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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain, Postoperative; Analgesia; Anesthesia, Local; Pain, Acute; Pediatric ALL; Anesthesia
• Intervention / Treatment: Drug: Caudal block; Procedure: Circumcision with Plastibell; Procedure: Conventional Dissection Method; Drug: Dorsal penile nerve block plus ring block

Detailed Description

Circumcision is one of the most commonly performed operations in the paediatric population and is a painful procedure. Circumcision is performed with two popular techniques, Plastibell and conventional dissection method. Two anesthetic techniques are commonly used for intra-operative (OP) and post-OP pain relief i.e CB and DPNB+RB at the base of the penis. Addition of dexmedetomidine to bupivacaine prolongs duration of analgesia of CB. Both anaesthesia techniques of pain relief have certain advantages and disadvantages and the superiority of any technique over the other has not been established.

There are very few randomized controlled trials comparing these two methods of intra-OP and post-OP pain relief, for different surgical techniques of circumcision 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.

Poorly treated postoperative pain leads to fatigue and metabolic, endocrine, and immunological changes can lead to prolonged convalescence following surgery and is traumatic to the pediatric patients and their parents. In this study, the investigators planned to compare the two most popular methods of pain relief during and after circumcision, along with parents' satisfaction.

This research will guide the anesthetists regarding the selection of appropriate techniques of intra-OP and post-OP analgesia and in light of intra and post-OP data; and parents' satisfaction.

In this prospective randomized study the investigators plan to compare the quality of intra and post OP analgesia and the duration of post-OP analgesia produced by CB and DPNB +RB, need of rescue analgesia with both of the techniques of surgery, intra-OP hemodynamic variations, residual motor block, and adverse effects and parents' satisfaction with both of the anesthesia and the surgical techniques.

Research Objectives:

To evaluate and compare the intra and post-OP pain relief under CB and DPNB plus RB in pediatric patients undergoing circumcision with different surgical techniques and assessment of parents' satisfaction

This study may guide the anesthetists for the selection of appropriate techniques of intra and post-OP analgesia and their complications for different surgical techniques of circumcision and also about parent's satisfaction with the anesthetic technique.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mansoor Aqil, FCPS; Phone Number: 00966507221058; Email: maqil@ksu.edu.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Saud University
    • Contact: Mansoor Aqil, FRCP; Phone Number: 00966507221058; Email: maqil@ksu.edu.sa
    • Principal Investigator: Mansoor Aqil
    • Sub-Investigator: Abdulrahman Alzahem
    • Sub-Investigator: Mueen ullah Khan
    • Sub-Investigator: Fatma Dammas
    • Sub-Investigator: Abdulaziz Ahmed
    • Sub-Investigator: Abdul Sattar Narejo
    • Sub-Investigator: Rashid Saeed Khokhar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Caudal block and circumcision with Plastibell,; 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; 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.; Procedure: Circumcision with Plastibell; Circumcision with Plastibell
Experimental: Caudal block and circumcision with conventional dissection method; 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; 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.; Procedure: Conventional Dissection Method; Conventional Dissection Method
Active Comparator: Dorsal penile nerve block plus ring block and circumcision with Plastibell; Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using plastibell.	Procedure: Circumcision with Plastibell; Circumcision with Plastibell; Drug: Dorsal penile nerve block plus ring block; 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.
Active Comparator: Dorsal penile nerve block plus ring block and circumcision with conventional dissection method; Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using the conventional dissection method	Procedure: Conventional Dissection Method; Conventional Dissection Method; Drug: Dorsal penile nerve block plus ring block; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants that needed rescue analgesia	Number of participants that needed rescue analgesia in PACU and ward	first 12 hours after surgery (circumcision)
Motor block score	Motor block score will be recorded (0=spontaneous movements of hips, knees and ankles, 1=movements of knees and ankles but no movements of hips, 2=only movements of ankles, and 3=no movements of lower limbs).	first 12 hours after surgery (circumcision)
Blood pressure (mm/Hg)	Patients will receive fentanyl 0.5 mic/kg, if at any stage HR or BP increased 25% more than baseline value and the total dose of rescue analgesia received intra-operatively will be recorded.	during the surgery (from start time to end time of circumcision)
Heart rate (beats/min)	Patients will receive fentanyl 0.5 mic/kg, if at any stage HR or BP increased 25% more than baseline value and the total dose of rescue analgesia received intra-operatively will be recorded.	during the surgery (from start time to end time of circumcision)
Time to discharge from PACU	Amount of time the patient stays in PACU after the surgery. This will be a continuous variable (time).	First 12 hours after surgery (circumcision)
Number of patients with infection	Number of patients experiencing infection at site of circumcision. It will be recorded as yes/no.	First 5 days after surgery (circumcision)
Number of patients experiencing urinary retention	Measured as: no urine output after intervention.	First 12 hours after surgery (circumcision)
Number of Participants with sedation	Sedation will be measured using the The Pasero Opioid-Induced Sedation Scale (POSS). POSS is a standardized approach to assessing opioid-induced sedation and instituting interventions. The POSS scores are S ("sleep, easy to arouse"), 1 ("awake and alert"), 2 ("slightly drowsy, easily aroused"), 3 ("frequently drowsy, arousable, drifts off to sleep during conversation"), and 4 ("somnolent, minimal, or no response to verbal or physical stimulation"). Scores of S, 1, or 2 are considered acceptable; the opioid dose may be increased if needed.	First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Number of Participants with nausea	Will be recorded as yes/no	First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Number of Participants with vomiting	Will be recorded as yes/no	First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Number of Participants with agitation	Will be recorded as yes/no	First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Number of Participants with penile hematoma	Will be recorded as yes/no	First 12 hours after surgery/intervention: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Total paracetamol doses administered	Amount of paracetamol required by the patient for pain control	first 5 days after surgery (circumcision)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parents' satisfaction with pain relief using Likert Scale	Parents' satisfaction with pain relief will be measured using a Likert Scale (0-10)	First 5 days after surgery (circumcision)

Collaborators and Investigators

• Sponsor: King Saud University
• Investigators: Principal Investigator: Mansoor Aqil, FCPS, King Saud University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Pediatrics. 2018 Apr 30;:
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: E-21-5965

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No