Clinical trial NCT06086106: Comparison Between the Caudal Block and Other Methods of Postoperative Pain Relief in Children Undergoing Circumcision
Official title: Comparison Between the Caudal Block and Other Methods of Postoperative Pain Relief in Children Undergoing Circumcision: A Prospective Randomized Study"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Pain, Postoperative
Pain, Acute
Keywords: Anesthesia
Pain Management
pediatric
Lead sponsor: Salmaniya Medical Complex
Sponsor class: OTHER_GOV
First posted: 2023-10-17
Enrollment: 90
Sex: MALE
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective, randomized, case-controlled trial study. Observation post-operatively: a study Sample size: all patients, for a total of 90 boys going for circumcision surgery. I was recruited over the course of four months, starting in May 2023. The patients will be divided into three groups: A (CB), B systemic opioids, and C (DPNB). All patients had operations and were observed, and the three groups were compared based on hemodynamic stability, pain scores, duration of sedation, analgesia need, and parental satisfaction. where the Face, Leg, Activity, and Cry Consolability (FLACC) pain scale and behaviors were used to observe and compare the three

Brief summary: Prospective, randomized, case-controlled trial study. Observation post-operatively:

Aims: This study aimed to compare the effectiveness of the caudal block CB with other methods of postoperative pain release.

Detailed description: a study Sample size: all patients, for a total of 90 boys going for circumcision surgery. I was recruited over the course of four months, starting on 1 May 2023. The patients will be divided into three groups: A caudal block(CB), B systemic opioids, and C dorsal penile block (DPNB) Techniques used in pediatric surgeries to provide analgesia for penile surgery such as circumcision. All patients had operations and were observed, and the three groups were compared based on hemodynamic stability, pain scores, duration of sedation, analgesia need, and parental satisfaction. where the Face, Leg, Activity, and Cry Consolability (FLACC) pain scale and behaviors were used to observe and compare the three groups. Pain scores were recorded by separate anesthesiologists or nurses in the post-anesthesia care unit. All statistical work will be carried out using Spss version 27 (Spss Inc., Chicago, USA) and Prism GraphPad version 9.4.1 (GraphPad, San Diego, USA) The categorical and numerical variables and demographic data of three groups were collected and reviewed by two authors. the study has shown that the caudal block produces higher levels of analgesia and a longer period of pain release than the penile block, even if both methods help relieve pain during pediatric surgical procedures.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists Physical Status classification one
* aged from three months up to three years

Exclusion Criteria:

* allergic to local anesthetics,
* bleeding diatheses,
* coagulopathy,
* infection at the injection site,

Primary outcomes:
measure: postoperative pain assessment
timeFrame: "immediately after the intervention/procedure/surgery"
measure: Pain postoperative assessment tools in post anesthesia care unit.
timeFrame: 20 minutes after the intervention/procedure/surgery"
Secondary outcomes:
measure: Differences between children pain scale after 6h
timeFrame: Differences between children who underwent circumcision' surgery with or without caudal block anesthesia in the average pain scores at the various time points, postoperative analgesia between children pain scores after 6hours
Other outcomes:
Locations:
city: Manama
country: Bahrain
facility: Salmanyia Medical Complex
Study officials:
affiliation: salmanyia medical complex
name: Rashed A Albanna, consultant
role: STUDY_DIRECTOR
References:
citation: Gawe ZA, Isa HM, Almashaur MM, Haider F, Almulla K. The Effect of Caudal Anesthesia Block on Perioperative Pain Control and Reduction of the Anesthetic Agent in Pediatric Infraumbilical Surgery: A Prospective Randomized Trial Study. Anesth Essays Res. 2022 Jul-Sep;16(3):301-306. doi: 10.4103/aer.aer_64_22. Epub 2022 Nov 2.
citation: Sandeman DJ, Reiner D, Dilley AV, Bennett MH, Kelly KJ. A retrospective audit of three different regional anaesthetic techniques for circumcision in children. Anaesth Intensive Care. 2010 May;38(3):519-24. doi: 10.1177/0310057X1003800317.
citation: Metzelder ML, Kuebler JF, Glueer S, Suempelmann R, Ure BM, Petersen C. Penile block is associated with less urinary retention than caudal anesthesia in distal hypospadia repair in children. World J Urol. 2010 Feb;28(1):87-91. doi: 10.1007/s00345-009-0420-2. Epub 2009 May 23.
citation: Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003005. doi: 10.1002/14651858.CD003005.pub2.
citation: Ekstein M, Weinbroum AA, Ben-Chaim J, Amar E, Schvartz R, Klein Y, Bar-Yosef Y. Comparison of Caudal Block vs. Penile Block vs. Intravenous Fentanyl Only in Children Undergoing Penile Surgery: A Prospective, Randomized, Double Blind Study. Front Pediatr. 2021 Mar 26;9:654015. doi: 10.3389/fped.2021.654015. eCollection 2021.
citation: Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 10.1097/ALN.0000000000002372.
citation: Baird R, Guilbault MP, Tessier R, Ansermino JM. A systematic review and meta-analysis of caudal blockade versus alternative analgesic strategies for pediatric inguinal hernia repair. J Pediatr Surg. 2013 May;48(5):1077-85. doi: 10.1016/j.jpedsurg.2013.02.030.
citation: H G Salama, M H Elsersi, T S Shabana, J M Mahanna caudal block versus penile block for postoperative analgesia in children undergoing hypospadias repair, QJM: An International Journal of Medicine, Volume 113, Issue Supplement_1, March 2020, hcaa052.006