| ObjectivesLaparoscopic excision of the lesions is widely used in the treatment of gynecological intra-abdominopelvic diseases,which is less invasive to patients,however,some patients are clinically found to have sleep disorders of varying severity after the operation.In this study,we analyzed the effect of intraoperative intravenous lidocaine infusion on postoperative sleep quality in gynecologic patients who were proposed to undergo laparoscopic excision of the lesions as an intervention population.Methods1.Research DesignIn this study,50 patients with gynecological diseases admitted to the Department of Obstetrics and Gynecology of People’s Hospital of Gaoyao District,Zhaoqing City,Guangdong Province were selected,all of whom were diagnosed,seen by the same group of physicians,and proposed to be treated by laparoscopic surgery.Hospital ethics committee approval was obtained prior to the clinical trial,and all patients obtained informed consent prior to enrollment,and the study was conducted in the Department of Anesthesia of People’s Hospital of Gaoyao District,Zhaoqing City,Guangdong Province from September 1,2019 to July 30,2021.The study sticks to the Consolidated Standards of Reporting Trials(CONSORT).2.Inclusion and Exclusion CriteriaPatients included in this trial will be required to meet the following criteria:(1)Preoperative gynecological disease diagnosis is clear and laparoscopic surgery is proposed;(2)The patient’s age range is between 20 and 60 years old,and the body mass index(BMI)range is between 18.5 and 25 kg/m2;(3)Preoperative evaluation by anesthesiologists American Society of Anesthesiologists(ASA)graded patients as Class Ⅰ-Ⅱ;(4)Patients were assessed by Pittsburgh sleep quality index(PSQI)and had no preoperative sleep disorders;(5)Patients without hypertension and diabetes;(6)All patients gave informed consent to the study and signed。All patients enrolled in this study will not be able to have any of the following conditions:(1)Patient’s basal heart rate below 50 beats/min or presence of arrhythmia;(2)Abnormalities in liver and kidney function;(3)Cardiac function class 3～4;(4)Patients who have a previous history of abdominal surgery;(5)Mental or nervous system abnormalities;(6)Patients who are unable to perform functional selfevaluation;(7)Patients who have a previous history of allergy to local anesthetic drugs;(8)Patients with a history of alcohol or drug abuse and poor compliance.3.Research ProjectThe study used a single-center,randomized,double-blind,controlled trial design with a randomized numeric table method to assign all study subjects to two groups:i.e.,experimental and control groups.All patients completed all preoperative preparations,and patients in the experimental group received intravenous lidocaine hydrochloride injection 1.5 mg/kg before induction of general anesthesia,followed by intraoperative maintenance at a rate of 2mg·kg-1·h-1,200 mg of lidocaine and an equal volume of saline were drawn and diluted to 50 ml using the same size syringe by a dedicated person unaware of this study,in which the researchers were unaware of the intervention drug.Equal volume of saline was used in the control group and the rest of the protocol was the same as the experimental group.All subjects were given postoperative analgesia by self-administered intravenous analgesia to alleviate pain.4.Outcome IndicatorsThe primary outcome indicators in this study included PSQI scores and subjective sleep quality scores.PSQI scores were collected from patients at 1 day preoperatively,1 day,3 days,7 days,and 30 days postoperatively.The total score of PSQI is 21,the higher the patient score,the more serious the patient’s sleep disorder and the worse the sleep quality,this study defines PSQI score greater than 7 as sleep disorder.and subjective sleep quality scores were administered to patients 1 d before surgery and 1 and 2 days after surgery,with 0 being very poor sleep and 10 being excellent sleep on the scale.Secondary outcome indicators for this study include:Visual analogue scale(VAS)for pain at 30 min,1h,2h,4h,8h and 24h after surgery;Ramsay sedation scores of patients immediately,30 min,1h,2h,and 4h after surgery;Measurement of melatonin sulfate concentration levels in the urine of patients 1 night before surgery and on the night of surgery,the second night and the sixth night after surgery;The MOS 36-item short form health survey(SF-36)was used to evaluate the patients’quality of life in the first and second months after surgery,with the physical component summary(PCS)and mental component summary(MCS)scores;Adverse reactions in patients within 48h after surgery:including tinnitus,drowsiness,dizziness,intestinal paralysis,nausea and vomiting,and skin rash.5.Statistical analysisPre-experimental results of this study considered PSQI as the main outcome indicator,the standard deviation of the expected mean in the observation group was 2.32,the correlation coefficient at each time point was 0.7,and the two-sided test level a was 0.05,there is a significant difference in the test power of 90%,so the minimum of 20 samples were required in each group of this study,including a total of 40 research subjects.Considering the 20%loss to follow-up rate in clinical studies,25 patients should be included in each group in this study.ResultsNo difference demonstrated in PSQI index and sleep quality score between the two groups 1 day before surgery(p>0.05);At 1,3 and 7 days after surgery,the PSQI index of the experimental group was lower than that of the control group(p<0.05);At 30 days after surgery,no statistically significant difference demonstrated in PSQI indices between the two groups of patients(p>0.05);the sleep quality score of the experimental group was higher than that of the control group 1 day after(p<0.05);Compared with 1day before surgery,the sleep quality score in the experimental group 1day after surgery was not significantly changed compared with before(p>0.05),while it was significantly lower in the control group compared with before(p<0.05);No statistical difference demonstrated between the two groups in sleep quality scores 2 days after surgery(p>0.05).At 30 min,1h,2h and 4h postoperatively,the VAS scores of the experimental group were lower than those of the control group(p<0.05);at 8 and 12h postoperatively,no difference demonstrated in pain scores between the two groups(p>0.05).In the Ramsay sedation scores of the two groups,no difference was seen in the immediate postoperative and 2h postoperative levels(p>0.05);30min and 1h postoperatively,the scores of the experimental group were lower than those of the control group(p<0.05).Melatonin concentration in the morning urine,intra-group comparison:melatonin concentration in the morning urine of the experimental group decreased on the 1st and 3rd postoperative days compared to the preoperative days(p<0.05),and the difference between the concentrations on the 7th postoperative day compared to the preoperative days was not statistically significant(p>0.05);Melatonin concentration in the morning urine of the control group was lower on postoperative days 1 and 3 compared to preoperative days(p<0.05),and the difference was not statistically significant on day 7 compared to preoperative days(p>0.05).Comparison between groups:The melatonin concentration in the experimental group was significantly lower than that in the control group on the third postoperative day,and the difference between the two groups was statistically significant(p<0.05).At 1 month after surgery,the somatic health score and mental health score of the experimental group were higher than those of the control group(p<0.05);at 2 months after surgery,the MCS score of the experimental group was higher than that of the control group,and the difference was statistically significant(p<0.001),and the difference in PCS score between the two groups was not statistically significant(p>0.05).The incidence of perioperative rash was higher in the experimental group compared with the control group(P<0.05),and the risk of dizziness,nausea and vomiting,drowsiness,and intestinal paralysis was lower compared with the control group(P<0.05).ConclusionThe study found that intravenous infusion of lidocaine in gynecological laparoscopic surgery could improve the postoperative analgesic effect and sleep quality of patients,and,meanwhile,could shorten the hospital stay,reduce the incidence of adverse reactions and promote postoperative recovery,which is worthy of clinical promotion. |
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