AnesthesiaPhase 3NCT05233683
Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children
A Phase 3 study testing Caudal block, Dorsal penile nerve block plus ring block and Circumcision with Plastibell in people with Anesthesia and Anesthesia, Local, run by King Saud University at 1 site in Saudi Arabia.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 months to 4 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Anesthesia, Local, Analgesia
- What is being tested?
- Caudal block, Dorsal penile nerve block plus ring block and Circumcision with Plastibell
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2022to Mar 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 4 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy,
- Male,
- Ages 3 months to 4 years,
- Scheduled for circumcision for various indications under GA.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
King Saud University
Riyadh
Mansoor Aqil, FRCP, 00966507221058, maqil@ksu.edu.sa
Mansoor Aqil
About this study
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.
Read the 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.
- Conditions
- Anesthesia, Anesthesia, Local, Analgesia, Pediatric ALL, Pain, Postoperative, Pain, Acute
- Being tested
- Caudal block, Dorsal penile nerve block plus ring block, Circumcision with Plastibell, Conventional Dissection Method
- Medical subject headings
- Agnosia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caudal blockDrug
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.
Dorsal penile nerve block plus ring blockDrug
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.
Circumcision with PlastibellProcedure or surgery
Circumcision with Plastibell
Conventional Dissection MethodProcedure or surgery
Conventional Dissection Method
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: Drug: Dorsal penile nerve block plus ring block; Procedure: Conventional Dissection Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: First 12 hours after surgery/intervention (circumcision)
Secondary outcomes (13)
Number of participants that needed rescue analgesia
Number of participants that needed rescue analgesia in PACU and ward
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: First 5 days after surgery (circumcision)
Number of patients experiencing urinary retention
Measured as: no urine output after intervention.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: first 5 days after surgery (circumcision)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansoor Aqil, King Saud University
- Investigators
- Mansoor Aqil, FCPS, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233683
- Sponsor's protocol ID
- E-21-5965
- Status last verified
- Jan 2022
- First submitted
- 22 Oct 2021
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32748017Bawazir 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.
PubMed 33094142Jiang 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.
PubMed 31008987Weksler 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.
PubMed 15674514Soltany 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.
PubMed 32984117O'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.
PubMed 22023417Wang 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.
PubMed 31032356Teunkens 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.
PubMed 30035357Heller 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.
PubMed 28850536Chan 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.
PubMed 29122625Panda 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.
PubMed 22279309Sandeman 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.
PubMed 20514962Yao 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.
PubMed 30302881Sharara-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.
PubMed 29150457Munevveroglu 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.
PubMed 32063938
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children
- ClinicalTrials.gov ID
- NCT05233683
- Acronym / sponsor ID
- E-21-5965
- Conditions
- Anesthesia, Anesthesia, Local, Analgesia, Pediatric ALL, Pain, Postoperative, Pain, Acute
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Caudal block and circumcision with Plastibell, | Experimental | Drug: Caudal block, Procedure: Circumcision with PlastibellCaudal 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. |
| Caudal block and circumcision with conventional dissection method | Experimental | Drug: Caudal block, Procedure: Conventional Dissection MethodCaudal 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. |
| Dorsal penile nerve block plus ring block and circumcision with Plastibell | Active comparator | Drug: Dorsal penile nerve block plus ring block, Procedure: Circumcision with PlastibellDorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using plastibell. |
| Dorsal penile nerve block plus ring block and circumcision with conventional dissection method | Active comparator | Drug: Dorsal penile nerve block plus ring block, Procedure: Conventional Dissection MethodDorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using the conventional dissection method |
Who may qualify
- Ages
- 3 months to 4 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy,
- Male,
- Ages 3 months to 4 years,
- Scheduled for circumcision for various indications under GA.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caudal blockCaudal 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. | Drug | Caudal block and circumcision with Plastibell,, Caudal block and circumcision with conventional dissection method |
| Dorsal penile nerve block plus ring blockIt 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. | Drug | 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 PlastibellCircumcision with Plastibell | Procedure or surgery | Caudal block and circumcision with Plastibell,, Dorsal penile nerve block plus ring block and circumcision with Plastibell |
| Conventional Dissection MethodConventional Dissection Method | Procedure or surgery | Caudal block and circumcision with conventional dissection method, Dorsal penile nerve block plus ring block and circumcision with conventional dissection method |
Primary outcome
Efficacy of analgesia using FLACC Scale
Time frame: First 12 hours after surgery/intervention (circumcision)
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.
Duration of analgesia
Time frame: First 12 hours after surgery/intervention (circumcision)
To compare the duration of post-OP analgesia produced by CB and DPNB plus RB in children undergoing circumcision with two different surgical techniques.
13 secondary outcomes
Number of participants that needed rescue analgesia
Time frame: first 12 hours after surgery (circumcision)
Motor block score
Time frame: first 12 hours after surgery (circumcision)
Blood pressure (mm/Hg)
Time frame: during the surgery (from start time to end time of circumcision)
Heart rate (beats/min)
Time frame: during the surgery (from start time to end time of circumcision)
Time to discharge from PACU
Time frame: First 12 hours after surgery (circumcision)
Number of patients with infection
Time frame: First 5 days after surgery (circumcision)
Number of patients experiencing urinary retention
Time frame: First 12 hours after surgery (circumcision)
Number of Participants with sedation
Time frame: First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Number of Participants with nausea
Time frame: First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Number of Participants with vomiting
Time frame: First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Number of Participants with agitation
Time frame: 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
Time frame: First 12 hours after surgery/intervention: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
Total paracetamol doses administered
Time frame: first 5 days after surgery (circumcision)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Background: PubMed 32748017Rossi 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.
- Background: PubMed 33094142Bawazir 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.
- Background: PubMed 31008987Jiang 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.
- Background: PubMed 15674514Weksler 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.
- Background: PubMed 32984117Soltany 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.
- Background: PubMed 22023417O'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.
- Background: PubMed 31032356Wang 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.
- Background: PubMed 30035357Teunkens 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.
- Background: PubMed 28850536Heller 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.
- Background: PubMed 29122625Chan 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.
- Background: PubMed 22279309Panda 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.
- Background: PubMed 20514962Sandeman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mansoor Aqil, FCPS principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Caudal block, Dorsal penile nerve block plus ring block and Circumcision with Plastibell in people with Anesthesia and Anesthesia, Local, run by King Saud University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mansoor Aqil, FCPS (00966507221058, maqil@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of analgesia using FLACC Scale (time frame: First 12 hours after surgery/intervention (circumcision)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05233683, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022.