Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children

NCT05233683 | Unknown Phase 3

• 1 other identifier: E-21-5965
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Circumcision is one of the most commonly performed operations in the pediatric population and is a painful procedure. Circumcision is performed with two popular techniques, Plastibell and conventional dissection method (CDM). For intra-operative (OP) and post-OP pain relief, two commonly used local anesthetic techniques are caudal block (CB) and dorsal penile block (DPNB) plus ring block (RB) at the base of the penis. There are very few randomized controlled trials comparing these two methods of intra-OP and post-OP pain relief, for different surgical techniques and there is a lack of well-conducted studies comparing the quality of analgesia, need for rescue analgesia in the early post-OP period, complications, and parental satisfaction comparing these blocks. Furthermore, there is a lot of contradiction in the literature regarding the duration of analgesia produced with these techniques.

Conditions

Anesthesia; Anesthesia, Local; Analgesia; Pediatric ALL; Pain, Postoperative; Pain, Acute

Outcome Measures

Primary Outcomes (2)

• Efficacy of analgesia using FLACC Scale

  Postoperatively in the PACU, the child will be observed in the recovery room by a senior nurse blinded to the anesthetic technique and the FLACC score will be used for pain assessment (copy attached). The FLACC scale is a uni-dimensional behavioral pain assessment instrument to measure pain in young children in the post-OP period. It includes five items (Face, Leg, Activity, Cry, and Consolability) and has good inter-rater reliability (Kappa 0.52-0.82), as well as good content and convergent validity. The scale is scored in a range of 0-10 with 0 = no pain and 10 = severe pain. The FLACC is reliable in critically ill young children. The severity of pain will be classified using the total score 0=no pain, and 10= severe pain. I.V fentanyl will be administered in the dose of 0.5 mic/kg if the pain score is \>5 and the dose will be repeated if the FLACC score persisted \>5 after five minutes.

  First 12 hours after surgery/intervention (circumcision)

• Duration of analgesia

  To compare the duration of post-OP analgesia produced by CB and DPNB plus RB in children undergoing circumcision with two different surgical techniques.

  First 12 hours after surgery/intervention (circumcision)

Secondary Outcomes (13)

• Number of participants that needed rescue analgesia

  first 12 hours after surgery (circumcision)

• Motor block score

  first 12 hours after surgery (circumcision)

• Blood pressure (mm/Hg)

  during the surgery (from start time to end time of circumcision)

• Heart rate (beats/min)

  during the surgery (from start time to end time of circumcision)

• Time to discharge from PACU

  First 12 hours after surgery (circumcision)

Other Outcomes (1)

• Parents' satisfaction with pain relief using Likert Scale

  First 5 days after surgery (circumcision)

Study Arms (4)

Caudal block and circumcision with Plastibell,

EXPERIMENTAL

Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using plastibell. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.

Drug: Caudal block; Procedure: Circumcision with Plastibell

Caudal block and circumcision with conventional dissection method

EXPERIMENTAL

Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using the conventional dissection method. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.

Drug: Caudal block; Procedure: Conventional Dissection Method

Dorsal penile nerve block plus ring block and circumcision with Plastibell

ACTIVE COMPARATOR

Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using plastibell.

Drug: Dorsal penile nerve block plus ring block; Procedure: Circumcision with Plastibell

Dorsal penile nerve block plus ring block and circumcision with conventional dissection method

ACTIVE COMPARATOR

Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using the conventional dissection method

Drug: Dorsal penile nerve block plus ring block; Procedure: Conventional Dissection Method

Interventions

Caudal block DRUG

Caudal block will be performed in lateral position with 0.25% bupivacaine in the dose of 0.75 ml/kg containing 1 mic/kg dexmedetomidine. The patients will be turned back to the supine position after the block placement and the head of the patient will be placed in the neutral position. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.

Caudal block and circumcision with Plastibell,; Caudal block and circumcision with conventional dissection method

Dorsal penile nerve block plus ring block DRUG

It will be performed with the child in the supine position. Following skin preparation and palpation of the arch of the lower border of the symphysis pubis, the base of the penis will be gently pulled down, and a 25-G needle will be inserted at 10 and 2.0 "O" clock position to a depth of 0.25-0.5 cm (under Bucks' fascia) and 1 ml + 0.1ml X weight of the patient) of local anesthetic (0.25% bupivacaine) will be injected at each point after negative aspiration and then RB will be done in the form of a circumferential subcutaneous ring at the level of the base of the penis. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.

Dorsal penile nerve block plus ring block and circumcision with Plastibell; Dorsal penile nerve block plus ring block and circumcision with conventional dissection method

Circumcision with Plastibell PROCEDURE

Circumcision with Plastibell

Caudal block and circumcision with Plastibell,; Dorsal penile nerve block plus ring block and circumcision with Plastibell

Conventional Dissection Method PROCEDURE

Conventional Dissection Method

Caudal block and circumcision with conventional dissection method; Dorsal penile nerve block plus ring block and circumcision with conventional dissection method

Eligibility Criteria

• Age: 3 Months - 4 Years
• Gender Eligibility Details: Patient eligibility is based on gender identity
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy,
• Male,
• Ages 3 months to 4 years,
• Scheduled for circumcision for various indications under GA.

