- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06086106
Comparison Between the Caudal Block and Other Methods of Postoperative Pain Relief in Children Undergoing Circumcision (paincontrol)
Comparison Between the Caudal Block and Other Methods of Postoperative Pain Relief in Children Undergoing Circumcision: A Prospective Randomized Study"
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Manama, Bahrain, 122001
- Salmanyia Medical Complex
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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,
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
group B systemic opioids for pain relive
systemic opioids belong to a class of analgesics, they act by attaching to opioid receptors in the brain and spinal cord.
For relief of pain, they are frequently utilized in a variety of surgical procedures and can be given intravenously, and in intramuscular injections.
Although opioids are considered highly effective in pain control, they can lead to several adverse effects, such as nausea, vertigo, and respiratory depression, some of which can be dangerous.
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The caudal block involves the injection of a local anesthetic Bupivacaine dose of 0.75 to 1 ml/kg the maximum volume was 10 mL with 0.25% concentration into the caudal epidural space, targeting the sacral nerve roots.
to provide a high effect and duration of analgesia
Other Names:
DPNB is A type of pain control post-operative, often performed as a circumferential infiltration of the root of the penis (ring block).
Two skin wheals are raised at the dorsal base of the penis, one on each side just below and medial to the pubic spine.
A 25-gauge, 37.5-mm needle is introduced on each side, and the bupivacaine (1 to 1.5 mL) maximum dose 2 ml concentration 0.25% for infants is injected superficially and deep along the lower border of the pubic ramus to anesthetize the dorsal nerve.
For a complete ring of infiltration,
Other Names:
Systemic opioids belong to a class of analgesics, they act by attaching to opioid receptors in the brain and spinal cord.
For relief of pain, they are frequently utilized in a variety of surgical procedures and can be given intravenously, and in intramuscular injections.
Although opioids are considered highly effective in pain control, they can lead to several adverse effects, such as nausea, vertigo, and respiratory depression, some of which can be dangerous.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postoperative pain assessment
Time Frame: "immediately after the intervention/procedure/surgery"
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The circumcision of children is the most commonly performed surgical procedure in the world Likely, the greatest target for us as anesthesiologists is to control the pain postoperatively.
Various techniques are used to manage pain.
Two of these techniques are CB and DPNB, both considered as regional blocks and involve the administration of local anesthesia.
Additionally, systemic opioids have shown potential for alleviating postoperative pain.
This study aimed to explore the benefits and limitations of these techniques and provide insights into their effectiveness and impact on circumcised patients.
By evaluating the use of CB, penile block, and opioids, we can recognize their usefulness in promoting safe and painless circumcision surgery.Considering the risk points, DPNB can cause hematoma, opioids can lead to respiratory depression plus nausea and vomiting, while CB can cause delayed micturition, failed block, and cerebrospinal fluid aspiration due to puncture of dura
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"immediately after the intervention/procedure/surgery"
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Pain postoperative assessment tools in post anesthesia care unit.
Time Frame: 20 minutes after the intervention/procedure/surgery"
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To gather information, a questionnaire consisting of two sections, the first section, demographic characteristics including age, and weight, and the second section consisting analgesia scale was used.This tool assesses pain in pediatric patients, preverbal children, and those who cannot express their pain verbally or accurately and is dependent on the assessment by the researcher based on the criteria of this scale.
In this project, zero is analgesia, 1-3 is for mild pain, 4-6 is for moderate pain, and 7-10 is for severe pain the Face Legs a useful tool for parents to detect pain in their infants and young children.
and toddlers
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20 minutes after the intervention/procedure/surgery"
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences between children pain scale after 6h
Time Frame: 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
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Face, Legs, Activity, Cry, Consolability (FLACC) analgesia scale was used .
The scores were observed and recorded during the first 5 min post op then 20 min, 30 min, and 60 min in Post Anesthesia Care unit.
this scale is a standard tool to measure pain severity in which pain severity is scored from zero (analgesia) to 10 (maximum pain).
This tool assesses pain in pediatric patients, preverbal children, and those who cannot express their pain verbally or accurately and is dependent on the assessment by the researcher based on the criteria of this scale.
In this project, zero is analgesia, 1-3 is for mild pain, 4-6 is for moderate pain, and 7-10 is for severe pain .the
pain scores were recorded at the various time points, postoperative analgesia between children pain scores after 6hours
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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
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rashed A Albanna, consultant, Salmanyia Medical Complex
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 70130623
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
CONSORT checklist was used for the enrolment and allocation of patients, Children undergoing circumcision surgery under General Anesthesia (GA) with CB Group A and DPNB Group B, and systemic opioid Group C.
inclusion and exclusion standards: After obtaining approval from the research approval serial number institution Review Board IRB number 7 0130623, informed written consent was obtained from the parents of 90 boys (ASA physical status I), aged from three months up to three years scheduled to undergo circumcision surgery,
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Study Data/Documents
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Individual Participant Data Set
Information identifier: 70130623Information comments: This study was ethically approved by the Research and Research Ethics Committee Government Hospitals, Salmaniya Medical Complex (SMC), Kingdom of Bahrain, institution review board, (IRB) approval number: 70130623, which includes the use of patient data for research and educational purposes was obtained from all the patients/control's parents/guardians before the intervention. This study followed the guidelines laid down in the Declaration of Helsinki of 1975, and as revised in Edinburgh 2000.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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