Pediatric Caudal Anesthesia Block. And Pain Control

Pain, Postoperative Clinical Trial

— CEB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05581940
• Other study ID #: 123311219
• Status: Completed
• Start date: January 5, 2020
• Est. completion date: July 19, 2022

Study information

• Verified date: October 2022
• Source: Salmaniya Medical Complex
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 19, 2022
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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 .

Locations

Country	Name	City	State
Bahrain	Salmanyia Medical Complex	Manama

Sponsors (1)

Lead Sponsor	Collaborator
Salmaniya Medical Complex

Country where clinical trial is conducted

Bahrain, 

References & Publications (13)

Banerjee A, Das B, Mukherjee D, Khanra M. A study of the effect of caudal epidural block on bispectral index targeted propofol requirement in children: A comparative study. J Indian Assoc Pediatr Surg. 2015 Apr-Jun;20(2):77-81. doi: 10.4103/0971-9261.1515 — View Citation

Ben-David B, Vaida S, Gaitini L. The influence of high spinal anesthesia on sensitivity to midazolam sedation. Anesth Analg. 1995 Sep;81(3):525-8. — View Citation

Hicks CL, von Baeyer CL, Spafford PA, van Korlaar I, Goodenough B. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001 Aug;93(2):173-183. doi: 10.1016/S0304-3959(01)00314-1. — View Citation

Joo J, Kim J, Lee J. The prevalence of anatomical variations that can cause inadvertent dural puncture when performing caudal block in Koreans: a study using magnetic resonance imaging. Anaesthesia. 2010 Jan;65(1):23-6. doi: 10.1111/j.1365-2044.2009.06168 — View Citation

Kao SC, Lin CS. Caudal Epidural Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:9217145. doi: 10.1155/2017/9217145. Epub 2017 Feb 26. Review. — View Citation

Kim YH, Park HJ, Cho S, Moon DE. Assessment of factors affecting the difficulty of caudal epidural injections in adults using ultrasound. Pain Res Manag. 2014 Sep-Oct;19(5):275-9. Epub 2014 Aug 11. — View Citation

Manchikanti L, Cash KA, Pampati V, McManus CD, Damron KS. Evaluation of fluoroscopically guided caudal epidural injections. Pain Physician. 2004 Jan;7(1):81-92. — View Citation

Nikooseresht M, Hashemi M, Mohajerani SA, Shahandeh F, Agah M. Ultrasound as a screening tool for performing caudal epidural injections. Iran J Radiol. 2014 May;11(2):e13262. doi: 10.5812/iranjradiol.13262. Epub 2014 May 15. — View Citation

Ozen V, Yigit D. A comparison of the postoperative analgesic effectiveness of low dose caudal epidural block and US-guided dorsal penile nerve block with in-plane technique in circumcision. J Pediatr Urol. 2020 Feb;16(1):99-106. doi: 10.1016/j.jpurol.2019 — View Citation

Senoglu N, Senoglu M, Oksuz H, Gumusalan Y, Yuksel KZ, Zencirci B, Ezberci M, Kizilkanat E. Landmarks of the sacral hiatus for caudal epidural block: an anatomical study. Br J Anaesth. 2005 Nov;95(5):692-5. Epub 2005 Sep 9. — View Citation

Shamim F, Ullah H, Khan FA. Postoperative pain assessment using four behavioral scales in Pakistani children undergoing elective surgery. Saudi J Anaesth. 2015 Apr-Jun;9(2):174-8. doi: 10.4103/1658-354X.152874. — View Citation

Shin SK, Hong JY, Kim WO, Koo BN, Kim JE, Kil HK. Ultrasound evaluation of the sacral area and comparison of sacral interspinous and hiatal approach for caudal block in children. Anesthesiology. 2009 Nov;111(5):1135-40. doi: 10.1097/ALN.0b013e3181bc6dd4. — View Citation

Suresh S, Long J, Birmingham PK, De Oliveira GS Jr. Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Anesth Analg. 2015 Jan;120(1):151-156. doi: 10.1213/ANE.0000000000000446. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	demographic data in two groups recorded and compared intra operation room.	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".
Primary	hemodynamics changed in Bothe groups intra op and one hour and six hours post op	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 .
Primary	pain scores and sedation degree of children through one and six hours post operation in both groups	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	Differences in CHEOPS Score (4-13) d\through one hour and six hours post operation. between group A and B	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.