CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
Group A Caudal Epidural Anesthesia with bupivacaine 0.25% and group B with opioid intervenorscombination
Likely dose
Not stated in record
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Search/NCT05581940
NCT05581940N/ACompleted

The Effect of Caudal Anesthesia Block on Perioperative Pain Control and Reduction of the Anesthetic Agent in Pediatric Infra-umbilical Surgery: A Prospective Randomized Trial Study

Salmaniya Medical Complex·observational·Posted Oct 17, 2022·Updated Oct 17, 2022

In Brief

An observational study evaluating Group A Caudal Epidural Anesthesia with bupivacaine 0.25% and group B with opioid intervenors for Pain, Postoperative and 2 related conditions. Completed, enrolled 72 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBahrain
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 17, 2022
Enrollment StartJan 5, 2020
Primary CompletionJul 10, 2020
Study CompletionJul 19, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.7 years ago

Interventions

Group A Caudal Epidural Anesthesia with bupivacaine 0.25% and group B with opioid intervenorscombination

(CEB) in group A using drugs bupivacaine 0.25% commonly used in children including neonates in group A In infraumbilical operations, it is used as a supplement to GA and to control postoperative pain It is a safe, easy, and effective type of central neuraxial block.\[ The patient will be intubated and the caudal block will be performed under GA after securing the airway. The patient's position will be turned onto the lateral decubitus then a landmark-based, blind technique will be used. In children, the success rate with the blind technique is above 96% but the occurrence of side effects is reported. Group B uses general anesthesia (GA) alone for intraoperative and perioperative pain control used the opioid intervious without caudal block .