Pediatric Caudal Anesthesia Block. And Pain Control

NCT05581940 | Completed DMC FDA Drug

• 1 other identifier: 123311219
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

caudal; Pain Management; Anesthesia; pediatric

Outcome Measures

Primary Outcomes (3)

• 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 .

• 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 Outcomes (1)

• 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.

Study Arms (1)

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

Interventions

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

(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 .

Also known as: Regional anesthesia intervention and pain control

Pediatric caudal anesthesia block.

Eligibility Criteria

• Age: 3 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).,

You may qualify if:

• Children aged between two months and six years
• who were undergoing infra-umbilical surgeries
• ASA PS I no any medical issues

You may not qualify if:

• 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.

Sponsors & Collaborators

• Salmaniya Medical Complex: lead

Study Sites (1)

Salmanyia Medical Complex

Manama, 122001, Bahrain

Location

Related Publications (13)

• 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.

  PMID: 25393589 BACKGROUND

• 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.

  PMID: 25829671 RESULT

• 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.

  PMID: 25829906 RESULT

• 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.

  PMID: 16155035 RESULT

• 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.

  PMID: 28337460 RESULT

• 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.

  PMID: 31759904 RESULT

• 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.

  PMID: 25035698 RESULT

• 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.

  PMID: 25111987 RESULT

• 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.

  PMID: 19809281 RESULT

• 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.

  PMID: 7653816 RESULT

• 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.

  PMID: 19922508 RESULT

• 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.

  PMID: 16868617 RESULT

• 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.

  PMID: 11427329 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Bupivacaine; Analgesia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia and Analgesia

Study Officials

• Zeana Gawe, specialist

  salmanyia medical complex

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Of Anesthesia

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: October 17, 2022
• Study Start: January 5, 2020
• Primary Completion: July 10, 2020
• Study Completion: July 19, 2022
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)