incidence of lidocaine adverse reactions [Within 3 days after surgery]
9. The incidence of chronic pain [1 month, 3 months postoperatively]
10. Incidence of accessible survival [1 month, 3 months, 6 months, 1 year, 3 years, 5 years postoperatively]
