Japanese Journal of Clinical Oncology, 2020, 50(8)867–872 doi: 10.1093/jjco/hyaa060 Advance Access Publication Date: 15 May 2020 Original Article Original Article Study on the prevention of infection in terminal cancer patients applying epidural analgesia by adding cefazolin to anesthetics: a randomized Downloaded from https://academic.oup.com/jjco/article/50/8/867/5837331 by guest on 01 October 2021 controlled trial Pengcheng Xie*, Zhanfang Li*, Jingli Yang and Yiming Wu Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Pudong, Shanghai, China *For reprints and all correspondence: Pengcheng Xie, Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai 201399, China. E-mail: [email protected] and Zhanfang Li. E-mail: [email protected] Received 1 March 2020; Editorial Decision 13 April 2020; ; Accepted 14 April 2020 Abstract Objective: To observe the antibacterial effect of adding cefazolin into anesthetics in patients with terminal cancer undergoing long-term epidural analgesia. Methods: Patients undergoing epidural analgesia with terminal cancer were randomly divided into two groups: the conventional drug group (group C) and the cefazolin group (group G). Both groups were given levobupivacaine and morphine, while cefazolin was added to group G. The mean arterial pressure (MAP), heart rate (HR), respiratory rates (R), visual analogue scale (VAS) scores, satisfaction and complications of patients in the two groups were observed. 3 ml of the used analgesic was taken for bacterial culture when replacing the new analgesic case. Results: HR, MAP, R, VAS scores, dosages of morphine, satisfaction of the analgesic and the complications were not significantly different between the two groups (P > 0.05). The overall satisfaction of patients in group G was significantly higher than that in group C (P < 0.05). One patient’s anesthetics in group C were infected with colibacillus. Four patients in group C got infected in their epidural puncture sites. There was no infection in group G (P < 0.05). Conclusion: Adding cefazolin to local anesthetics could effectively prevent bacterial infection and ensured the safety of epidural analgesia for patients with terminal cancer. Key words: anesthetics, patients with cancer, epidural analgesia, infection Introduction the life quality of patients, and effective analgesic treatment is Factors such as high work pressure, unhealthy diet, irregular working particularly important to improvement of the life quality of patients hours and polluted environment contribute to the increasing number with terminal cancers. Medical workers have been trying their best of cancer patients. There are many complications in patients with to alleviate the pain of patients for a long time, so as to improve the terminal cancers, among which severe pains are undoubtedly the life quality of patients with terminal cancers (2–4). biggest factor reducing the life quality of patients. Studies have shown With the popularization of patient-controlled analgesia (PCA), that 75% of cancer patients experienced varying degrees of pains, epidural analgesia with high efficiency and low complications had with 40–50% experiencing severe pains and 25–30% experiencing attracted more and more attention of patients with terminal cancer. intolerable pains (1). Cancer pain is an important factor affecting This required large doses of epidural anesthetics, but the sterility © The Author(s) 2020. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: [email protected] 867 868 Epidural analgesia for terminal cancer patients and stability of the compound analgesic solution limit its extensive province, China) was added to group G and none to group C. These clinical application in cancer analgesia. In this study, researchers analgesics could support the treatment for 4–5 days. Analgesics were added cefazolin to epidural analgesics to observe the effectiveness refilled by a doctor applying the same recipe. Infusion pump usage: in preventing bacterial infection. first dose 2 ml, background dose 2 ml·h−1, single additional dose 0.5 ml, 15 min automatic lockup and maximum output 4 ml·h−1. The case was replaced when the liquid was about to run out. 3ml of Materials and methods the left liquid was sent for bacterial culture. Participants Patients with VAS scores higher than 4 were treated with 5 mg of morphine orally. All patients were treated with no other analgesics This study was a prospective, randomized, comparative and double- but antitumor drugs. If the patients had intolerable complications, blind controlled trial. It has been reported in line with the Consol- the amount of epidural anesthetics should be reduced or even dis- idated Standards of Reporting