Sponsor study identifier
observational
72
1 country
1
Study Start
January 5, 2020
Actual (reported)Primary Completion
July 10, 2020
Actual (reported)Study Completion
July 19, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 19, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 5, 2020
Actual (reported)July 10, 2020
Actual (reported)July 19, 2022
Actual (reported)July 31, 2022
Actual (reported)October 17, 2022
Actual (reported)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".
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 .
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:
(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 .
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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).,
Salmanyia Medical Complex
Manama, 122001, Bahrain
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.
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: 10.4103/0971-9261.151551.
Zeana Gawe, specialist
salmanyia medical complex
72 participants (actual enrollment reported by the registry).
First Submitted
July 31, 2022
First Posted
October 17, 2022
Study Start
January 5, 2020
Actual (reported)Efficacy of Adding Dexmedetomidine as an Adjuvant to Bupivacaine in TAP Block and Caudal Block
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,
Differences in CHEOPS Score (4-13) d\through one hour and six hours post operation. between group A and B
through study completion, an average of 1 year pain scale that is used to assist the pain in children in bout groups.
Contact the study team to confirm eligibility.
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.
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. doi: 10.1093/bja/aei236. Epub 2005 Sep 9.
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.
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.2019.10.020. Epub 2019 Oct 30.
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.
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. doi: 10.1155/2014/679128. Epub 2014 Aug 11.
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.
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. doi: 10.1097/00000539-199509000-00017.
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.x. Epub 2009 Nov 17.
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.
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.
Primary Completion
July 10, 2020
Actual (reported)Study Completion
July 19, 2022
Actual (reported)Last Updated
October 17, 2022
Record last verified: 2022-10
the research data is intended for this research only and not to share in another research .and data were analyzed according to the protocol
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Source: ClinicalTrials.gov.
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