Pediatric Caudal Anesthesia Block. And Pain Control (CEB)

Salmaniya Medical Complex

Status: Completed

Conditions: Anesthesia, Caudal; Adverse Reaction to Epidural Anesthesia; Pain, Postoperative

Treatments: Combination Product: Group A Caudal Epidural Anesthesia with bupivacaine 0.25% and group B with opioid intervenors

Study type: Observational

Funder types: Other

Identifiers

NCT05581940

123311219

Details and patient eligibility

About

Caudal epidural block CEB is the most commonly performed neuraxial block to provide effective pain relief and analgesia in patients undergoing infra-umbilical pediatric surgery. This study aimed to compare the effectiveness of adding CEB to general anesthesia in terms of intra- and post-operative pain management. Design: Double-unblinded.

Prospective. randomized. Study, Setting: salmanyia medical complex. intraoperative, postoperative recovery room Methods: A total of 72 patients American Society of Anesthesiology physical status classification ASA 1. Patients were equally allocated into two groups Group A and with CEB and Group B without CEB, aged two months to six years. respectively, over a study period of six months. Both groups were compared based on hemodynamic stability, level of sedation, analgesia need, pain score, and parental satisfaction. Postoperative pain was evaluated by four different pain scales.

Full description

the data collection uses a combination of quantitative and qualitative data. Quantitative Data: These include numerical datasets, which can be analyzed with mathematical techniques and are collected based on scales such as numbers of patients with or without CEB, interval, ratio, and ordinal. Resultantly, then the data are surveys and questionnaires, observations of hemodynamics, and behaviors. and data pain scores are collected inside the recovery room and based on the Children's Hospital Eastern Ontario Pain Scale (CHEOPS), Faces Pain Scale-Revised (FPS-R), and Face, Legs, Activity, Cry CONSOL ability (FLACC) scales. That data was collected through four phases, pre-op Intra op and post-op 1 hour in PACU, and six hours post-op was observed by the nurses in the ward. the data is divided into primary and secondary. the primary data were directly collected from the parents and information on the medical history from the files in the hospital was recorded, and the secondary data was collected directly by the anesthesiologist inside the operation room Once the patient was shifted to the operating theatre, the patient's age, sex, weight, height, types of surgeries will be performed, and the type of GA induction and maintenance agents were recorded in the anesthesia charts then in the recovery room, patients, pain scores, and behaviors are monitored according to the regular in the organization, then in the ward are based on questionnaires, observations and comparing the statically significant value between the two groups. The raw data which was collected from case report forms were entered into a Microsoft Excel Spreadsheet initially. Then, the data have been transferred to and analyzed by IBM SPSS Statistics software version 21. The categorical and numerical variables of both groups were analyzed and compared. Data are expressed as n (%), mean ± standard deviation or median and interquartile range (IQR) according to distribution normality. Continuous variables were compared using the Mann-Whitney U test, and categorical variables were compared using Fisher's exact test or Pearson Chi-square test. The confidence interval was set at 95%.

Enrollment: 72 patients

Sex: All

Ages: 3 months to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children aged between two months and six years
• who were undergoing infra-umbilical surgeries
• ASA PS I no any medical issues

Exclusion criteria

• CEB such as sacral anomaly
• bleeding diathesis, patients with neuromuscular disease,
• hemodynamically unstable were excluded from the study.
• Simple randomization was done to select patients who will receive CEB from the daily surgical list. This trial was not blinded.
• In terms of the sample size determination, for a study power of 80% and a probability of type I error of 5%, a total of 74 patients was required for the study.

Trial design

72 participants in 1 patient group

Pediatric caudal anesthesia block.

Description:

caudal epidural block is a neuraxial block to provide effective pain relief and analgesia in pediatrics undergoing infra-umbilical pediatric surgery this study aimed to compare the effectiveness of adding to general anesthesia in terms of Intra and post-op pain management. A prospective, randomized case-controlled.A total of 72 patients aged two months to six years with (ASA PS) I (ASA I) were recruited over a six-month period between December 2019 and May 2020. Patients were allocated into two groups A performed under general anesthesia with caudal block and group B performed under general anesthesia alone. Both groups were compared based on hemodynamic stability, analgesia need, pain score, and parental satisfaction. Postoperative pain was evaluated by the Pain Scale- Categorical and numerical variables of both groups were compared. Results:

Treatment:

Combination Product: Group A Caudal Epidural Anesthesia with bupivacaine 0.25% and group B with opioid intervenors