Comparison Between the Caudal Block and Other Methods of Postoperative Pain Relief in Children Undergoing Circumcision

NCT06086106 | Completed DMC

• 1 other identifier: 70130623
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Pain, Postoperative; Pain, Acute

Keywords

Anesthesia; Pain Management; pediatric

Outcome Measures

Primary Outcomes (2)

• postoperative pain assessment

  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

  "immediately after the intervention/procedure/surgery"

• Pain postoperative assessment tools in post anesthesia care unit.

  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

  20 minutes after the intervention/procedure/surgery"

Secondary Outcomes (1)

• Differences between children pain scale after 6h

  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

Study Arms (1)

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.

Procedure: caudal block; Procedure: Dorsal Penile Nerve Block DPNB; Drug: Systemic opioids

Interventions

caudal block PROCEDURE

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

Also known as: Regional anesthesia intervention

group B systemic opioids for pain relive

Dorsal Penile Nerve Block DPNB PROCEDURE

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,

Also known as: Regional anesthesia intervention.

group B systemic opioids for pain relive

Systemic opioids DRUG

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.

Also known as: opioids analgesic

group B systemic opioids for pain relive

Eligibility Criteria

• Age: 3 Months - 3 Years
• Gender Eligibility Details: patients, for a total of 90 boys going for circumcision surgery, aged from 3 months up to 3 years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Salmaniya Medical Complex: lead

Study Sites (1)

Salmanyia Medical Complex

Manama, 122001, Bahrain

Location

Related Publications (8)

• 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.

  PMID: 36620118 BACKGROUND

• 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.

  PMID: 20514962 BACKGROUND

• 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.

  PMID: 19466428 BACKGROUND

• 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.

  PMID: 18843636 RESULT

• 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.

  PMID: 33842412 RESULT

• 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.

  PMID: 30074928 RESULT

• 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.

  PMID: 23701786 RESULT

• 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

  RESULT

MeSH Terms

Conditions

Agnosia; Pain, Postoperative; Acute Pain

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Rashed A Albanna, consultant

  salmanyia medical complex

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: October 17, 2023
• Study Start: May 1, 2023
• Primary Completion: August 20, 2023
• Study Completion: August 26, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data is ready to upload starting 1/5/2023 end 20\\8\\2023
• Access Criteria: All 90 patients poysAll 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.

Locations

BA (1)