Trials (CONSORT 2010) guidelines. continued. And the study should be discontinued. The study protocol was approved by the Human Research Ethics Duration of the catheter placement: the catheter was retained Committee and registered on August 2018. This study followed for life unless otherwise specified. The catheter was immediately standardized ethical and safety principles of Good Clinical Practice Downloaded from https://academic.oup.com/jjco/article/50/8/867/5837331 by guest on 01 October 2021 removed if the epidural space infection or the epidural catheter guidelines and the declaration of Helsinki. Based on written informed strayed into the subarachnoid space or the epidural catheter came consents, 127 patients with terminal cancers (patients with TNM out. staging III and IV) were enrolled in this study between August 2018 All patients were hospitalized for 3 days to observe the analgesic and April 2019. Patients were allocated randomly according to a effect. They could choose to be hospitalized or discharged to continue computer-generated sequence of random numbers, to undergo with treatment if there was no complications. The patients’ conditions conventional drugs (group C with 63 patients) or cefazolin (group and parameters were followed up by the residents. Symptomatic G with 64 patients). Drug resistance had developed in oral and treatment was performed, and the disease was carefully observed if intravenous opioid analgesics for these patients. Inclusion criteria: complications occurred. ASA I–III; patients with abdominal, pelvic or lower limbs’ cancer; aged 30–75 year old; and being able to fill up VAS score table. Exclusion criteria: hypertension patients with poor control, severe arrhythmia, poor function of the heart and lung, acid–base or elec- Data records trolyte disturbance, severe anemia, spinal metastasis, smoking his- The patients’ basic vital signs were recorded, and 3 ml of anesthetics tory, psychotropic drugs abuse, history of mental illness, infection at was extracted for bacterial culture. MAP, HR, R, VAS scores and the puncture site, allergy to cefazolin and steroid treatment. complications were recorded every 15 min for 2 h after puncture finished. Patients’ vital signs and VAS scores were recorded on day 2, Paracentesis 4, 6, 8, 10, 15, 20, 25, 30 and 35 after the treatment. The total All epidural catheterization procedures were performed by the same oral dose of morphine was recorded. Complications were observed: two trained anesthetists who were unaware of the patient’s ran- urinary retention, cutaneous pruritus, rashes, nausea and vomiting, domization. The residents who did not participate in the study dizzy, headache, dyspnea and constipation. The satisfaction of the made records of the data during and post-epidural puncture. On analgesic, overall satisfaction and total number of infections were the day of the paracentesis, patients were delivered to the operating recorded. 3 ml of the used analgesic was taken for bacterial culture room at 8.30 a.m. Heart rate (three-lead ECG), noninvasive arterial when replacing the new analgesic pump case. pressure and oxygen saturation were continuously monitored during Overall satisfaction: patients were distributed with questionnaire −1 the procedure; supplemental oxygen (2 l min ) was administered to comment on the doctors’ service attitude, quality of answers, via nasal prongs. explanation of particular diseases, professionalism, privacy protec- All patients were placed in a lateral position and received punc- tion and treatment effectiveness on complications. Each item was ture needle through the median of L2–L3 space. 5 ml of 1% lidocaine scored on a 10-point scale, aggregated to 60 points at maximum. was injected after the epidural catheterization was successful. The If the patient’s anesthetics got infected, epidural catheter should catheter was placed into epidural space for 4 cm, and a subcutaneous be removed, and the study should be terminated. The patients were 5 cm tunnel was established towards the cephalic side. The epidural given the appropriate antibiotic orally in a leukocytosis situation, catheter was pulled and connected to the bacterial filter and the under careful monitoring for fever and infection in epidural space. analgesic case in order (Apon medical company, Apon filter and Apon analgesic case, Nantong, Jiangsu province, China). Sensory regression was measured by blunt needles 10 min later.The block was considered successful when the anesthesia level was between T8 and Statistical analysis S5. When the subarachnoid anesthesia occurred or the block failed, The primary endpoint was none of the patients were infected on day the patients