Pediatric Caudal Anesthesia Block. And Pain Control

NCT05581940 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 72

Last updated 2022-10-17

No results posted yet for this study

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.

Conditions

  • Pain, Postoperative
  • Adverse Reaction to Epidural Anesthesia
  • Anesthesia, Caudal

Interventions

COMBINATION_PRODUCT

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

(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 .

Sponsors & Collaborators

  • Salmaniya Medical Complex

    lead OTHER_GOV

Principal Investigators

  • Zeana Gawe, specialist · salmanyia medical complex

Eligibility

Min Age
3 Months
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-05
Primary Completion
2020-07-10
Completion
2022-07-19
FDA Drug
Yes

Countries

  • Bahrain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05581940 on ClinicalTrials.gov