Pediatric Caudal Anesthesia Block. And Pain Control (CEB)

October 12, 2022 updated by: Zeana gawe, Salmaniya Medical Complex

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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%.

Study Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bahrain
      • Manama, Bahrain, 122001
        • Salmanyia Medical Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CONsolidated Standards of Reporting Trials (CONSORT) checklist was used for enrolment and allocation of patients. Children aged between two months and six years who were undergoing infra-umbilical surgeries with ASA PS I were randomly allocated to either group A (GA with CEB) or to group B (GA without CEB).,

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric caudal anesthesia block.
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:
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 .
Other Names:
  • Regional anesthesia intervention and pain control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
demographic data in two groups recorded and compared intra operation room.
Time Frame: Demographic data of children in both groups. Recorded through study completion, an average of 1 year".
the patient's in two groups .The demographic data for all patients as age\months, sex\female ,male, weight( kilogram ,Height\centimeter were recorded in the anesthesia chart.
Demographic data of children in both groups. Recorded through study completion, an average of 1 year".
hemodynamics changed in Bothe groups intra op and one hour and six hours post op
Time Frame: through study completion, an average of 1 year". Measures of change in bassline of hemodynamic stability in both groups A and B Period preop and interop and post operation the data are presented as mean ± standard deviation .
the Baseline Systolic and diastolic Blood Pressure pre operation and intraoperation and 60 minuet post operation have been recorded in group A and group B..
through study completion, an average of 1 year". Measures of change in bassline of hemodynamic stability in both groups A and B Period preop and interop and post operation the data are presented as mean ± standard deviation .
pain scores and sedation degree of children through one and six hours post operation in both groups
Time Frame: through study completion, an average of 1 year Continuous variables were compared period one hour and 6 hours post op using Mann-Whitney U.df=degree of freedom,
pain scores at the various time points, and postoperative analgesia Based on the Face, Legs, Activity, Cry, consolability (FLACC) scale is a measurement used to assess pain for children between the age of 2 month and 7 years or individuals that are unable to communicate their pain .the scale is scored range from 0 to 10 with 0 is presenting no paint the scale has five criteria witch are each assigned a score of 0,1 or ,2,
through study completion, an average of 1 year Continuous variables were compared period one hour and 6 hours post op using Mann-Whitney U.df=degree of freedom,

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in CHEOPS Score (4-13) d\through one hour and six hours post operation. between group A and B
Time Frame: through study completion, an average of 1 year pain scale that is used to assist the pain in children in bout groups.
All Children have been observed by nurses and anesthesiologists in post anesthesia care unit using the children s Hospital Estern Ontario Pain ScaleCHEOPS is a behaviors pain scale in young children for evaluating postoperative pain it used to monitor the effectiveness of interventions for reducing the pain and discomfort .CHEOPS pain score is sum points for the all 6 parameters cry. facial. touch. legs. child verbal. Torso. the score ranging from 4 to 13 where is considered above 5 presented of pain .and the score recorded at the 30 minutes .and 60 minutes add to 6 hours post operation. Using Mann-Whitney U test and categorical variables were compared using *Fisher's exact test or †Pearson Chi-square test. P value is considered statistically significant and, degree of freedom, confidence interval
through study completion, an average of 1 year pain scale that is used to assist the pain in children in bout groups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salmaniya Medical Complex

Investigators

  • Principal Investigator: Zeana Gawe, specialist, Salmanyia Medical Complex

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2020

Primary Completion (Actual)

July 10, 2020

Study Completion (Actual)

July 19, 2022

Study Registration Dates

First Submitted

July 31, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

October 17, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 123311219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

the research data is intended for this research only and not to share in another research .and data were analyzed according to the protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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