You may not qualify if:

• Patients with bleeding or clotting disorders
• Patients with hypospadias, other penile or sacral anomalies
• Patients weight \<3kg.
• Allergy to Local Anesthetic
• Infection at the site of block
• Pre-existing spinal or neurological disease
• Pain medication within the previous 48 hours

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Saud University

Riyadh, Saudi Arabia

Location

Related Publications (26)

• Rossi S, Buonocore G, Bellieni CV. Management of pain in newborn circumcision: a systematic review. Eur J Pediatr. 2021 Jan;180(1):13-20. doi: 10.1007/s00431-020-03758-6. Epub 2020 Aug 3.

  PMID: 32748017 BACKGROUND

• Bawazir OA. A controlled trial of Gomco versus Plastibell for neonatal circumcisions in Saudi Arabia. Int J Pediatr Adolesc Med. 2020 Sep;7(3):132-135. doi: 10.1016/j.ijpam.2019.03.002. Epub 2019 Mar 21.

  PMID: 33094142 BACKGROUND

• Jiang ZL, Sun CW, Sun J, Shi GF, Li H. Subcutaneous tissue-sparing dorsal slit with new marking technique: A novel circumcision method. Medicine (Baltimore). 2019 Apr;98(16):e15322. doi: 10.1097/MD.0000000000015322.

  PMID: 31008987 BACKGROUND

• Weksler N, Atias I, Klein M, Rosenztsveig V, Ovadia L, Gurman GM. Is penile block better than caudal epidural block for postcircumcision analgesia? J Anesth. 2005;19(1):36-9. doi: 10.1007/s00540-004-0287-8.

  PMID: 15674514 BACKGROUND

• Soltany S, Ardestanizadeh A. The study of the factors affecting the time of ring fall off in circumcision using Plastibell. J Family Med Prim Care. 2020 Jun 30;9(6):2736-2740. doi: 10.4103/jfmpc.jfmpc_1261_19. eCollection 2020 Jun.

  PMID: 32984117 BACKGROUND

• O'Sullivan MJ, Mislovic B, Alexander E. Dorsal penile nerve block for male pediatric circumcision--randomized comparison of ultrasound-guided vs anatomical landmark technique. Paediatr Anaesth. 2011 Dec;21(12):1214-8. doi: 10.1111/j.1460-9592.2011.03722.x.

  PMID: 22023417 BACKGROUND

• Wang X, Dong C, Beekoo D, Qian X, Li J, Shang-Guan WN, Jiang X. Dorsal Penile Nerve Block via Perineal Approach, an Alternative to a Caudal Block for Pediatric Circumcision: A Randomized Controlled Trial. Biomed Res Int. 2019 Mar 27;2019:6875756. doi: 10.1155/2019/6875756. eCollection 2019.

  PMID: 31032356 BACKGROUND

• Teunkens A, Van de Velde M, Vermeulen K, Van Loon P, Bogaert G, Fieuws S, Rex S. Dorsal penile nerve block for circumcision in pediatric patients: A prospective, observer-blinded, randomized controlled clinical trial for the comparison of ultrasound-guided vs landmark technique. Paediatr Anaesth. 2018 Aug;28(8):703-709. doi: 10.1111/pan.13429. Epub 2018 Jul 23.

  PMID: 30035357 BACKGROUND

• Heller GZ, Manuguerra M, Chow R. How to analyze the Visual Analogue Scale: Myths, truths and clinical relevance. Scand J Pain. 2016 Oct;13:67-75. doi: 10.1016/j.sjpain.2016.06.012. Epub 2016 Jul 27.

  PMID: 28850536 BACKGROUND

• Chan KH, Shah A, Moser EA, Szymanski K, Whittam BM, Misseri R, Kaefer M, Rink R, Cain MP. Comparison of Intraoperative and Early Postoperative Outcomes of Caudal vs Dorsal Penile Nerve Blocks for Outpatient Penile Surgeries. Urology. 2018 Aug;118:164-171. doi: 10.1016/j.urology.2017.08.062. Epub 2017 Nov 6.

  PMID: 29122625 BACKGROUND

• Panda A, Bajwa SJ, Sen S, Parmar SS. Penile block for paediatric urological surgery: A comparative evaluation with general anaesthesia. Indian J Urol. 2011 Oct;27(4):457-64. doi: 10.4103/0970-1591.91432.

  PMID: 22279309 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

• Yao Y, Yu C, Zhang X, Guo Y, Zheng X. Caudal and intravenous dexmedetomidine similarly prolong the duration of caudal analgesia in children: A randomized controlled trial. Paediatr Anaesth. 2018 Oct;28(10):888-896. doi: 10.1111/pan.13469.

