Aim of the study
The primary aim of this study is to describe the role of PI in evaluating the predictive effect of SCB in children under general anesthesia with sevoflurane and propofol. The secondary aim is to observe whether PI could predict the success of SCB by responding to ulnar nerve block. In addition, explore which general anesthesia method combined with PI can better judge the effect of SCB in children.
Design of the study
This is a prospective observational study. It intends to observe cases of pediatric upper limb surgery performed in Tongji Hospital from May 2021 to May 2022. Groups were divided by random number table method, single blind. According to anesthesia induction and maintenance, they will be divided into propofol group and sevoflurane group. PI values of index finger and little finger in the blocked and non-blocked sides will be recorded in all children. Compare the baseline values and analyze the relationship between the changes in PI values for complete block, partial block, and block failure in each group. A comparative analysis of sevoflurane and propofol block cases will find out which general anesthesia method combined with PI can better judge the effect of supraclavicular brachial plexus block in children. The flowchart of this study is presented in Fig.1.
Sample size
According to literature reports [15], the probability of ulnar nerve insufficiency is less than 20%, the sample size is calculated: As shown in the table 1, the preliminary estimated sample size is 47 cases, and the shedding rate is assumed to be 10%. The calculation is 52 cases per group, so 104 children will be included in this experiment.
Table 1
Sample size estimation results
Inclusion and exclusion criteria
Inclusion criteria: Children from 1 month to 12 years; ASA Class I-II; elective upper extremity surgery in children; signed informed consent.
Exclusion criteria: Refusal by family members; children with altered behavior; inflection at the puncture site; other regional anesthesia contraindications.
Interventions
The guardian signs the consent form and randomly divides the children who meet the inclusion criteria into two groups, and the random number table generated by the computer. Sevoflurane group (SEV group): Inhalation of sevoflurane (5%-8%) for induction of anesthesia, sufentanil 0.2 mg/kg, penehyclidine hydrochloride 0.01mg/kg, dexamethasone 0.1 mg/kg. Place the required type of laryngeal mask, and maintain anesthesia with 1.0 MAC value of sevoflurane + 50% oxygen. Propofol group (PRO group): Propofol 3 mg/kg, sufentanil 0.2 mg/kg, penehyclidane hydrochloride 0.01 mg/kg, dexamethasone 0.1 mg/kg are given for anesthesia induction. Place the required type of laryngeal mask, and propofol 3 mg/kg/h is given for anesthesia maintain.
The children will be given a slow intravenous bolus of 0.1 mg/kg midazolam for sedation during the waiting period. After entering the operating room, routinely monitor the electrocardiogram, blood oxygen saturation and blood pressure. After induction with propofol 3 mg/kg or inhalation of sevoflurane, a laryngeal mask will be placed. Pump propofol or inhalation of sevoflurane for anesthesia maintenance, and then all children will be placed in a supine position with their head tilted to the opposite side. Under ultrasound guidance, an experienced anesthesiologist will use an in-plane needle to block the supraclavicular nerve, and give 0.25% ropivacaine 0.4 ml/kg.
Outcome measures
The age, gender, ASA classification, BMI, anesthesia time, operation time, anesthesia recovery time, duration of stay in PACU, duration of postoperative hospital stay will be recorded. PI values of index finger and little finger will be recorded before induction of general anesthesia in the operating room, immediately after laryngeal mask placement, 5 min, 10 min, 15 min after SCB, immediately after surgery, after removal of laryngeal mask when the child is awake, and the child in PACU. Record the dosages of opioids and vasoactive drugs during the operation. Evaluate the complications and quality of awakening in children. (1) Assessment of restlessness and delirium during the recovery period: 30 min after surgery in PACU. (2) Postoperative pain score. Postoperative complications: nausea and vomiting, neurological dysfunction, Horner syndrome, respiratory depression, etc.
Block effect evaluation
Complete block: There is no significant fluctuation of the heart rate, blood pressure and respiration during the whole operation (heart rate and blood pressure increased by less than 10% compared with the baseline value, and respiratory rate increased by less than 20%). Partial block: When the surgical site is innervated by non-single nerve, there is a certain innervated area that causes heart rate, blood pressure, and respiratory fluctuations (heart rate, blood pressure increase ≥ 10% from the baseline value, respiratory rate increase ≥ 20%), while there is no significant fluctuation in operation in other innervated area. Block failure: Operation in any innervated area caused significant fluctuations in heart rate, blood pressure and respiration. For partial block and failure of block, a single dose of sufentanil (0.01 mg/kg) and a pump of 0.1-0.2 mg/kg/min remifentanil for supplementary analgesia.
Statistical analyses
Analyses will be performed using SPSS statistical software (version 19.0). Categorical variables are represented by frequency, and continuous variables are represented by mean ± standard deviation or median [interquartile range]. Chi-square test or Fisher test will be used for comparison between groups of classified variables, and t-test, analysis of variance or rank sum test will be used for comparison between groups of continuous variables. Logistic regression model will be used to analyze the influencing factors of anesthesia effect and complications, and stepwise regression will be used to screen independent variables.
Possible benefits of participation
All children undergoing ultrasound-guided supraclavicular brachial plexus block for anesthesia can improve postoperative pain, reduce the use of postoperative analgesics, and promote the recovery. In addition, the study will also benefit children undergoing upper limb surgery in the future.
Possible adverse reactions, risks and discomforts
This study is an observational study. The possible adverse and risks are all inherent complications and risks in surgical treatment and anesthesia, and no additional adverse reactions and risks are added.