Sacral Circumcision Surgery: Comparison of the Effects of Erector Spina Plane Block and Ring Block on Postoperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Face, Legs, Movement, Crying, Avocative Behavioral Scale
研究概览
简要总结
Although it is not known exactly when and where circumcision was first performed, it is claimed that it was first performed by the Egyptians, according to various beliefs and traditions. Circumcision is the surgical removal of the skin surrounding the glans penis in pediatric male patients and is the most commonly performed surgery in boys (4). Because the foreskin is sensitive and the pain threshold is low, patients experience severe pain in the postoperative period. Various analgesic methods have been developed to reduce this pain. Sacral surgery has started to be used in adult patients in recent years, but there is not enough information about its application in pediatric patients. Sacral erector spinae plane block is on the agenda. While sacral erectör spinae plane block was first applied in gender reassignment and pilonidal sinus surgery in adults, it was also applied to a small extent in hypospadias and anoplasty surgery in pediatric patients. In some studies, circumcision surgery involves the root and distal parts of the penis. It has been emphasized that ring blocks applied with anesthesia also have an analgesic effect. Our aim in this study was to compare the effect of S-ESPB and ring block on postoperative Face, Legs, Movement, Crying, Avocative Behavioral Scale pain scores in pediatric patients undergoing circumcision surgery and to compare the number of patients who required rescue analgesia, the time until the first rescue analgesia, possible complications, and parental satisfaction (a Likert scale will be used).
In this study, we found that sacral erectör spinae plane block is different from the ring block applied in routine practice in circumcision surgery. We think that postoperative analgesic effectiveness will be higher.
Our aim in this study was to compare the effect of sacral erectör spinae plane block and ring block on postoperative Face, Legs, Movement, Crying, Avocative Behavioral Scale pain score in pediatric patients undergoing circumcision surgery and to compare the number of patients who required rescue analgesia secondarily, the time until the first rescue analgesia, possible complications and parental satisfaction (Likert scale will be used).
详细描述
Our primary hypothesis erectör spinae plane block will be effective in pediatric patients undergoing circumcision surgery. The effect on postoperative pain will be greater than the applied ring block and the Face, Legs, Movement, Crying, Avocative Behavioral Scale pain score will be lower.
Our secondary hypothesis is that the number of patients requiring rescue analgesia and the complications that may occur will be lower in sacral erectör spinae plane block to be applied in circumcision surgery compared to the ring block, and parental satisfaction and the time until the first rescue analgesia will be higher.
Material oath methods: Our study will be carried out within 6 months with 50 patients in the operating room of Konya City Hospital of the University of Health Sciences and the operating room of Harran University Faculty of Medicine Randomization This study was a multicenter prospective study. It was planned and will be carried out as a randomized study. Randomization will be carried out by the sealed envelope method. Patients will be divided into two groups: Group R (patients who underwent Ring block) and Group S (patients who underwent sacral erectör spinae plane block). Since it is a multicenter study, the anesthesia technique will be applied by two different physicians with at least five years of clinical experience and the postoperative results will be recorded by 2 different physicians. These physicians will evaluate patients completely independently and blindly. Written and verbal consent will be obtained from the patient's parents.
Anesthesia Technique and Analgesia Protocol:
Routine anesthesia monitoring and method will be applied to all patients. 22 gauge to patients Intravenous ( IV ) cannulation is provided and 15cc/kg/ h Isotonic fluid will be started. General anesthesia induction 1mg midazolam IV, 2 mg/kg propofol IV, and 1 mcg /kg remifentanil It will be done by giving IV. The patients will be fitted with a laryngeal mask airway (LMA), which we use in routine practice, and will require minimum anesthesia maintenance. alveolar Sevoflurane will be given with a concentration (MAC) value of 1. Before the surgical procedure begins, sacral erectör spinae plane block will be applied to the patients by the anesthesiologist or ring block by the pediatric surgeon. Then circumcision surgery will begin. The same surgical method will be applied to all patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients between the ages of 4-16
- •patients with ASA I-II.
- •Patients who will receive general anesthesia
排除标准
- •Parents and patients who do not want to give consent
- •Patients with ASAIII and above
- •Patients with a disordered bleeding profile
- •Patients using anticoagulants
- •Patients with infection in the area to be treated
结局指标
主要结局
Face, Legs, Movement, Crying, Avocative Behavioral Scale
时间窗: FİVE MONTHS
Primary evaluation criteria are the Face, Legs, Movement, Crying, Avocative Behavioral Scaleof pain at rest and movement at 0, 1, 2, 4, and 6 hours after surgery (0-10, 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7- It will be evaluated with 10 = the most severe pain).
次要结局
- Postoperative rescue analgesia(FİVE MONTHS)
研究者
Muhammed Halit Satici
Specialist, Department of Anesthesiology, Konya City Hospital, M.D
Konya City Hospital