  PMID: 30302881 BACKGROUND

• Sharara-Chami R, Lakissian Z, Charafeddine L, Milad N, El-Hout Y. Combination Analgesia for Neonatal Circumcision: A Randomized Controlled Trial. Pediatrics. 2017 Dec;140(6):e20171935. doi: 10.1542/peds.2017-1935. Epub 2017 Nov 17.

  PMID: 29150457 BACKGROUND

• Munevveroglu C, Gunduz M. Postoperative pain management for circumcision; Comparison of frequently used methods. Pak J Med Sci. 2020 Jan-Feb;36(2):91-95. doi: 10.12669/pjms.36.2.505.

  PMID: 32063938 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 BACKGROUND

• Sinkey RG, Eschenbacher MA, Walsh PM, Doerger RG, Lambers DS, Sibai BM, Habli MA. The GoMo study: a randomized clinical trial assessing neonatal pain with Gomco vs Mogen clamp circumcision. Am J Obstet Gynecol. 2015 May;212(5):664.e1-8. doi: 10.1016/j.ajog.2015.03.029. Epub 2015 Mar 17.

  PMID: 25794628 BACKGROUND

• Mehmood T, Azam H, Tariq M, Iqbal Z, Mehmood H, Shah SA. Plastibell Device Circumcision versus Bone Cutter Technique in terms of Operative Outcomes and Parent's Satisfaction. Pak J Med Sci. 2016 Mar-Apr;32(2):347-50. doi: 10.12669/pjms.322.9510.

  PMID: 27182237 BACKGROUND

• Margetts L, Carr A, McFadyen G, Lambert A. A comparison of caudal bupivacaine and ketamine with penile block for paediatric circumcision. Eur J Anaesthesiol. 2008 Dec;25(12):1009-13. doi: 10.1017/S0265021508004833. Epub 2008 Jul 24.

  PMID: 18652709 BACKGROUND

• Atasever AG, Ermis O, Demir BS, Kasali K, Karadeniz MS. Comparison of bupivacaine alone and in a combination with lidocaine for caudal block in patients undergoing circumcision: A historical cohort study. Turk J Urol. 2019 Nov 29;46(3):243-248. doi: 10.5152/tud.2019.19191. Print 2020 May.

  PMID: 32401707 BACKGROUND

• Sottas CE, Anderson BJ. Dexmedetomidine: the new all-in-one drug in paediatric anaesthesia? Curr Opin Anaesthesiol. 2017 Aug;30(4):441-451. doi: 10.1097/ACO.0000000000000488.

  PMID: 28537937 BACKGROUND

• Li S, Liu T, Xia J, Jia J, Li W. Effect of dexmedetomidine on prevention of postoperative nausea and vomiting in pediatric strabismus surgery: a randomized controlled study. BMC Ophthalmol. 2020 Mar 5;20(1):86. doi: 10.1186/s12886-020-01359-3.

  PMID: 32138784 BACKGROUND

• Mahmoud M, Mason KP. Dexmedetomidine: review, update, and future considerations of paediatric perioperative and periprocedural applications and limitations. Br J Anaesth. 2015 Aug;115(2):171-82. doi: 10.1093/bja/aev226.

  PMID: 26170346 BACKGROUND

• Bellon M, Le Bot A, Michelet D, Hilly J, Maesani M, Brasher C, Dahmani S. Efficacy of Intraoperative Dexmedetomidine Compared with Placebo for Postoperative Pain Management: A Meta-Analysis of Published Studies. Pain Ther. 2016 Jun;5(1):63-80. doi: 10.1007/s40122-016-0045-2. Epub 2016 Feb 10.

  PMID: 26861737 BACKGROUND

• Mittino I, Sangalli M, Fabbri F, Sozzi F, Ghezzi M, Zanni G, Cestari A. Ischemia of the glans 24 hours after circumcision: A case report and therapeutic solution. Urologia. 2018 Nov;85(4):174-176. doi: 10.1177/0391560318761288. Epub 2018 Mar 26.

  PMID: 30426879 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Agnosia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Pain, Postoperative; Acute Pain

Interventions

Circumcision, Male

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Mansoor Aqil, FCPS

  King Saud University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mansoor Aqil, FCPS

CONTACT

00966507221058; maqil@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All patients will receive general anesthesia. Patients will be randomly allocated to one of 4 arms of the study: * Group 1 will receive are caudal block (CB) and circumcision with Plastibell, * Group 2 will receive CB and circumcision with conventional dissection method (CDM), * Group 3 will receive dorsal penile block (DPNB) and ring block (RB) and circumcision with Plastibell, and * Group 4 will receive DPNB+ RB and circumcision with CDM.

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: February 10, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: February 10, 2022

Record last verified: 2022-01

Locations

SA (1)